TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

NCT ID: NCT04356040

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2022-07-01

Brief Summary

Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Detailed Description

This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for treating drug-refractory, symptomatic paroxysmal atrial fibrillation. This clinical investigation will be conducted under an investigational device exemption and is intended to support market approval of the TactiFlex SE catheter worldwide. Three hundred and Fifty Five (355) subjects will be enrolled at up to 50 investigational sites worldwide. This clinical investigation is sponsored by Abbott.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Main Study

Group Type: EXPERIMENTAL

TactiFlex SE

Intervention Type: DEVICE

Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.

High Standard Power Sub-Study

Group Type: EXPERIMENTAL

TactiFlex SE - High Standard Power

Intervention Type: DEVICE

Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.

Interventions

TactiFlex SE

Radiofrequency ablation with the TactiFlex SE ablation catheter. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.

Intervention Type: DEVICE

TactiFlex SE - High Standard Power

Radiofrequency ablation with the TactiFlex SE ablation catheter. Subjects in the High Standard Power Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.

Intervention Type: DEVICE

Other Intervention Names

TactiFlex Sensor Enabled Ablation Catheter

Eligibility Criteria

Inclusion Criteria

1. Plans to undergo a catheter ablation procedure due to symptomatic paroxysmal atrial fibrillation

2. Physician's note indicating recurrent self-terminating atrial fibrillation

3. One electrocardiographically documented atrial fibrillation episode within 12-months prior to informed consent/enrollment. Documented evidence of the atrial fibrillation episode must either be continuous atrial fibrillation on a 12-lead ECG or include at least 30 seconds of atrial fibrillation from another ECG device.

4. At least 18 years of age

5. Able and willing to comply with all trial requirements

6. Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical trial site.

A patient will be excluded from enrollment in the clinical trial if he/she meets any of the following criteria:

1. Persistent or long-standing persistent atrial fibrillation

2. Active systemic infection

3. Known presence of cardiac thrombus

4. Hypertrophic cardiomyopathy

5. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the 90-day period preceding procedure

6. Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass grafting surgery within 90 days of procedure

7. Left atrial diameter > 5.0 cm measured within 180 days of procedure (echocardiography or computerized tomography)

8. Left ventricular ejection fraction < 35% measured within 180 days of procedure (echocardiography or computerized tomography)

9. New York Heart Association class III or IV

10. Previous left atrial surgical or catheter ablation procedure

11. Left atrial surgical procedure or incision with resulting scar (including left atrial appendage closure device)

12. Previous tricuspid or mitral valve replacement or repair

13. Heart disease in which corrective surgery is anticipated within 180 days after the procedure

14. Bleeding diathesis or suspected pro-coagulant state

15. Contraindication to long term anti-thromboembolic therapy

16. Presence of any condition that precludes appropriate vascular access

17. Renal failure requiring dialysis

18. Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication

19. Severe 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 severe chronic symptoms

20. Women who are pregnant or breastfeeding

21. Presence of other anatomic or comorbid condition that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results

22. Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial

23. Patient is unlikely to survive the protocol follow up period of 12-months after the procedure

24. Body mass index > 40 kg/m2

25. Presence of other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

26. Individuals without legal authority

27. Individuals unable to read or write

28. Patients who have had a ventriculotomy or atriotomy within the preceding 4 weeks of procedure,

29. Patients with prosthetic valves,

30. Patients with a myxoma,

31. Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt

32. Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation

33. Stroke or transient ischemic attack within the last 90 days

34. Stent, constriction, or stenosis in a pulmonary vein.

35. Rheumatic heart disease

36. Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Ruffner, PhD

Role: STUDY_DIRECTOR

Clinical Program Director

Locations

Affinity Cardiovascular Specialists, LLC

Birmingham, Alabama, United States

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

Scripps Health

La Jolla, California, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, United States

South Denver Cardiology Associates PC

Littleton, Colorado, United States

AdventHealth Orlando

Orlando, Florida, United States

Piedmont Athens Regional Medical Center

Athens, Georgia, United States

St. Luke's Regional Medical Center

Boise, Idaho, United States

Kootenai Heart Clinics

Coeur d'Alene, Idaho, United States

St. Vincent Hospital

Indianapolis, Indiana, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Providence Hospital

Southfield, Michigan, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

New York University Hospital

New York, New York, United States

New York-Presbyterian/Columbia University Medical Center

New York, New York, United States

NC Heart & Vascular Research

Raleigh, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Franciscan Heart & Vascular Associates

Tacoma, Washington, United States

Westmead Hospital

Westmead, New South Wales, Australia

Wesley Private Hospital

Auchenflower, Queensl, Australia

The Prince Charles Hospital

Chermside, Queensl, Australia

Monash Medical Centre

Clayton, Victori, Australia

Royal Adelaide Hospital

Adelaide, , Australia

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, Austria

Kingston General Hospital

Kingston, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

IKEM Prague

Prague, Cbohmia, Czechia

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, N. RHIN, Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Prince of Wales Hospital

Hong Kong, HONG KO, Hong Kong

Ospedale San Raffaele

Milan, Lombard, Italy

Erasmus MC - Thoraxcenter

Rotterdam, S Holln, Netherlands

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, Taiwan

Countries

United States; Australia; Austria; Canada; Czechia; Germany; Hong Kong; Italy; Netherlands; Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CRD_978

Identifier Type: OTHER

Identifier Source: secondary_id

ABT-CIP-10303

Identifier Type: -

Identifier Source: org_study_id