Reduction of AF Ablation Induced Thrombo-Embolic Incidence Pilot Study

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02275260
• Other study ID #: EP025
• Status: Terminated
• Phase: N/A
• Start date: December 2014
• Est. completion date: February 15, 2018

Study information

• Verified date: May 2018
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: February 15, 2018
• Est. primary completion date: February 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Cerebral Diffusion-Weighted Magnetic Resonance Imaging
Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
• Transesophageal Echocardiography
Patients undergo a Transesophageal Echocardiography prior to the ablation itself

Other:
• Paperbased neurocognitive testing
To assess the impact of PVI on the patient's neurocognitive status

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG	University Hospital Heidelberg

Countries where clinical trial is conducted

Czechia,  Germany,  Hungary,  Netherlands,  Switzerland, 

References & Publications (4)

Akca F, Zima E, Végh EM, Széplaki G, Skopál 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. — View Citation

Balázs T, Laczkó R, Bognár E, Akman S, Nagy P, Zima E, Dobránszky J, Szili-Török 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. — View 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. — View Citation

Linhart M, Liberman I, Schrickel JW, Mittmann-Braun EL, Andrié R, Stöckigt 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. — View Citation

Outcome

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