Clinical trial NCT02275260: 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
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Heidelberg
First posted: 2014-10-27
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Thromboembolic lesions
timeFrame: 1-3 days
Secondary outcomes:
measure: Neurocognitive status
timeFrame: Baseline, 1-3 days and 3 months
measure: Peri-procedural serious adverse events
timeFrame: Within 24 hours after ablation
measure: Post-procedural clinical TE events
timeFrame: 3 months period
Other outcomes:
measure: Acute procedural success rate
timeFrame: During ablation
measure: Success of Pulmonary Vein Isolation
timeFrame: 3 months
Locations:
city: Budweis
country: Czechia
facility: Ceske Budejovice Hospital
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine (IKEM)
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Campus Virchow
city: Frankfurt/Main
country: Germany
facility: Cardioangologisches Centrum Bethanien (CCB)
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Munich
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
city: Munich
country: Germany
facility: Peter Osypka Herzzentrum München
city: Budapest
country: Hungary
facility: Semmelweis Medical University
city: Amsterdam
country: Netherlands
facility: OLVG - Onze Lieve Vrouwe Gasthuis
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
affiliation: Hôpitaux Universitaires de Genève, Switzerland
name: Dipen Shah, Prof. Dr.
role: STUDY_CHAIR
affiliation: Cardioangiologisches Centrum Bethanien, Germany
name: Boris Schmidt, PD Dr.
role: STUDY_CHAIR
References:
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.
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.
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.
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.