Clinical trial NCT04356040: TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Official title: Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants With Device or Procedure-related Serious Adverse Events
timeFrame: Through 12 months
measure: KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
timeFrame: Through 12 months
Secondary outcomes:
measure: KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
timeFrame: Through 12 months
measure: KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure
timeFrame: 12 months
measure: KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs
timeFrame: Through 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Affinity Cardiovascular Specialists, LLC
state: Alabama
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Burlingame
country: United States
facility: Mills-Peninsula Medical Center
state: California
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Athens
country: United States
facility: Piedmont Athens Regional Medical Center
state: Georgia
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Coeur d'Alene
country: United States
facility: Kootenai Heart Clinics
state: Idaho
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: New York-Presbyterian/Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Tacoma
country: United States
facility: Franciscan Heart & Vascular Associates
state: Washington
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: Wesley Private Hospital
state: Queensl
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensl
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victori
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Linz
country: Austria
facility: A. ö. Krankenhaus der Elisabethinen Linz
state: Upr Aus
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Prague
country: Czechia
facility: IKEM Prague
state: Cbohmia
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabetes Zentrum NRW
state: N. Rhin
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Hong Ko
city: Milano
country: Italy
facility: Ospedale San Raffaele
state: Lombard
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Thoraxcenter
state: S Holln
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital (VGH)
state: Ntaiwan
Study officials:
affiliation: Clinical Program Director
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: