Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF (NCT05119231) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF
Germany, Poland262 participantsStarted 2021-11-12
Plain-language summary
Being the most common arrhythmia, atrial fibrillation (AF) is a high burden of public health with an increasing prevalence in our aging population. Interventional treatment of atrial fibrillation by catheter ablation is one of the treatment pillars in the complex field of "better symptom control" based on current Guidelines. Catheter ablation of atrial fibrillation is based on electrical isolation of the pulmonary veins (pulmonary vein isolation: PVI) from the left atrium. The main benefit and goal of PVI in AF patients is the reduction of AF-related symptoms, resulting in an improvement of quality of life. It was shown, that catheter ablation failed to prove a difference in AF recurrence after PVI compared to medical therapy in the first 18 month of follow-up. It was also shown, that these episodes will become more asymptomatic. This raises concerns that the symptomatic improvement might be the result of a placebo effect, which will be elucidated with this study.
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
. Patients with symptomatic atrial fibrillation scheduled for pulmonary vein isolation
. Class I or class IIa indication for pulmonary vein isolation by current guidelines
. Age ≥ 18 years
. Written informed consent
Exclusion criteria
. History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation
. Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection)
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
difference of AFEQT sum scores evaluated at 6 months
Timeframe: 6 months after randomisation compared to baseline
. CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation
. Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months
. Reduced left ventricular ejection fraction \< 35%
. Hypertrophic obstructive cardiomyopathy
. Medical conditions limiting the expected survival to \< 1 year