AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
NCT ID: NCT05776797
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
480 participants
INTERVENTIONAL
2023-04-01
2029-03-31
Brief Summary
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Detailed Description
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CRT device will be programmed to a base rate of 70 bpm, hysteresis switched off, and rate response functions activated unless not tolerated by the patient. The triggered mode will be encouraged.
All patients will be regularly followed in outpatient clinics. Cross-over to the AVJA study arm will be considered and performed at any time during the trial at the discretion of the operators. This may particularly concern patients with clinical deterioration in terms of functional status, quality of life, systolic left ventricular function, and/or repeated hospitalization, and in whom biventricular pacing (BiVP%) \<\<100% could be suspected as a significant underlying factor.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT)
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
Ablation of the atrioventricular (AV) node is a procedure used to disrupt or break the electrical connection between the upper heart chambers (the atria) and the lower heart chambers (the ventricles).
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Optimal medication therapy according to the prescription of the physician.
Interventions
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Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
Ablation of the atrioventricular (AV) node is a procedure used to disrupt or break the electrical connection between the upper heart chambers (the atria) and the lower heart chambers (the ventricles).
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Optimal medication therapy according to the prescription of the physician.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of AF and classified as: permanent AF or recurrent persistent AF, requiring emergency visits and/or hospitalizations (at least one in recent year)
* Optimized HF medical treatment and rate control medication
* BiVP% + ventricular premature complex (VPC%) \<99% and \>85% during the minimum period of 1 month while already on optimum medical therapy (applicable only for patients with permanent AF)
* Age \>18 and \<85 years
* Signed informed consent
Exclusion Criteria
* Technical failure of the CRT system
* Intentional preference for spontaneous AV conduction
* Expected survival \<1 year
* Other significant comorbidities and/or conditions that interfere with the proper conduction of the trial
* Dementia as assessed by mini-mental test (\<23 points)
18 Years
85 Years
ALL
No
Sponsors
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University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Jiří Plášek, MD,PhD,FESC
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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Hospital České Budějovice
České Budějovice, Jihočeský kraj, Czechia
Regional Hospital Liberec
Liberec, Liberec Region, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Hospital Podlesí, Inc.
Třinec, Moravian-Silesian Region, Czechia
University Hospital Olomouc
Olomouc, Olomouc Region, Czechia
St. Anne's University Hospital Brno
Brno, South Moravian, Czechia
University Hospital Brno
Brno, South Moravian, Czechia
Institute of Clinical and Experimental Medicine
Prague, , Czechia
Military University Hospital Prague
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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References
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Glikson M, Nielsen JC, Kronborg MB, Michowitz Y, Auricchio A, Barbash IM, Barrabes JA, Boriani G, Braunschweig F, Brignole M, Burri H, Coats AJS, Deharo JC, Delgado V, Diller GP, Israel CW, Keren A, Knops RE, Kotecha D, Leclercq C, Merkely B, Starck C, Thylen I, Tolosana JM; ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021 Sep 14;42(35):3427-3520. doi: 10.1093/eurheartj/ehab364. No abstract available.
Ousdigian KT, Borek PP, Koehler JL, Heywood JT, Ziegler PD, Wilkoff BL. The epidemic of inadequate biventricular pacing in patients with persistent or permanent atrial fibrillation and its association with mortality. Circ Arrhythm Electrophysiol. 2014 Jun;7(3):370-6. doi: 10.1161/CIRCEP.113.001212. Epub 2014 May 17.
Koplan BA, Kaplan AJ, Weiner S, Jones PW, Seth M, Christman SA. Heart failure decompensation and all-cause mortality in relation to percent biventricular pacing in patients with heart failure: is a goal of 100% biventricular pacing necessary? J Am Coll Cardiol. 2009 Jan 27;53(4):355-60. doi: 10.1016/j.jacc.2008.09.043.
Ganesan AN, Brooks AG, Roberts-Thomson KC, Lau DH, Kalman JM, Sanders P. Role of AV nodal ablation in cardiac resynchronization in patients with coexistent atrial fibrillation and heart failure a systematic review. J Am Coll Cardiol. 2012 Feb 21;59(8):719-26. doi: 10.1016/j.jacc.2011.10.891.
Waranugraha Y, Rizal A, Setiawan D, Aziz IJ. The Benefit of Atrioventricular Junction Ablation for Permanent Atrial Fibrillation and Heart Failure Patients Receiving Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis. Indian Pacing Electrophysiol J. 2021 Mar-Apr;21(2):101-111. doi: 10.1016/j.ipej.2020.12.005. Epub 2021 Feb 4.
Dong K, Shen WK, Powell BD, Dong YX, Rea RF, Friedman PA, Hodge DO, Wiste HJ, Webster T, Hayes DL, Cha YM. Atrioventricular nodal ablation predicts survival benefit in patients with atrial fibrillation receiving cardiac resynchronization therapy. Heart Rhythm. 2010 Sep;7(9):1240-5. doi: 10.1016/j.hrthm.2010.02.011. Epub 2010 Feb 13.
Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.
Bozkurt B, Coats AJS, Tsutsui H, Abdelhamid CM, Adamopoulos S, Albert N, Anker SD, Atherton J, Bohm M, Butler J, Drazner MH, Michael Felker G, Filippatos G, Fiuzat M, Fonarow GC, Gomez-Mesa JE, Heidenreich P, Imamura T, Jankowska EA, Januzzi J, Khazanie P, Kinugawa K, Lam CSP, Matsue Y, Metra M, Ohtani T, Francesco Piepoli M, Ponikowski P, Rosano GMC, Sakata Y, Seferovic P, Starling RC, Teerlink JR, Vardeny O, Yamamoto K, Yancy C, Zhang J, Zieroth S. Universal definition and classification of heart failure: a report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure: Endorsed by the Canadian Heart Failure Society, Heart Failure Association of India, Cardiac Society of Australia and New Zealand, and Chinese Heart Failure Association. Eur J Heart Fail. 2021 Mar;23(3):352-380. doi: 10.1002/ejhf.2115. Epub 2021 Mar 3.
Packer M. Development and Evolution of a Hierarchical Clinical Composite End Point for the Evaluation of Drugs and Devices for Acute and Chronic Heart Failure: A 20-Year Perspective. Circulation. 2016 Nov 22;134(21):1664-1678. doi: 10.1161/CIRCULATIONAHA.116.023538.
Hussain A, Misra A, Bozkurt B. Endpoints in Heart Failure Drug Development. Card Fail Rev. 2022 Jan 18;8:e01. doi: 10.15420/cfr.2021.13. eCollection 2022 Jan.
Huber A, Oldridge N, Hofer S. International SF-36 reference values in patients with ischemic heart disease. Qual Life Res. 2016 Nov;25(11):2787-2798. doi: 10.1007/s11136-016-1316-4. Epub 2016 Jun 18.
Other Identifiers
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AMPER-AF trial
Identifier Type: -
Identifier Source: org_study_id
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