Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

Not Applicable

Terminated

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging; Device: Transesophageal Echocardiography; Other: Paperbased neurocognitive testing

• Registration Number: NCT02275260
• Lead Sponsor: Biotronik SE & Co. KG

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 thromboembolic lesions after Pulmonary Vein Isolation to historical data from the literature.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Study Start: 2014-12
• Primary Completion: 2017-02-08
• Study Completion: 2018-02-15
• Status Verified: 2018-05
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Transesophageal Echocardiography	All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
All patients	Paperbased neurocognitive testing	All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
All patients	Cerebral Diffusion-Weighted Magnetic Resonance Imaging	All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing

Primary Outcome Measures

Name	Time	Method
Thromboembolic lesions	1-3 days	The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI

Secondary Outcome Measures

Name	Time	Method
Neurocognitive status	Baseline, 1-3 days and 3 months	To assess the impact of PVI on the patient's neurocognitive status measured by a testing battery including the STATE questionnaire, d2 test of attention, visual part of the visual and verbal memory test (VVM2) and Montreal Cognitive Assessment (MOCA) subtest
Peri-procedural serious adverse events	Within 24 hours after ablation	Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure
Post-procedural clinical TE events	3 months period	Composite endpoint: Occurrence of Transient Ischemic Attack and/or Ischemic Stroke and/or Systemic Embolism during the three months post-ablation period (excluding peri-procedural events)

Trial Locations

Locations (14)

Hôpitaux Universitaires de Genève; 🇨🇭 Geneva, Switzerland

Semmelweis Medical University; 🇭🇺 Budapest, Hungary

Institute for Clinical and Experimental Medicine (IKEM); 🇨🇿 Prague, Czechia

Peter Osypka Herzzentrum München; 🇩🇪 Munich, Germany

Deutsches Herzzentrum München des Freistaates Bayern; 🇩🇪 Munich, Germany

Ceske Budejovice Hospital; 🇨🇿 Budweis, Czechia

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Charité Campus Virchow; 🇩🇪 Berlin, Germany

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

OLVG - Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Charité Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

Cardioangologisches Centrum Bethanien (CCB); 🇩🇪 Frankfurt/Main, Germany

Universität Leipzig; 🇩🇪 Leipzig, Germany

Haga Ziekenhuis; 🇳🇱 Den Haag, Netherlands