Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF
Sponsor: University of Leipzig
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.
Official title: Pulmonary Vein Isolation Versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With Atrial Fibrillation- a Randomised Trial - PVI-SHAM-AF
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2021-11-12
Completion Date
2026-11
Last Updated
2025-11-19
Healthy Volunteers
No
Conditions
Interventions
Pulmonary Vein Isolation
Catheter ablation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standard
Sham-Pulmonary Vein Isolation
Sham-Pulmonary Vein Isolation in deep sedation for at least one hour including femoral vein/artery puncture with introduction of sheaths and electrical cardioversion in presence of current atrial fibrillation
Locations (9)
Regiomed Klinikum
Coburg, Bavaria, Germany
University Hospital Gießen
Giessen, Hesse, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Heart Center Dresden University Hospital
Dresden, Saxony, Germany
German Heart Center of Charité University Medicine, Standort Charité Mitte
Berlin, State of Berlin, Germany
German Heart Center of Charité University Medicine, Standort DHZB
Berlin, State of Berlin, Germany
Herzzentrum Leipzig
Leipzig, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Department of Cardiology, Silesian Center for Heart Diseases
Zabrze, Poland