Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry (SWISS-AF-PVI))

January 12, 2024 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

Conditions

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

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Cardiology/Electrophysiology, University Hospital Basel
        • Contact:
      • 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.

Sponsor

University Hospital, Basel, Switzerland

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.

General Publications

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 (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

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.

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