A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF: (NCT06676072) | Clinical Trial Compass
CompletedNot Applicable
A Study of the TactiFlex SE Catheter and Volt PFA Generator in Subjects With PAF:
United States, Austria, Lithuania188 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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