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

NCT ID: NCT03650556

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-28
• Study Completion Date: 2021-01-11

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.

Conditions

Persistent Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Intervention Type: DEVICE

Ablation procedure for Persistent AF

Interventions

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Ablation procedure for Persistent AF

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital (UAB)

Birmingham, Alabama, United States

St. Bernards

Jonesboro, Arkansas, United States

Arkansas Heart Hosptial

Little Rock, Arkansas, United States

Scripps Health

La Jolla, California, United States

Sequoia Hospital

Redwood City, California, United States

South Denver Cardiology Associates

Littleton, Colorado, United States

Florida Hospital

Orlando, Florida, United States

Emory University Hosptial

Atlanta, Georgia, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Bryan Heart

Lincoln, Nebraska, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

New York University Hospital

New York, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia

Austin, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Melbourne Hospital - City Campus

Parkville, Victoria, Australia

Countries

United States; Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10239

Identifier Type: -

Identifier Source: org_study_id