Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650556
• Other study ID #: ABT-CIP-10239
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: January 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 11, 2021
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™
Ablation procedure for Persistent AF

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Melbourne Hospital - City Campus	Parkville	Victoria
United States	Emory University Hosptial	Atlanta	Georgia
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Johns Hopkins University Hospital	Baltimore	Maryland
United States	University Hospital (UAB)	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	St. Bernards	Jonesboro	Arkansas
United States	Scripps Health	La Jolla	California
United States	Bryan Heart	Lincoln	Nebraska
United States	Arkansas Heart Hosptial	Little Rock	Arkansas
United States	South Denver Cardiology Associates	Littleton	Colorado
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York University Hospital	New York	New York
United States	Florida Hospital	Orlando	Florida
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Sequoia Hospital	Redwood City	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Subjects With a Device and/or Procedure-related SAE.	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.	Within 7 days of initial or repeat procedure performed =180 days of initial procedure
Primary	Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence.	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	15 months
Secondary	Acute Procedural Success	Percent of subjects who achieve acute procedural success defined as confirmation of entrance block in all pulmonary veins	Immediate post procedure
Secondary	15-month Success Off of Antiarrhythmic Drugs	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.	15 months
Secondary	15 Month Single Procedure Success	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.	15 months