N/A
N=355
TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04356040 ↗Enrolled (actual)
355
Serious AEs
21.9%
Results posted
Oct 2023
Primary outcome: Primary: Number of Participants With Device or Procedure-related Serious Adverse Events — 12; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TactiFlex SE (Device); TactiFlex SE - High Standard Power (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Device or Procedure-related Serious Adverse Events |
12; 2 | — |
| PRIMARY KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence |
72.9; 71.8 | — |
| SECONDARY KM Rate of Freedom From Symptomatic Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence |
80.4; 75.9 | — |
| SECONDARY KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence With Only 1 Ablation Procedure |
71.5; 71.8 | — |
| SECONDARY KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence, Without Anti-arrhythmic Drugs |
64.0; 65.8 | — |
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).
Eligibility Criteria
A patient will be eligible for clinical trial participation if he/she meets the following criteria:
- Plans to undergo a catheter ablation procedure due to symptomatic paroxysmal atrial fibrillation
- Physician's note indicating recurrent self-terminating atrial fibrillation
- 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.
- At least 18 years of age
- Able and willing to comply with all trial requirements
- 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:
- Persistent or long-standing persistent atrial fibrillation
- Active systemic infection
- Known presence of cardiac thrombus
- Hypertrophic cardiomyopathy
- Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the 90-day period preceding procedure
- Myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass grafting surgery within 90 days of procedure
- Left atrial diameter > 5.0 cm measured within 180 days of procedure (echocardiography or computerized tomography)
- Left ventricular ejection fraction 40 kg/m2
- 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.
- Individuals without legal authority
- Individuals unable to read or write
- Patients who have had a ventriculotomy or atriotomy within the preceding 4 weeks of procedure,
- Patients with prosthetic valves,
- Patients with a myxoma,
- Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
- Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
- Stroke or transient ischemic attack within the last 90 days
- Stent, constriction, or stenosis in a pulmonary vein.
- Rheumatic heart disease
- Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
Data sourced from ClinicalTrials.gov (NCT04356040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.