Pulmonary Vein Isolation Versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With Atrial Fibrillation- a Randomised Trial - PVI-SHAM-AF

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
German Heart Center of Charité University Medicine
RECRUITING
Berlin
Regiomed Klinikum
RECRUITING
Coburg
Heart Center Dresden University Hospital
RECRUITING
Dresden
University Hospital Gießen
RECRUITING
Giessen
Herzzentrum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Münster
RECRUITING
Münster
Contact Information
Primary
Rolf Wachter, Prof. Dr.
rolf.wachter@medizin.uni-leipzig.de
00493419712650
Backup
Nikolaos Dagres, PD Dr.
nikolaos.dagres@dhzc-charite.de
0049-30-450565407
Time Frame
Start Date: 2021-11-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 260
Treatments
Experimental: Pulmonary Vein Isolation
Pulmonary Vein Isolation (radiofrequency ablation or cryoablation) of atrial fibrillation according to local standards:~Trial participants will assigned to the PVI-arm will undergo catheter ablation within 48 hours after baseline evaluation, with the aim to achieve isolation of all pulmonary veins and restore sinus rhythm.~Dependent of the local standards an echocardiography or cardiac MRI will be performed prior to the procedure. If necessary, a transesophageal echocardiography must be performed to exclude presence of atrial thrombus.~Anticoagulation will be initiated/continued for at least 3 months after the procedure.
Sham_comparator: Sham Control Arm
Sham Pulmonary Vein Isolation~Trial participants will assigned to the SHAM-arm will undergo their procedure within 48 hours after baseline evaluation. The Sham procedure will include deep sedation according to the respective PVI protocol for at least one hour, femoral vein/artery puncture with introduction of sheaths and an electrical cardioversion in presence of persistent atrial fibrillation.~Dependent of the local standards an echocardiography or cardiac MRI will be performed prior to the procedure. If necessary, a transesophageal echocardiography must be performed to exclude presence of atrial thrombus.~Anticoagulation will be initiated/continued for at least 3 months after the procedure.
Related Therapeutic Areas
Sponsors
Leads: University of Leipzig

This content was sourced from clinicaltrials.gov