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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/NCT03650556
Registration number
NCT03650556
Ethics application status
Date submitted
1/08/2018
Date registered
28/08/2018
Date last updated
27/04/2022
Titles & IDs
Public title
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
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Scientific title
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)
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Secondary ID [1]
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ABT-CIP-10239
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Persistent Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Experimental: Ablation - Enrolled subjects who had the investigational catheter inserted into their vasculature for pulmonary vein isolation by radiofrequency ablation treatment TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE).
Treatment: Devices: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF
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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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Rate of Subjects With a Device and/or Procedure-related SAE.
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Assessment method [1]
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Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.
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Timepoint [1]
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Within 7 days of initial or repeat procedure performed =180 days of initial procedure
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Primary outcome [2]
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Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.
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Assessment method [2]
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The following events were considered a failure for AF/AFL/AT recurrence:
If AF/AFL/AT recurrence (>30 second episode) occurred at any time after the therapy consolidation period (>180 days after the initial procedure), or
If the subject required a repeat procedure for the treatment of AF after the therapy consolidation period, the subject was considered an effectiveness endpoint failure regardless of documentation of a >30 second AF/AFL/AT episode, or
If the subject required a second repeat procedure at any time after the initial procedure, or
If the subject required a new AAD or a previously failed AAD at a dose greater than the highest ineffective historical dose for AF after the therapy consolidation period, or
If the subject required a cardioversion (electrical or pharmacological) for the treatment of AF after the therapy consolidation period, or
If the subject had a continuous atrial arrhythmia throughout a 12-lead ECG recording after the the
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Timepoint [2]
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15 months
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Secondary outcome [1]
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Acute Procedural Success
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Assessment method [1]
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Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins
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Timepoint [1]
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Immediate post procedure
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Secondary outcome [2]
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15-month Success Off of Antiarrhythmic Drugs
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Assessment method [2]
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Percent of subjects off all AADs taken to treat AF/AFL/AT who achieve15-month success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods.
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Timepoint [2]
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15 months
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Secondary outcome [3]
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15 Month Single Procedure Success
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Assessment method [3]
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Percent of subjects who achieve 15-month single procedure success, defined as freedom from documented AF/AFL/AT recurrence (episodes >30 seconds) during the 9-month period following the blanking and therapy consolidation periods after a single ablation procedure. Any repeat ablation procedure required by the subject at any time was deemed an effectiveness failure in this analysis.
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Timepoint [3]
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15 months
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Eligibility
Key inclusion criteria
1. Patient must provide written informed consent prior to any clinical investigation
related procedure.
2. Documented symptomatic persistent AF, which is defined as continuous AF sustained
beyond 7-days and less than 1-year that is documented by (1) a physician's note and
(2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF
3. Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as
evidenced by recurrent symptomatic AF
4. Age 18 years or older
5. Able and willing to comply with all pre-, post-, and follow-up testing and
requirements
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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
1. Continuous AF > 12 months (longstanding persistent AF)
2. Previous left atrial surgical or catheter ablation for atrial fibrillation or a
previous procedure that required an incision in the left atrium with resulting scar
3. Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial
procedure
4. CABG surgery within the 6-months (180-days) prior to the initial procedure
5. Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or
replacement and/or presence of a prosthetic or mechanical valve)
6. Any carotid stenting or endarterectomy
7. Documented or known left atrial thrombus on imaging
8. Left atrial diameter > 50 mm (parasternal long axis view or by CT)
9. Left ventricular ejection fraction < 40%
10. Unable to take anticoagulation medication due to contraindication or intolerance
11. History of blood clotting or bleeding abnormalities
12. Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary
intervention (PCI) within the 3-months (90-days) prior to the initial procedure
13. Documented thromboembolic event (including TIA) within the 12-months (365 days) prior
to the initial procedure
14. Rheumatic heart disease
15. Uncontrolled heart failure or NYHA functional class III or IV
16. Severe mitral regurgitation (regurgitant volume = 60 mL/beat, regurgitant fraction =
50%, and/or effective regurgitant orifice area = 0.40cm2)
17. Awaiting cardiac transplantation or other cardiac surgery within the 12-months (365
days) following the initial ablation procedure
18. Unstable angina at the time of the initial procedure
19. Acute illness or active systemic infection or sepsis
20. AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication,
major surgical procedure in the preceding 3-months, or other reversible or non-cardiac
cause
21. Diagnosed atrial myxoma
22. Presence of implanted implantable cardioverter defibrillator (ICD) or cardiac
resynchronization therapy-defibrillator (CRT-D)
23. Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or
chronic obstructive pulmonary disease) or any other disease or malfunction of the
lungs or respiratory system that produces chronic symptoms
24. Significant congenital anomaly or other anatomic or comorbid medical problem that in
the opinion of the investigator would preclude enrollment in this study or compliance
with the follow-up requirements or impact the scientific soundness of the clinical
trial results
25. Pregnant or nursing subjects and those who plan pregnancy during the clinical
investigation follow-up period
26. Enrollment in an investigational study evaluating another device, biologic, or drug
that may interfere with this clinical investigation at the time of the initial
procedure or within 30 days prior to the initial procedure
27. Presence of any condition that precludes appropriate vascular access or manipulation
of catheter
28. Life expectancy less than 12-months
29. Body mass index > 40 kg/m2
30. Known sensitivity to contrast media (if needed during the procedure) that cannot be
controlled with pre-medication
31. Renal failure requiring dialysis
32. Vulnerable subject
33. History of atriotomy or ventriotomy
34. Implanted endocardial left atrial appendage occlusion device
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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
Completed
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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
28/09/2018
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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
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Actual
11/01/2021
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Sample size
Target
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Accrual to date
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Final
224
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Royal Melbourne Hospital - City Campus - Parkville
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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Mississippi
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Missouri
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United States of America
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Nebraska
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New York
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Ohio
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United States of America
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South Carolina
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United States of America
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical investigation is intended to demonstrate the safety and effectiveness of the
TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac
electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic
persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency
(RF) generator and three-dimensional mapping system. This clinical investigation will be
conducted under an investigational device exemption (IDE) and is intended to support market
approval of the TactiCath SE ablation catheter for the treatment of drug refractory,
symptomatic persistent atrial fibrillation in the United States.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03650556
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03650556
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