A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF: (NCT06676072) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
United States188 participantsStarted 2024-11-22
Plain-language summary
The objective of this clinical study is to demonstrate that ablation with the TactiFlex SE Ablation catheter, in conjunction with a compatible pulsed field ablation (PFA) and/or radio frequency (RF) generator, is safe and effective for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation (PAF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Documented symptomatic paroxysmal atrial fibrillation (PAF). Documentation requirements are as follows:
✓. Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 6 months prior to enrollment AND
✓. One electrocardiographically documented PAF episode within 12 months prior to enrollment.
✓. Plans to undergo a catheter ablation procedure due to symptomatic PAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
✓. At least 18 years of age
✓. Able and willing to comply with all trial requirements including pre- procedure, post-procedure, and follow-up testing and 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 (IRB/EC) of the respective clinical trial site.
Exclusion criteria
✕. Previously diagnosed persistent or long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
✕. Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
✕. Known presence of cardiac thrombus
✕
What they're measuring
1
Proportion of subjects experiencing a device and/or procedure-related serious adverse event with onset within 7 days of any ablation procedure (index or repeat procedure performed 0-90 days post initial procedure).
Timeframe: 7 days
2
Freedom from documented (symptomatic or asymptomatic) AF/AFL/AT episodes of greater than 30 seconds duration that are documented by protocol-specified 12-lead ECG, TTM or Holter monitor (HM) devices after the index ablation procedure
. Left atrial diameter (LAD) \> or equal to 5.0 cm (anteroposterior diameter) within 180 days prior to the index procedure
✕. Left ventricular ejection fraction (LVEF) \< or equal to 35% as assessed with echocardiography or computerized tomography (CT) within 180 days prior to the index procedure
✕. New York Heart Association (NYHA) class III or IV heart failure