Persistent Atrial Fibrillation study: PFA
Official title PVI Alone Versus PVI Plus PWI and SVCI With PFA
ClinicalTrials.gov ID: NCT07405359
What this study is testing
- Who it's for
- People with persistent atrial fibrillation (a type of irregular heartbeat that lasts longer than 7 days).
- What's involved
- Participants will have a catheter ablation procedure to block heart signals. Some will get the standard treatment alone, while others will get extra blocking of the heart's back wall and top vein.
- Time commitment
- The study follows participants for one year to check if their heart rhythm stays normal.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years at their pre-procedure visit
- Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs\>7...
- Indicated and interested in ICM implant for monitoring post ablation
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
You likely can't join if
- Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
- Stroke or transient ischemic attack within the previous six months
- Gastrointestinal bleeding within the previous three months
- Implanted pacemaker or defibrillator
- Longstanding persistent AF (\> 3 years)
- LA volume \>80ml/m2
See the full eligibility criteria
- Age ≥18 years at their pre-procedure visit
- Persistent AF, defined as at least one continuous AF episode lasting at least seven days in duration, documented by a continuous monitor or 2 ECGs\>7 days apart or ≥3 cardioversions
- Indicated and interested in ICM implant for monitoring post ablation
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study
- Any prior atrial endocardial or epicardial ablation procedure, other than cavotricuspid isthmus ablation or supraventricular tachycardia
- Stroke or transient ischemic attack within the previous six months
- Gastrointestinal bleeding within the previous three months
- Implanted pacemaker or defibrillator
- Longstanding persistent AF (\> 3 years)
- LA volume \>80ml/m2
- Atrial septal occlusion device
- Current left atrial thrombus
- Left atrial appendage occlusion or closure device \< 6 mos or with leak or prior DRT
- Mitral or Tricuspid valve clip or mechanical replacement or clip
- Hypertrophic cardiomyopathy
- Contraindication to femoral vascular access
- Congenital heart disease with residual anatomic abnormality
- Contraindication to, or unwillingness to use, systemic anticoagulation
- Pregnancy
- Left ventricular ejection fraction \<30%
- Baseline creatinine \>2.0 mg/dL
- Predicted life expectancy less than one year
- Refusal to receive ICM implant or allergy to ICM
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.