Catheter-based Ablation of Atrial FibrillationSWISS-AF-PVI)NCT03718364
Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry
An observational study of Catheter-based Ablation of Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-based Ablation of Atrial Fibrillation
- What is being tested?
- catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jul 2010to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Who cannot join
- Patients not able or willing to participate in this study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Cardiology/Electrophysiology, University Hospital Basel
Basel, 4031
Michael Kuehne, MD, +41 61 328 74 71, michael.kuehne@usb.ch
- Recruiting
University Hospital Bern
Bern, 3010
Hildegard Tanner, Prof. Dr. med.
About this study
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).
- Being tested
- catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
- Keywords
- atrial fibrillation, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheter-based ablation of atrial fibrillation (pulmonary vein isolation)Procedure or surgery
catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in retention rate of normal sinus rhythm after 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)
Measured: before catheter-based ablation of atrial fibrillation and 3, 6 and 12 months after catheter-based ablation of atrial fibrillation
Secondary outcomes (2)
morphologic changes of left cardiac atrium
echocardiography of left cardiac atrium
Measured: 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)
changes in retention rate of normal sinus rhythm after catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Measured: 12 months after catheter-based ablation of atrial fibrillation and then at intervals of one year until 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Jul 2010
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Catheter-based Ablation of Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Kuehne, MD, Principal investigator, Cardiology/Electrophysiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718364
- Sponsor's protocol ID
- 2018-00226; me18Kuehne2
- Other IDs
- 2018
- Acronym
- SWISS-AF-PVI)
- Status last verified
- Feb 2025
- First submitted
- 23 Oct 2018
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bruss J, Kueffer T, Tanner H, Noti F, Haeberlin A, Thalmann G, Kozhuharov NA, Kovacs B, Spahiu V, Siklody CH, Reichlin T, Roten L. NT-proBNP as a Predictor of Atrial Fibrillation Recurrence After Cryoballoon, Radiofrequency and Pulsed-Field Ablation. Pacing Clin Electrophysiol. 2026 Apr 3. doi: 10.1111/pace.70237. Online ahead of print.
PubMed 41930479Stauffer N, Knecht S, Badertscher P, Krisai P, Hennings E, Serban T, Voellmin G, Osswald S, Sticherling C, Kuhne M. Repeat catheter ablation after very late recurrence of atrial fibrillation after pulmonary vein isolation. Europace. 2024 May 2;26(5):euae096. doi: 10.1093/europace/euae096.
PubMed 38607938Hennings E, Aeschbacher S, Coslovsky M, Paladini RE, Meyre PB, Voellmin G, Blum L, Kastner P, Ziegler A, Conen D, Zuern CS, Krisai P, Badertscher P, Sticherling C, Osswald S, Knecht S, Kuhne M. Association of bone morphogenetic protein 10 and recurrent atrial fibrillation after catheter ablation. Europace. 2023 Jun 2;25(6):euad149. doi: 10.1093/europace/euad149.
PubMed 37314197Meyre PB, Sticherling C, Spies F, Aeschbacher S, Blum S, Voellmin G, Madaffari A, Conen D, Osswald S, Kuhne M, Knecht S. C-reactive protein for prediction of atrial fibrillation recurrence after catheter ablation. BMC Cardiovasc Disord. 2020 Sep 29;20(1):427. doi: 10.1186/s12872-020-01711-x.
PubMed 32993521
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Atrial Fibrillation Pulmonary Vein Isolation Registry
- ClinicalTrials.gov ID
- NCT03718364
- Acronym / sponsor ID
- SWISS-AF-PVI) / 2018-00226; me18Kuehne2
- Keywords
- atrial fibrillation, pulmonary vein isolation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients undergoing catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
Key exclusion criteria (1 listed)
- Patients not able or willing to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheter-based ablation of atrial fibrillation (pulmonary vein isolation)catheter-based ablation of atrial fibrillation (pulmonary vein isolation) | Procedure or surgery | – |
Primary outcome
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)
2 secondary outcomes
morphologic changes of left cardiac atrium
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Derived from this study: PubMed 41930479Bruss J, Kueffer T, Tanner H, Noti F, Haeberlin A, Thalmann G, Kozhuharov NA, Kovacs B, Spahiu V, Siklody CH, Reichlin T, Roten L. NT-proBNP as a Predictor of Atrial Fibrillation Recurrence After Cryoballoon, Radiofrequency and Pulsed-Field Ablation. Pacing Clin Electrophysiol. 2026 Apr 3. doi: 10.1111/pace.70237. Online ahead of print.
- Derived from this study: PubMed 38607938Stauffer N, Knecht S, Badertscher P, Krisai P, Hennings E, Serban T, Voellmin G, Osswald S, Sticherling C, Kuhne M. Repeat catheter ablation after very late recurrence of atrial fibrillation after pulmonary vein isolation. Europace. 2024 May 2;26(5):euae096. doi: 10.1093/europace/euae096.
- Derived from this study: PubMed 37314197Hennings E, Aeschbacher S, Coslovsky M, Paladini RE, Meyre PB, Voellmin G, Blum L, Kastner P, Ziegler A, Conen D, Zuern CS, Krisai P, Badertscher P, Sticherling C, Osswald S, Knecht S, Kuhne M. Association of bone morphogenetic protein 10 and recurrent atrial fibrillation after catheter ablation. Europace. 2023 Jun 2;25(6):euad149. doi: 10.1093/europace/euad149.
- Derived from this study: PubMed 32993521Meyre PB, Sticherling C, Spies F, Aeschbacher S, Blum S, Voellmin G, Madaffari A, Conen D, Osswald S, Kuhne M, Knecht S. C-reactive protein for prediction of atrial fibrillation recurrence after catheter ablation. BMC Cardiovasc Disord. 2020 Sep 29;20(1):427. doi: 10.1186/s12872-020-01711-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Kuehne, MD principal investigator
Cardiology/Electrophysiology, University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-based Ablation of Atrial Fibrillation, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Kuehne, MD (+41 61 328 74 71, michael.kuehne@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03718364, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.