Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

NCT02275260 | Terminated

• 1 other identifier: EP025
• Study Type: interventional
• Target: 110
• Locations: 5 countries
• Sites: 14

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Neurocognitive status

  Baseline, 1-3 days and 3 months

• Peri-procedural serious adverse events

  Within 24 hours after ablation

• Post-procedural clinical TE events

  3 months period

Other Outcomes (2)

• Acute procedural success rate

  During ablation

• Success of Pulmonary Vein Isolation

  3 months

Study Arms (1)

All patients

EXPERIMENTAL

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; Device: Transesophageal Echocardiography; Other: Paperbased neurocognitive testing

Interventions

Cerebral Diffusion-Weighted Magnetic Resonance Imaging DEVICE

Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)

Also known as: 1.5-3 T machine capable of Diffusion-Weighted MRI

All patients

Transesophageal Echocardiography DEVICE

Patients undergo a Transesophageal Echocardiography prior to the ablation itself

Also known as: Any Transesophageal Echocardiography machine

All patients

Paperbased neurocognitive testing OTHER

To assess the impact of PVI on the patient's neurocognitive status

Also known as: STATE questionnaire, d2 test, visual VVM2, MOCA subtest

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead
• University Hospital Heidelberg: collaborator

Study Sites (14)

Ceske Budejovice Hospital

České Budějovice, Czechia

Location

Institute for Clinical and Experimental Medicine (IKEM)

Prague, Czechia

Location

Kerckhoff-Klinik

Bad Nauheim, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Charité Campus Benjamin Franklin

Berlin, Germany

Location

Charité Campus Virchow

Berlin, Germany

Location

Cardioangologisches Centrum Bethanien (CCB)

Frankfurt am Main, Germany

Location

Universität Leipzig

Leipzig, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

Munich, Germany

Location

Peter Osypka Herzzentrum München

Munich, Germany

Location

Semmelweis Medical University

Budapest, Hungary

Location

OLVG - Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

Hôpitaux Universitaires de Genève

Geneva, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 23875670 BACKGROUND

• 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.

  PMID: 23100094 BACKGROUND

• 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.

  PMID: 22429859 BACKGROUND

• 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.

  PMID: 20876601 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Dipen Shah, Prof. Dr.

  Hôpitaux Universitaires de Genève, Switzerland

  STUDY CHAIR

• Boris Schmidt, PD Dr.

  Cardioangiologisches Centrum Bethanien, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 27, 2014
• Study Start: December 1, 2014
• Primary Completion: February 8, 2017
• Study Completion: February 15, 2018
• Last Updated: November 1, 2019

Record last verified: 2018-05

Locations

HU (1); CH (1); NL (2); CZ (2); DE (8)