Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Per… (NCT03057548) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Pulmonary Vein Ablation With or Without Left Atrial Posterior Wall Ablation for Persistent AF (PIVoTAL)
United States, Japan110 participantsStarted 2017-02-24
Plain-language summary
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with ablation of the posterior left atrial wall (PLAW) will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with persistent or long-standing persistent AF one year after an ablation procedure in comparison to a PVI ablation procedure, alone.
The investigator hypothesizes that the combination of PVI plus PLAW isolation will result in a reduction in recurrence of atrial arrhythmias at one year after ablation.
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:
* Males and females with an age \>18 years undergoing a first-time catheter ablation of AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial flutter) is permitted
* All patients must understand the requirements of the study and be willing to comply with the post-study follow-up requirements
* Patients must be in AF on the day of the procedure
Exclusion Criteria:
* Any reversible cause of AF (post-operative, thyroid disorder, etc)
* Patients with cerebral ischemic events (stroke or transient ischemic attack), myocardial infarction or unstable angina in the previous 2 months
* Patients with any corrected or uncorrected congenital heart disease
* Patients with a history of hypertrophic cardiomyopathy
* Patients with cardiomyopathy and a left ventricular ejection fraction \<35%
* Congestive heart failure, class IV
* Women who are known to be pregnant or have had a positive β-Human Chorionic Gonadotropin (β-HCG) test 7 days prior to procedure
* Patients whose life expectancy is \<1 year
* History of left-sided left atrial ablation (catheter or surgically-based)
* Mental impairment precluding the patient from providing informed consent or completing appropriate follow-up
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.