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

NCT05119231 | Active Not Recruiting DMC

• 1 other identifier: PVI-SHAM-AF CIV-21-01-035584
• Study Type: interventional
• Target: 262
• Locations: 2 countries
• Sites: 9

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Arrhythmias, Cardiac; Heart Disease; ECG Monitoring

Outcome Measures

Primary Outcomes (1)

• difference of AFEQT sum scores evaluated at 6 months

  The primary objective is to show a significant improvement of AF symptoms (measured by AFEQT sum score) by PVI in comparison to sham-PVI, evaluated six months after randomisation compared to baseline. Primary endpoint is the difference of AFEQT sum scores between the PVI and the sham-PVI arm, evaluated at 6 months after randomisation.

  6 months after randomisation compared to baseline

Secondary Outcomes (8)

• the longitudinal change of the AFEQT score

  baseline - 3, 6 and 12 months

• difference of EQ-5D scores

  at 6 months to baseline

• difference of SF-36 scales

  at 6 months to baseline

• the change of EQ-5D over time (baseline - 3, 6 and 12 months) in a longitudinal view

  (baseline - 3, 6 and 12 months) in a longitudinal view

• the change of SF-36 over time

  baseline - 3, 6 and 12 months

Study Arms (2)

Pulmonary Vein Isolation

EXPERIMENTAL

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.

Procedure: Pulmonary Vein Isolation

Sham Control Arm

SHAM COMPARATOR

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.

Other: Sham-Pulmonary Vein Isolation

Interventions

Pulmonary Vein Isolation PROCEDURE

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

Pulmonary Vein Isolation

Sham-Pulmonary Vein Isolation OTHER

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

Sham Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Moderate or severe valvular heart disease
• 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
• Participation in any other randomized controlled trial
• 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
• 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)
• Subjects under legal supervision or guardianship
• Unable to give informed consent

Sponsors & Collaborators

• University of Leipzig: lead

Study Sites (9)

Regiomed Klinikum

Coburg, Bavaria, 96450, Germany

Location

University Hospital Gießen

Giessen, Hesse, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Heart Center Dresden University Hospital

Dresden, Saxony, 01307, Germany

Location

German Heart Center of Charité University Medicine, Standort Charité Mitte

Berlin, State of Berlin, Germany

Location

German Heart Center of Charité University Medicine, Standort DHZB

Berlin, State of Berlin, Germany

Location

Herzzentrum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Department of Cardiology, Silesian Center for Heart Diseases

Zabrze, Poland

Location

Related Publications (1)

• Dilk P, Uhe T, Forkmann M, Eckardt L, Bode K, Seewoster T, Gaspar T, Neef M, Dinov B, Bacak M, Petroff D, Prettin C, Hindricks G, Laufs U, Dagres N, Wachter R. Pulmonary vein isolation versus SHAM-pulmonary vein isolation for symptomatic relief in patients with atrial fibrillation-Design and rationale of the PVI-SHAM-AF trial. Am Heart J. 2025 Dec;290:93-104. doi: 10.1016/j.ahj.2025.06.003. Epub 2025 Jun 11.

  PMID: 40513974 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Wachter, Prof. Dr.

  University of Leipzig

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, parallel group, sham-controlled and double-blinded multicenter trial

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: November 12, 2021
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: with publication of the major results
• Access Criteria: IPD will be made available upon reasonable request and if approved by the ethic´s committee.

Locations

DE (8); PL (1)