TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
- Conditions
- Paroxysmal Atrial Fibrillation
- Interventions
- Device: TactiFlex SEDevice: TactiFlex SE - High Standard Power
- Registration Number
- NCT04356040
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Main Study TactiFlex SE - High Standard Power Sub-Study TactiFlex SE - High Standard Power -
- Primary Outcome Measures
Name Time Method Number of Participants With Device or Procedure-related Serious Adverse Events Through 12 months 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.KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence Through 12 months 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.
- Secondary Outcome Measures
Name Time Method KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence Through 12 months Freedom from documented symptomatic 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 (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. 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-arrhythmias drugs will not count as a therapy failure provided that only previously failed Class I or III anti-arrhythmias drugs are taken at doses that do not exceed the previously failed dose.
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure 12 months 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 (≤90 days post-initial procedure) will not be considered a treatment failure. Any repeat ablation procedure in the left atrium will be considered a treatment failure. Failure to achieve acute procedural success during the 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 Class I or III anti-arrhythmic drugs are taken at doses that do not exceed the previously failed dose.
KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs Through 12 months 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 (9 months after a 90-day blanking period). Recurrence during the 90-day blanking period (≤90 days post-initial procedure) will not be considered a treatment failure. One repeat procedure will be allowed for ablation 31-80 days after the initial procedure and will not be considered a treatment failure. 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, any use of a Class I or III anti-arrhythmic drugs will count as an effectiveness failure.
Trial Locations
- Locations (45)
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸San Diego, California, United States
A. ö. Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Upr Aus, Austria
Taipei Veterans General Hospital (VGH)
🇨🇳Taipei, Ntaiwan, Taiwan
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
Mills-Peninsula Medical Center
🇺🇸Burlingame, California, United States
St. Bernards Medical Center
🇺🇸Jonesboro, Arkansas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Scripps Health
🇺🇸La Jolla, California, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Kansas City Cardiac Arrhythmia Research Foundation
🇺🇸Overland Park, Kansas, 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
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Franciscan Heart & Vascular Associates
🇺🇸Tacoma, Washington, United States
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Wesley Private Hospital
🇦🇺Auchenflower, Queensl, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Monash Medical Centre
🇦🇺Clayton, Victori, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensl, Australia
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
Ospedale San Raffaele
🇮🇹Milano, Lombard, Italy
Erasmus MC - Thoraxcenter
🇳🇱Rotterdam, S Holln, Netherlands
Affinity Cardiovascular Specialists, LLC
🇺🇸Birmingham, Alabama, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Kootenai Heart Clinics
🇺🇸Coeur d'Alene, Idaho, United States
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Ko, Hong Kong