Comparing Pulmonary Vein Isolation and Sham Procedure for Atrial Fibrillation Relief
Pulmonary Vein Isolation Versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients with Atrial Fibrillation- a Randomised Trial - PVI-SHAM-AF
NA · University of Leipzig · NCT05119231
This study tests if a procedure that isolates the pulmonary veins can help people with atrial fibrillation feel better compared to a fake treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Leipzig (other) |
| Locations | 7 sites (Coburg, Bayern and 6 other locations) |
| Trial ID | NCT05119231 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of pulmonary vein isolation (PVI) compared to a sham procedure in patients with symptomatic atrial fibrillation (AF). PVI aims to electrically isolate the pulmonary veins to reduce AF-related symptoms and improve quality of life. The study will assess whether the symptomatic relief observed in patients undergoing PVI is due to the procedure itself or a placebo effect. Participants will be adults scheduled for PVI, and the study will include a control group receiving a sham treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptomatic atrial fibrillation who meet current guidelines for pulmonary vein isolation.
Not a fit: Patients with reversible causes of atrial fibrillation or significant comorbidities that limit their expected survival may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could clarify the true efficacy of pulmonary vein isolation in alleviating symptoms of atrial fibrillation, potentially leading to improved treatment protocols.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of pulmonary vein isolation, indicating that this investigation into the placebo effect is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with symptomatic atrial fibrillation scheduled for pulmonary vein isolation 2. Class I or class IIa indication for pulmonary vein isolation by current guidelines 3. Age ≥ 18 years 4. Written informed consent Exclusion Criteria: 1. History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation 2. Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection) 3. Moderate or severe valvular heart disease 4. CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation 5. Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months 6. Reduced left ventricular ejection fraction \< 35% 7. Hypertrophic obstructive cardiomyopathy 8. Medical conditions limiting the expected survival to \< 1 year 9. Participation in any other randomized controlled trial 10. Women of childbearing potential without appropriate contraceptive measures (oral contraceptives, vaginal ring, intrauterine devices, implanon, injections, partner with vasectomy) pregnant woman or woman with desire for children 11. Any condition that - in the opinion of the investigator - may prevent the subject from adhering to the study protocol (e.g. history of non-compliance, drug addiction) 12. Subjects under legal supervision or guardianship 13. Unable to give informed consent
Where this trial is running
Coburg, Bayern and 6 other locations
- Regiomed Klinikum — Coburg, Bayern, Germany (RECRUITING)
- University Hospital Gießen — Gießen, Hessen, Germany (RECRUITING)
- Universitätsklinikum Münster — Münster, Nordrhein-Westfalen, Germany (RECRUITING)
- Heart Center Dresden University Hospital — Dresden, Sachsen, Germany (RECRUITING)
- German Heart Center of Charité University Medicine — Berlin, Germany (RECRUITING)
- Herzzentrum Leipzig — Leipzig, Germany (RECRUITING)
- Universitätsklinikum Leipzig — Leipzig, Germany (RECRUITING)
Study contacts
- Study coordinator: Rolf Wachter, Prof. Dr.
- Email: rolf.wachter@medizin.uni-leipzig.de
- Phone: 00493419712650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Arrhythmias, Cardiac, Heart Disease, ECG Monitoring