Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

Study Overview
=================
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.

Official Title
-----------------
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)

Conditions
-----------------
Paroxysmal Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging
* Device: Transesophageal Echocardiography
* Other: Paperbased neurocognitive testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing | Device: Cerebral Diffusion-Weighted Magnetic Resonance Imaging<br>* Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)<br>* Other names: 1.5-3 T machine capable of Diffusion-Weighted MRI;Device: Transesophageal Echocardiography<br>* Patients undergo a Transesophageal Echocardiography prior to the ablation itself<br>* Other names: Any Transesophageal Echocardiography machine;Other: Paperbased neurocognitive testing<br>* To assess the impact of PVI on the patient's neurocognitive status<br>* Other names: STATE questionnaire, d2 test, visual VVM2, MOCA subtest;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic lesions | The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI | 1-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive status | 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 | Baseline, 1-3 days and 3 months | 
| Peri-procedural serious adverse events | Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure | Within 24 hours after ablation | 
| Post-procedural clinical TE events | 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) | 3 months period |