Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

Biotronik

Status: Terminated

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Other: Paperbased neurocognitive testing; Device: Transesophageal Echocardiography; Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02275260

EP025

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

All patients

Experimental group

Description:

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

Treatment:

Device: Transesophageal Echocardiography

Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging

Other: Paperbased neurocognitive testing