Status:
UNKNOWN
Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences
Lead Sponsor:
Cardioangiologisches Centrum Bethanien
Collaborating Sponsors:
Medtronic
CRO Kottmann
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The aim of the study is to evaluate different ablation strategies in patients with AF recurrences despite chronic PVI after prior catheter ablation. The present study is a multi-centre prospective ra...
Eligibility Criteria
Inclusion
- • Symptomatic non-valvular atrial fibrillation despite prior ablation with an indication for re-ablation according to current guidelines.
- Permanent pulmonary vein isolation according to mapping with a spiral mapping catheter
- Age 18-85 years.
- Left atrial size \< 55mm.
- Left ventricular ejection fraction ≥ 45%.
- Patient is able to provide informed consent and is willing to comply with the study protocol.
Exclusion
- Contraindications for repeat ablation
- Reconnected pulmonary veins according to mapping results with a spiral mapping catheter
- Minimal diameter of LAA neck ≥25mm
- History of mitral valve surgery
- Severe mitral valve regurgitation
- Inability to be treated with oral anticoagulation
- Presence of intracardiac thrombi
- Chronic obstructive pulmonary disease treated with long acting bronchodilatators
- Asthma
- Obstructive sleep apnea syndrome
- Pregnancy
- Participation in other clinical studies
- Unwilling to follow the study protocol and to attend follow-up visits
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2025
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT04056390
Start Date
August 1 2019
End Date
February 15 2025
Last Update
November 14 2023
Active Locations (7)
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1
Klinik für Elektrophysiologie/Rhythmologie - Herz- und Diabeteszentrum NRW - Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, Germany, 32545
2
Universitätsklinikum Köln
Cologne, Germany, 50937
3
Cardioangiologisches Centrum Bethanien
Frankfurt am Main, Germany, 60431
4
Universitätsmedizin Greifswald
Greifswald, Germany, 17475