Status:
TERMINATED
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
Lead Sponsor:
Biotronik SE & Co. KG
Collaborating Sponsors:
University Hospital Heidelberg
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The REDUCE-TE Pilot study is an international, multicenter, prospective, single arm study to compare the AlCath Flux eXtra Gold ablation catheter regarding the prevention of new subclinical cerebral t...
Eligibility Criteria
Inclusion
- Electrocardiographically documented, symptomatic paroxysmal AF.
- Patients with indication for left atrial ablation of AF according to ESC guidelines for the management of atrial fibrillation.
- Anticoagulation according to clinical routine using coumarin derivates with target INR between 2.0 and 3.0 at least 3 weeks prior to the scheduled ablation procedure or novel oral anticoagulants (NOACs).
- Geographically stable for the duration of the study.
- Willingness and ability to perform written informed consent
Exclusion
- Long standing persistent or persistent AF
- CHA2DS2-VASc score ≥ 5
- Prior ischemic stroke or Transient Ischemic Attack
- Previous Pulmonary Vein ablation
- Contraindication for anticoagulation therapy
- Contraindication for Diffusion-Weighted MRI
- Claustrophobia
- Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE, if TEE not possible)
- Implanted cardiovascular device, including but not limited to an atrial or ventricular pacemaker or defibrillator leads, artificial valves, stents, septal or LAA occluders
- Acute coronary syndrome \< 3 months prior to scheduled ablation
- Moderate to severe valvular heart disease
- LA size \> 55 mm (confirming echo at maximum 3 months old)
- Patients with non-controlled heart failure or patients with current and recent (\< 1 month prior to ablation) heart failure
- Ejection fraction \< 35% (confirming echo at maximum 3 months old)
- Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion)
- Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
- Any limitation to contractual capability
- Simultaneous participation in another study
- Age \< 18 years
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2018
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02275260
Start Date
December 1 2014
End Date
February 15 2018
Last Update
November 1 2019
Active Locations (14)
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1
Ceske Budejovice Hospital
České Budějovice, Czechia
2
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia
3
Kerckhoff-Klinik
Bad Nauheim, Germany
4
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany