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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/NCT01534234




Registration number
NCT01534234
Ethics application status
Date submitted
27/09/2011
Date registered
16/02/2012
Date last updated
11/01/2019

Titles & IDs
Public title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Scientific title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Secondary ID [1] 0 0
ITSY06 - RESPOND CRT
Universal Trial Number (UTN)
Trial acronym
RESPOND-CRT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure NYHA Class III and Ambulatory IV 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Devices - PARADYM RF SONR
Treatment: Devices - PARADYM RF SONR

Experimental: SonR group - SonR CRT Optimization

Active Comparator: ECHO group - Echocardiographic Optimization


Treatment: Devices: PARADYM RF SONR
SonR CRT Optimization

Treatment: Devices: PARADYM RF SONR
Echocardiography Optimization
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of SonR CRT Optimization Effectiveness in terms of proportion of responders at 12 months. The investigational(SonR)and control groups(ECHO)will be compared in a non-inferiority context employing a clinically meaningful difference of 10%.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months)
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months)
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 12 months
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Evaluation of CRT effectiveness and CRT therapy: Proportion of patients worsened at 12 months
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
SonR tip lead pacing threshold
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
SonR tip lead sensing threshold
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
SonR tip lead pacing impedance
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause
Timepoint [6] 0 0
24 months
Secondary outcome [7] 0 0
Report Heart Failure-related events to assess CRT effectiveness
Timepoint [7] 0 0
24 months
Secondary outcome [8] 0 0
Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL)
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class)
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Evaluation of CRT effectiveness: Report echocardiographic parameters trend at M12
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group
Timepoint [11] 0 0
18/24 months
Secondary outcome [12] 0 0
Evaluation of the time spent for CRT optimization by the physician on optimization in each group (sonR and ECHO)
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO)
Timepoint [13] 0 0
24 months
Secondary outcome [14] 0 0
Report Adverse Events for both group to assess CRT effectiveness / System Safety
Timepoint [14] 0 0
24 months

Eligibility
Key inclusion criteria
1. Patient eligible with class I and IIa indication for implantation of a CRT-D device
according to current available guidelines ;

2. Modere,Severe HF (NYHA Class III or ambulatory IV)

3. LVEF = 35 %

4. LBBB: QRS = 120 ms ; non-LBBB : QRS = 150 ms

5. On a stable, optimal drug regimen

6. Patient is in sinus rhythm at the time of enrollment;

7. Signed and dated informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial
infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance,
hypoxia or sepsis, uncorrected at the time of the enrolment;

2. Incessant ventricular tachyarrhythmia;

3. Unstable angina, or acute MI, CABG, or PTCA within the past 4 weeks;

4. Correctable valvular disease that is the primary cause of heart failure;

5. Recent CVA or TIA (within the previous 3 months);

6. Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation)
within the past month;

7. Post heart transplant (patients who are waiting for a heart transplant are allowed in
the study);

8. Renal failure (GFR<15 ml/min/1.73m2) or on dialysis

9. Previous implant with a CRT/CRT-D device;

10. Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or
ICD devices or RA leads should be removed prior to implant with the Paradym RF SONR
CRT-D);

11. Already included in another clinical study that could confound the results of this
study;

12. Life expectancy less than 1 year;

13. Inability to understand the purpose of the study or to understand and complete the QOL
questionnaire;

14. Unavailability for scheduled follow-up or refusal to cooperate;

15. Sensitivity to 1 mg dexamethasone sodium phosphate (DSP)

16. Age of less than 18 years;

17. Pregnancy

18. Drug addiction or abuse

19. Under guardianship

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2019
Actual
Sample size
Target
Accrual to date
Final
1039
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
4104 - Brisbane
Recruitment postcode(s) [2] 0 0
6000 - Perth
Recruitment outside Australia
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Alabama
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South Carolina
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Texas
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Austria
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Feldkirch
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Austria
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Innsbruck
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Wien
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France
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Brest
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Grenoble
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Lille
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Massy
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Nantes
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Paris
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Pessac
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Poitiers
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Rouen
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Saint Etienne
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Toulouse
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Tours
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Hannover
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Kiel
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Magdeburg
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Münster
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Reinbek
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Alessandria
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Ancona
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Caserta
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Catania
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Cesena
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Cuneo
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Mirano
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Trieste
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Udine
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Porto
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Vila Nova de Gaia
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Slovenia
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Ljubljana
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Alicante
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Badalona
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Barcelona
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Granada
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Madrid
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Majadahonda
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Vigo
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Switzerland
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Lausanne
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Switzerland
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Lugano
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Birmingham
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Cambridge
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Chertsey
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Cottingham
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Leeds
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Leicester
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MicroPort CRM
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sorin CRM
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess the safety and effectiveness of the automatic
atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in
the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device
(Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of
the atrial pacing lead, and compatible SmartView programming software.

This study will evaluate the effectiveness of the automatic optimization algorithm in
increasing the rate of patients responding to the therapy as compared to an echocardiographic
optimization method.

This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01534234
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Josep Brugada
Address 0 0
Hospital Clinic of Barcelona
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01534234