Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry (SWISS-AF-PVI))
February 17, 2025 updated by: University Hospital, Basel, Switzerland
Registry of patients with atrial fibrillation undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) to determine long-term success rates of catheter-based ablation of atrial fibrillation (pulmonary vein isolation) and to evaluate factors associated with long-term success of catheter-based ablation of atrial fibrillation (pulmonary vein isolation).
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael Kuehne, MD
- Phone Number: +41 61 328 74 71
- Email: michael.kuehne@usb.ch
Study Contact Backup
- Name: Gian Voellmin, MSc
- Phone Number: +41 61 556 52 96
- Email: gian.voellmin@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Cardiology/Electrophysiology, University Hospital Basel
-
Contact:
- Michael Kuehne, MD
- Phone Number: +41 61 328 74 71
- Email: michael.kuehne@usb.ch
-
Bern, Switzerland, 3010
- Recruiting
- University Hospital Bern
-
Contact:
- Hildegard Tanner, Prof. Dr. med.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
All patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation) at the hospital.
The projected duration of the study is open-end with no projected date of study end.
Approximately 150-200 patients per year will be included.
Description
Inclusion Criteria:
- patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Exclusion Criteria:
- Patients not able or willing to participate in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Time Frame: before catheter-based ablation of atrial fibrillation and 3, 6 and 12 months after catheter-based ablation of atrial fibrillation
|
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
|
before catheter-based ablation of atrial fibrillation and 3, 6 and 12 months after catheter-based ablation of atrial fibrillation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
morphologic changes of left cardiac atrium
Time Frame: before catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
|
echocardiography of left cardiac atrium
|
before catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
|
|
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Time Frame: 12 months after catheter-based ablation of atrial fibrillation and then at intervals of one year until 2035
|
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
|
12 months after catheter-based ablation of atrial fibrillation and then at intervals of one year until 2035
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
determination of factors associated with long-term success rates of catheter-based ablation of atrial fibrillation
Time Frame: Blood samples gained during catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
|
Blood samples (biobanking) for determination of factors associated with long-term success rates of catheter-based ablation of atrial fibrillation (pulmonary vein isolation).
Decisions about future analyses to be performed from stored samples will be based exclusively on scientific reasons.
|
Blood samples gained during catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Kuehne, MD, Cardiology/Electrophysiology, University Hospital Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2010
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Study Registration Dates
First Submitted
October 23, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 17, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-00226; me18Kuehne2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.