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ACTIVE NOT RECRUITING
NCT05119231
NA

Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF

Sponsor: University of Leipzig

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Pulmonary Vein Isolation

Catheter ablation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standard

OTHER

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