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Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cerebral Diffusion-Weighted Magnetic Resonance Imaging
Transesophageal Echocardiography
Paperbased neurocognitive testing
Sponsored by
Biotronik SE & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ceske Budejovice Hospital
  • Institute for Clinical and Experimental Medicine (IKEM)
  • Kerckhoff-Klinik
  • Herz- und Diabeteszentrum NRW
  • Charité Campus Benjamin Franklin
  • Charité Campus Virchow
  • Cardioangologisches Centrum Bethanien (CCB)
  • Universität Leipzig
  • Deutsches Herzzentrum München des Freistaates Bayern
  • Peter Osypka Herzzentrum München
  • Semmelweis Medical University
  • OLVG - Onze Lieve Vrouwe Gasthuis
  • Haga Ziekenhuis
  • Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

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

Outcomes

Primary Outcome Measures

Thromboembolic lesions
The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI

Secondary Outcome Measures

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
Peri-procedural serious adverse events
Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure
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)

Full Information

First Posted
October 21, 2014
Last Updated
October 30, 2019
Sponsor
Biotronik SE & Co. KG
Collaborators
University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT02275260
Brief Title
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study
Official Title
Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study (REDUCE-TE Pilot)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
The required number of endpoints will be obtained with a sample size lower than initially planned.
Study Start Date
December 2014 (Actual)
Primary Completion Date
February 8, 2017 (Actual)
Study Completion Date
February 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik SE & Co. KG
Collaborators
University Hospital Heidelberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
All patients undergo cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Transesophageal (or Intracardial) Echocardiography and paperbased neurocognitive testing
Intervention Type
Device
Intervention Name(s)
Cerebral Diffusion-Weighted Magnetic Resonance Imaging
Other Intervention Name(s)
1.5-3 T machine capable of Diffusion-Weighted MRI
Intervention Description
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
Intervention Type
Device
Intervention Name(s)
Transesophageal Echocardiography
Other Intervention Name(s)
Any Transesophageal Echocardiography machine
Intervention Description
Patients undergo a Transesophageal Echocardiography prior to the ablation itself
Intervention Type
Other
Intervention Name(s)
Paperbased neurocognitive testing
Other Intervention Name(s)
STATE questionnaire, d2 test, visual VVM2, MOCA subtest
Intervention Description
To assess the impact of PVI on the patient's neurocognitive status
Primary Outcome Measure Information:
Title
Thromboembolic lesions
Description
The occurrence of one or more new subclinical cerebral thromboembolic lesions after Pulmonary Vein Isolation assessed by Diffusion-Weighted MRI
Time Frame
1-3 days
Secondary Outcome Measure Information:
Title
Neurocognitive status
Description
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
Time Frame
Baseline, 1-3 days and 3 months
Title
Peri-procedural serious adverse events
Description
Any serious adverse event occurring during the ablation procedure and within 24 hours from completion of the procedure
Time Frame
Within 24 hours after ablation
Title
Post-procedural clinical TE events
Description
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)
Time Frame
3 months period
Other Pre-specified Outcome Measures:
Title
Acute procedural success rate
Description
Acute procedural success of Pulmonary Vein Isolation, defined as electrical isolation of all Pulmonary Veins (entrance block)
Time Frame
During ablation
Title
Success of Pulmonary Vein Isolation
Description
Three months ablation success, defined as freedom from symptomatic AF recurrences off antiarrhythmic drug therapy assessed to three-month follow-up
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dipen Shah, Prof. Dr.
Organizational Affiliation
Hôpitaux Universitaires de Genève, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Boris Schmidt, PD Dr.
Organizational Affiliation
Cardioangiologisches Centrum Bethanien, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Ceske Budejovice Hospital
City
Budweis
Country
Czechia
Facility Name
Institute for Clinical and Experimental Medicine (IKEM)
City
Prague
Country
Czechia
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW
City
Bad Oeynhausen
Country
Germany
Facility Name
Charité Campus Benjamin Franklin
City
Berlin
Country
Germany
Facility Name
Charité Campus Virchow
City
Berlin
Country
Germany
Facility Name
Cardioangologisches Centrum Bethanien (CCB)
City
Frankfurt/Main
Country
Germany
Facility Name
Universität Leipzig
City
Leipzig
Country
Germany
Facility Name
Deutsches Herzzentrum München des Freistaates Bayern
City
Munich
Country
Germany
Facility Name
Peter Osypka Herzzentrum München
City
Munich
Country
Germany
Facility Name
Semmelweis Medical University
City
Budapest
Country
Hungary
Facility Name
OLVG - Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23875670
Citation
Akca F, Zima E, Vegh EM, Szeplaki G, Skopal J, Hubay M, Lendvai Z, Merkely B, Szili-Torok T. Radiofrequency ablation at low irrigation flow rates using a novel 12-hole gold open-irrigation catheter. Pacing Clin Electrophysiol. 2013 Nov;36(11):1373-81. doi: 10.1111/pace.12215. Epub 2013 Jul 22.
Results Reference
background
PubMed Identifier
23100094
Citation
Balazs T, Laczko R, Bognar E, Akman S, Nagy P, Zima E, Dobranszky J, Szili-Torok T. Ablation time efficiency and lesion volume - in vitro comparison of 4 mm, non irrigated, gold- and platinum-iridium-tip radiofrequency ablation catheters. J Interv Card Electrophysiol. 2013 Jan;36(1):13-8; discussion 18. doi: 10.1007/s10840-012-9743-9. Epub 2012 Oct 26.
Results Reference
background
PubMed Identifier
22429859
Citation
Linhart M, Liberman I, Schrickel JW, Mittmann-Braun EL, Andrie R, Stockigt F, Kreuz J, Nickenig G, Lickfett LM. Superiority of gold versus platinum irrigated tip catheter ablation of the pulmonary veins and the cavotricuspid isthmus: a randomized study comparing tip temperatures and cooling flow requirements. J Cardiovasc Electrophysiol. 2012 Jul;23(7):717-21. doi: 10.1111/j.1540-8167.2011.02267.x. Epub 2012 Mar 19.
Results Reference
background
PubMed Identifier
20876601
Citation
Lewalter T, Weiss C, Spencker S, Jung W, Haverkamp W, Willems S, Deneke T, Kautzner J, Wiedemann M, Siebels J, Pitschner HF, Hoffmann E, Hindricks G, Zabel M, Vester E, Schwacke H, Mittmann-Braun E, Lickfett L, Hoffmeister S, Proff J, Mewis C, Bauer W; AURUM 8 Study Investigators. Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study. Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28.
Results Reference
background

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Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

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