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

Launched by UNIVERSITY OF LEIPZIG · Nov 12, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at two different approaches for treating patients with atrial fibrillation (AF), a common heart rhythm problem. The main focus is to compare the usual treatment called pulmonary vein isolation (PVI) with a "sham" procedure, which mimics PVI but does not involve the actual treatment. The goal is to see if the improvement in symptoms that patients feel after PVI is genuine or if it could be a result of a placebo effect, meaning that people feel better simply because they believe they are receiving treatment.

To participate in this trial, you need to be at least 18 years old and have symptoms related to atrial fibrillation. You should also be scheduled for the PVI procedure based on current medical guidelines. However, if you've had previous heart procedures for AF or have certain medical conditions, you may not be eligible. If you choose to participate, you will be randomly assigned to receive either the real treatment or the sham procedure, and the study will closely monitor your symptoms and quality of life over time. This trial is currently recruiting participants, so if you or someone you know is interested, please talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with symptomatic atrial fibrillation scheduled for pulmonary vein isolation
• • 2. Class I or class IIa indication for pulmonary vein isolation by current guidelines
• • 3. Age ≥ 18 years
• • 4. Written informed consent
• Exclusion Criteria:
• • 1. History of previous pulmonary vein isolation or surgical treatment of atrial fibrillation
• • 2. Reversible causes of atrial fibrillation (e. g. thyroid disorder, acute alcohol intoxication, recent major surgical procedures, trauma or acute infection)
• • 3. Moderate or severe valvular heart disease
• • 4. CHA2DS2-VASc-Score =0 (males) or 1 (females) or contraindication to oral anticoagulation
• • 5. Acute coronary syndrome, percutaneous coronary intervention, valve surgery or percutaneous intervention or cardiac bypass surgery and stroke within the last 3 months
• • 6. Reduced left ventricular ejection fraction \< 35%
• • 7. Hypertrophic obstructive cardiomyopathy
• • 8. Medical conditions limiting the expected survival to \< 1 year
• • 9. Participation in any other randomized controlled trial
• • 10. 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
• • 11. 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)
• • 12. Subjects under legal supervision or guardianship
• • 13. Unable to give informed consent