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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03170349
Registration number
NCT03170349
Ethics application status
Date submitted
26/05/2017
Date registered
31/05/2017
Date last updated
3/05/2024
Titles & IDs
Public title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
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Scientific title
The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
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Secondary ID [1]
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2016-05
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Universal Trial Number (UTN)
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Trial acronym
CLASP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mitral Valve Regurgitation
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Mitral Valve Repair
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System -
Treatment: Devices: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Major Adverse Events (MAE)
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Assessment method [1]
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Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days
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Timepoint [1]
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30 days
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Primary outcome [2]
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Device Success
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Assessment method [2]
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Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.
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Timepoint [2]
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Exit from the cardiac catheterization laboratory
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Primary outcome [3]
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Number of Participants With Procedural Success
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Assessment method [3]
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Device success with evidence of mitral regurgitation reduction = MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed per independent echocardiography core laboratory.
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Timepoint [3]
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through discharge
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Primary outcome [4]
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Clinical Success
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Assessment method [4]
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Procedural success with evidence of MR reduction = MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
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Timepoint [4]
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30 days
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Secondary outcome [1]
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Mitral Regurgitation Reduction
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Assessment method [1]
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Mitral regurgitation reduction at 30 days, 6 months, 1 year and annually thereafter over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
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Timepoint [1]
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baseline, 30 days, 6 months, 1 year, 2 year
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Secondary outcome [2]
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All-cause Mortality
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Assessment method [2]
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All-cause mortality at 30 days, 6 months, 1 year and annually thereafter
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Timepoint [2]
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30 days, 6 months, 1 year, 2 year
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Secondary outcome [3]
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Recurrent Heart Failure Hospitalization
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Assessment method [3]
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Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter
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Timepoint [3]
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30 days , 6 months, 1 year, 2 year
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Secondary outcome [4]
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Re-intervention Rates for Mitral Regurgitation
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Assessment method [4]
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Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter
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Timepoint [4]
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30 days, 6 months, 1 year, 2 year
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Secondary outcome [5]
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Composite of Major Adverse Events (MAE) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Re-intervention for Study Device Related Complications
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Assessment method [5]
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Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 6 months, 1 year and annually thereafter
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Timepoint [5]
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6 months, 1 year, 2 year
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Secondary outcome [6]
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Change in Left Ventricular End Diastolic Volume (LVEDV)
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Assessment method [6]
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Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline
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Timepoint [6]
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6 months, 1 year, 2 year
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Secondary outcome [7]
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Change in Left Ventricular End Systolic Volume (LVESV)
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Assessment method [7]
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Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline
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Timepoint [7]
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6 months, 1 year, 2 year
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Secondary outcome [8]
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Change in Pulmonary Artery Systolic Pressure
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Assessment method [8]
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Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline
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Timepoint [8]
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baseline, 6 months, 1 year
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Secondary outcome [9]
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Change in Six Minute Walk Test (6MWT) Distance
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Assessment method [9]
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Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline
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Timepoint [9]
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6 months, 1 year
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Secondary outcome [10]
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Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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Assessment method [10]
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Mean KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
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Timepoint [10]
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baseline, 30 days, 6 months, 1 year
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Secondary outcome [11]
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Change in Quality of Life (QoL) Score, as Measured by EQ5D
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Assessment method [11]
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Change in Quality of Life (QoL) score, as measured by EQ5D at 30 days, 6 months over baseline. The EQ5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life.
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Timepoint [11]
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baseline, 30 days, 6 months, 1 year
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Secondary outcome [12]
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Change in NYHA Functional Classification
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Assessment method [12]
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Change in NYHA Functional Classification at 6 months and 1 year over baseline. NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
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Timepoint [12]
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baseline, 6 months, 1 year, 2 year
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Secondary outcome [13]
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Change NT-pro-BNP Level
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Assessment method [13]
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Change in NT-pro-BNP level at 6 months and 1 year and annually thereafter over baseline
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Timepoint [13]
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baseline, 6 months, 1 year, 2 year
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Secondary outcome [14]
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Change in BNP Level
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Assessment method [14]
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Change in BNP level at 6 months, 1 year and annually thereafter over baseline
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Timepoint [14]
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baseline, 6 months, 1 year, 2 year
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Secondary outcome [15]
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Change in Tricuspid Regurgitation (TR) at 6 Months, 1 Year and Annually Thereafter Over Baseline
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Assessment method [15]
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Change in TR over baseline at 6 months, and 1 year. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.
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Timepoint [15]
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6 months, 1 year, 2 year
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Secondary outcome [16]
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Change in Effective Regurgitant Orifice Area (EROA)
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Assessment method [16]
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Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, 1 year and annually thereafter over baseline.
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Timepoint [16]
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baseline, 30 days, 6 months, 1 year, 2 year
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Secondary outcome [17]
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Change in Mitral Regurgitant Volume
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Assessment method [17]
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Change in mitral regurgitant volume at 30 days, 6 months, 1 year and annually thereafter over baseline
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Timepoint [17]
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baseline, 30 days, 6 months, 1 year, 2 year
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Eligibility
Key inclusion criteria
- Signed and dated IRB/ethics committee approved study consent form prior to study
related procedures
- Eighteen (18) years of age or older
- New York Heart Association (NYHA) Functional Class II-IVa heart failure despite
optimal medical therapy
- Candidacy for surgical mitral valve repair or replacement determined by Heart Team
evaluation
- Clinically significant mitral regurgitation (moderate-to-severe or severe mitral
regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic
echocardiography (TTE).
- The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be
considered clinically insignificant.
- Mitral valve area (MVA) = 4.0 cm² as measured by planimetry. If MVA by planimetry is
not measurable, pressure half-time measurement is acceptable.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Leaflet anatomy which may preclude PASCAL device implantation, proper device
positioning on the leaflets, or sufficient reduction in mitral regurgitation.
- Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is
not measurable, PHT measurement is acceptable)
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Physical evidence of right sided congestive heart failure and echocardiographic
evidence of severe right ventricular dysfunction
- Concurrent medical condition with a life expectancy of less than 12 months in the
judgment of the Investigator
- Patient is currently participating or has participated in another investigational drug
or device clinical study where the primary study endpoint was not reached at time of
enrollment
- Patient is under guardianship
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
124
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Recruitment in Australia
Recruitment state(s)
ChermsideNSW
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Recruitment hospital [1]
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Metro North Hospital & Health Service, The Prince Charles Hospital - Brisbane
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Recruitment hospital [2]
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Sydney Local Health District, Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
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QLD 4032 - Brisbane
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Michigan
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Country [5]
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United States of America
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State/province [5]
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New Jersey
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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United States of America
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State/province [8]
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Virginia
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Country [9]
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Canada
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State/province [9]
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British Columbia
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Country [10]
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Canada
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State/province [10]
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Ontario
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Country [11]
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Germany
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State/province [11]
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Bonn
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Country [12]
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Greece
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State/province [12]
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Athens
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Country [13]
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Italy
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State/province [13]
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Milano
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Country [14]
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Switzerland
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State/province [14]
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Bern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Edwards Lifesciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the safety, performance and clinical outcomes of the
Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03170349
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gideon Cohen, MD
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Address
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Sunnybrook Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03170349
Download to PDF