An observational study in Atrial Fibrillation (AF), sponsored by Texas Cardiac Arrhythmia Research Foundation. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-17.
Sponsored by Texas Cardiac Arrhythmia Research Foundation · Observational
This study is designed to directly compare the safety and efficacy of PFA-based PVI+PWI vs PFA-based PVI+ VoM alcohol ablation in patients with Persistent AF.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 162 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Persistent atrial fibrillation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Previous PWI or VoM ablation procedure
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PVI: General periprocedural guidance includes target activated clotting time (ACT) ≥350, catheter exchange ≤2, \>10s spacing of consecutive applications, and minimization of number of PF applications per the recommended procedures below: For each pulmonary vein, a concentric ring of applications will be created using 12 (6 ostial and 6 antral) applications In case of visual gaps, additional 8 applications will be added PWI: Concentric overlapping ablations will be placed throughout the posterior wall deliberately. The catheter will be rotated once between a pair of applications; briefly, rotation is performed such that, post-rotation, the splines are situated midway between the splines' pre- rotation positions. The number of applications will be at the operator's discretion. VoM: VoM alcohol ablation procedure will be conducted before the catheter ablation. VoM will be visualized by coronary sinus venography, cannulated with an angioplasty wire and balloon and 1 cc of 98% ethanol will
PVI: General periprocedural guidance includes target activated clotting time (ACT) ≥350, catheter exchange ≤2, \>10s spacing of consecutive applications, and minimization of number of PF applications per the recommended procedures below: For each pulmonary vein, a concentric ring of applications will be created using 12 (6 ostial and 6 antral) applications In case of visual gaps, additional 8 applications will be added PWI: Concentric overlapping ablations will be placed throughout the posterior wall deliberately. The catheter will be rotated once between a pair of applications; briefly, rotation is performed such that, post-rotation, the splines are situated midway between the splines' pre- rotation positions. The number of applications will be at the operator's discretion.
Recurrence of atrial arrhythmia: any episode of AF/AT longer than 30 sec off-AAD, after the 2-month blanking period
Time frame: 1 year
• Arrhythmia-free on previously ineffective AAD without any dose-escalation
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Yes — In order to protect the privacy of the patients, only analyzed data will be shared for research purpose, at the discretion of the PI
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for May 2027, 24 months later.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 24 months is below that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Texas Cardiac Arrhythmia Research Foundation