NCT05119231Active, not recruiting
Pulmonary Vein Isolation vs SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With AF
Pulmonary Vein Isolation Versus SHAM-pulmonary Vein Isolation for Symptomatic Relief in Patients With Atrial Fibrillation- a Randomised Trial - PVI-SHAM-AF
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 262 (actual)
- First submitted
- 3 Nov 2021
- Start date
- 12 Nov 2021
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- University of Leipzig
- Diseases
- Atrial fibrillation
- NCT number
- NCT05119231
What you commit to
- Study type: Interventional
- Participants enrolled: 262
- From 12 Nov 2021 to the primary completion date, 1 Jun 2026
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation
Other illness
- 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
- Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months
- Medical conditions limiting the expected survival to \< 1 year
- 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)
Lab values
- Reduced left ventricular ejection fraction \< 35%
Other
- CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation
- Hypertrophic obstructive cardiomyopathy
- 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
- Subjects under legal supervision or guardianship
- Unable to give informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| German Heart Center of Charité University Medicine, Standort Charité Mitte Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| German Heart Center of Charité University Medicine, Standort DHZB Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Regiomed Klinikum Coordinator of this site? Confirm its status | Coburg | Germany | Unknown status |
| Heart Center Dresden University Hospital Coordinator of this site? Confirm its status | Dresden | Germany | Unknown status |
| University Hospital Gießen Coordinator of this site? Confirm its status | Giessen | Germany | Unknown status |
| Universitatsklinikum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Herzzentrum Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Unknown status |
| Universitätsklinikum Münster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
| Department of Cardiology, Silesian Center for Heart Diseases Coordinator of this site? Confirm its status | Zabrze | Poland | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.