Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

October 30, 2019 updated by: Biotronik SE & Co. KG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Budweis, Czechia
        • Ceske Budejovice Hospital
      • Prague, Czechia
        • Institute for Clinical and Experimental Medicine (IKEM)
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff-klinik
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum NRW
      • Berlin, Germany
        • Charite Campus Benjamin Franklin
      • Berlin, Germany
        • Charite Campus Virchow
      • Frankfurt/Main, Germany
        • Cardioangologisches Centrum Bethanien (CCB)
      • Leipzig, Germany
        • Universität Leipzig
      • Munich, Germany
        • Deutsches Herzzentrum München des Freistaates Bayern
      • Munich, Germany
        • Peter Osypka Herzzentrum Munchen
  • Hungary
      • Budapest, Hungary
        • Semmelweis Medical University
  • Netherlands
      • Amsterdam, Netherlands
        • OLVG - Onze Lieve Vrouwe Gasthuis
      • Den Haag, Netherlands
        • Haga ziekenhuis
  • Switzerland
      • Geneva, Switzerland
        • Hôpitaux Universitaires de Genève

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
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
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
Other Names:
  • 1.5-3 T machine capable of Diffusion-Weighted MRI
Device: Transesophageal Echocardiography
Patients undergo a Transesophageal Echocardiography prior to the ablation itself
Other Names:
  • Any Transesophageal Echocardiography machine
Other: Paperbased neurocognitive testing
To assess the impact of PVI on the patient's neurocognitive status
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
Time Frame: 1-3 days
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
Time Frame: 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
Baseline, 1-3 days and 3 months
Peri-procedural serious adverse events
Time Frame: Within 24 hours after ablation
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
Time Frame: 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)
3 months period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute procedural success rate
Time Frame: During ablation
Acute procedural success of Pulmonary Vein Isolation, defined as electrical isolation of all Pulmonary Veins (entrance block)
During ablation
Success of Pulmonary Vein Isolation
Time Frame: 3 months
Three months ablation success, defined as freedom from symptomatic AF recurrences off antiarrhythmic drug therapy assessed to three-month follow-up
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Collaborators

University Hospital Heidelberg

Investigators

  • Study Chair: Dipen Shah, Prof. Dr., Hôpitaux Universitaires de Genève, Switzerland
  • Study Chair: Boris Schmidt, PD Dr., Cardioangiologisches Centrum Bethanien, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

February 8, 2017

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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