Atrial Fibrillation study: PVI-PLUS ARM
Official title Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation
ClinicalTrials.gov ID: NCT04823299
What this study is testing
- What it's testing
- The trial wants to see if a personalized ablation that targets specific AF sources works better than the usual pulmonary vein isolation technique.
- Who it's for
- It is looking for adults who have paroxysmal atrial fibrillation and are candidates for catheter ablation.
- What's involved
- Participants will receive one of the two ablation procedures, then have their heart rhythm monitored continuously and will be followed up to check for AF recurrence and safety.
- Time commitment
- The study lasts until the final follow‑up visit, which may be several months after the procedure, with scheduled clinic visits and rhythm monitoring during that time.
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 on the date of consent for the trial.
- people must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy...
- people must be able to provide informed consent.
You likely can't join if
- Persistent and permanent AF.
- History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant...
- Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial.
- Previous left atrial (LA) ablation or LA surgery.
- Previous pulmonary vein stenosis or pulmonary vein stent.
- Pre-existing hemi-diaphragmatic paralysis.
See the full eligibility criteria
- Age ≥18 years on the date of consent for the trial.
- people must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion).
- people must be able to provide informed consent.
- Persistent and permanent AF.
- History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (AVRT).
- Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial.
- Previous left atrial (LA) ablation or LA surgery.
- Previous pulmonary vein stenosis or pulmonary vein stent.
- Pre-existing hemi-diaphragmatic paralysis.
- Active intracardiac thrombus.
- Contraindication to systemic oral anticoagulation therapy
- Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following...
- Reversible causes of AF (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery).
- Left ventricular ejection fraction \<35%.
- NYHA Class 4 heart failure.
- Hypertrophic cardiomyopathy
- Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
- Patients with mechanical mitral prosthetic valves
- Known adverse reaction to adenosine.
- Chronic Kidney Disease ≥ Stage 4.
- Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, people with patent foramen ovale will not be excluded).
- Pregnant people.
- Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial.
- History of thromboembolic events in the 6 months preceding enrollment.
- Currently participating or anticipated to participate in treatment clinical trials of drug, device or biologic agents that could affect the results of this trial.
- Primary pulmonary hypertension
- Rheumatic heart disease
- Thrombocytosis, thrombocytopenia and other hypercoagulable states
- Active systemic infection
- Patients with life expectancy less than 12 months.
- Unwilling or unable to comply fully with study procedures and follow-up.
The study team makes the final eligibility decision.
Where it is enrolling
- Ottawa, Ontario, Canada
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 Ottawa, Ontario, Canada. 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.