TactiFlex Paroxysmal Atrial Fibrillation IDE Trial

NCT04356040 | Completed Results DMC FDA Device

• 2 other identifiers: ABT-CIP-10303CRD_978
• Study Type: interventional
• Target: 355
• Locations: 9 countries
• Sites: 40

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).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Device or Procedure-related Serious Adverse Events

  Tthe rate of device and/or procedure-related serious adverse events with onset within 7-days of any ablation procedure that uses the TactiFlex SE catheter (initial or repeat procedure performed 31-80 days of initial procedure) that are defined below: * Atrio-esophageal fistula1 * Cardiac tamponade/perforation1 * Death * Heart block * Myocardial infarction * Pericarditis * Phrenic nerve injury resulting in diaphragmatic paralysis * Pulmonary edema * Pulmonary vein stenosis1 * Stroke/cerebrovascular accident * Thromboembolism * Transient ischemic attack * Vagal nerve injury/gastroparesis * Vascular access complications (including major bleeding events) 1. Atrio-esophageal fistula, cardiac tamponade/perforation and pulmonary vein stenosis will be evaluated through 12-months.

  Through 12 months

• KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence

  Freedom from documented (symptomatic or asymptomatic) Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia episodes of \>30 seconds duration that are documented by 12-lead ECG, transtelephonic monitoring or Holter monitor after the initial catheter ablation procedure through 12-months of follow-up. Recurrence during the 90-day blanking period will not be considered a treatment failure. One repeat procedure will be allowed during the blanking period. Failure to achieve acute procedural success during the last ablation procedure with the TactiFlex SE catheter will constitute failure. After the 90-day blanking period, use of Class I or III anti-arrhythmic drugs will not count as a therapy failure provided that only previously failed drugs are taken at doses that do not exceed the previously failed dose.

  Through 12 months

Secondary Outcomes (3)

• KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence

  Through 12 months

• KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure

  12 months

• KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs

  Through 12 months

Study Arms (2)

Main Study

EXPERIMENTAL

Device: TactiFlex SE

High Standard Power Sub-Study

EXPERIMENTAL

Device: TactiFlex SE - High Standard Power

Interventions

TactiFlex SE 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.

Also known as: TactiFlex Sensor Enabled Ablation Catheter

Main Study

TactiFlex SE - High Standard Power 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.

High Standard Power Sub-Study

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

A patient will be eligible for clinical trial participation if he/she meets the following 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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (45)

Affinity Cardiovascular Specialists, LLC

Birmingham, Alabama, 35243, United States

Location

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Mills-Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

AdventHealth Orlando

Orlando, Florida, 32806, United States

Location

Piedmont Athens Regional Medical Center

Athens, Georgia, 30309, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Kootenai Heart Clinics

Coeur d'Alene, Idaho, 83814, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Providence Hospital

Southfield, Michigan, 48075, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77380, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75204, United States

Location

Franciscan Heart & Vascular Associates

Tacoma, Washington, 98405, United States

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Wesley Private Hospital

Auchenflower, Queensl, 4066, Australia

Location

The Prince Charles Hospital

Chermside, Queensl, 4032, Australia

Location

Monash Medical Centre

Clayton, Victori, 3168, Australia

Location

Royal Adelaide Hospital

Adelaide, 5067, Australia

Location

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, 4020, Austria

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

IKEM Prague

Prague, Cbohmia, 14021, Czechia

Location

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, N. RHIN, 32545, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 4289, Germany

Location

Prince of Wales Hospital

Hong Kong, HONG KO, Hong Kong

Location

Ospedale San Raffaele

Milan, Lombard, 20132, Italy

Location

Erasmus MC - Thoraxcenter

Rotterdam, S Holln, 3015, Netherlands

Location

Taipei Veterans General Hospital (VGH)

Taipei, Ntaiwan, 11217, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anne Sarver
• Organization: Abbott

anne.sarver@abbott.com

6517563813

Study Officials

• Kristin Ruffner, PhD

  Clinical Program Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 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 Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 21, 2020
• Study Start: June 29, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: October 31, 2023
• Results First Posted: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); TW (1); AU (1); US (30); CA (2); CZ (1); IT (1); NL (1); DE (2)