AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation

Обзор

A study comparing atrioventricular junction ablation (AVJA) versus continued optimum medical rate control in patients with cardiac resynchronization therapy (CRT) and atrial fibrillation (AF) with suboptimal heart rate control on optimum medication.

Подробное описание

Patients fulfilling the enrolment criteria will be randomly (randomization with variable blocks of 4, 6, and 8 patients) allocated to intervention and control groups in a 1:1 ratio. AVJA will be done in patients belonging to the intervention group without undue delay after the randomization. The procedure will be repeated in case of recovery of AV nodal conduction during the trial.

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.

Вмешательства

• Процедура 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).
• Препарат Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
  Optimal medication therapy according to the prescription of the physician.

Первичные конечные точки

• Heart failure (HF) events [Срок оценки: 3 years]
• 36-Item Quality of Life (QoL) [Срок оценки: 3 years]
• Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Срок оценки: 3 years]
• Dose of loop diuretics [Срок оценки: 3 years]
• NYHA classification [Срок оценки: 3 years]

Вторичные конечные точки (6)

• All-cause death [Срок оценки: 3 years]
• Death from cardiovascular diseases (CV death) [Срок оценки: 3 years]
• Combined heart failure (HF) death and HF hospitalization [Срок оценки: 3 years]
• Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP) [Срок оценки: 3 years]
• Days in the hospital because of heart failure (HF) [Срок оценки: 3 years]
• Time-averaged change in the NYHA class [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Treatment with CRT using either a biventricular pacemaker/defibrillator or conduction system pacemaker (>6 months)
• 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

Критерии исключения

• myocardial infarction (MI) or coronary artery bypass graft (CABG) <3 months
• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Чехия · 9 центров

• Regional Hospital Liberec — Liberec
• University Hospital Ostrava — Ostrava
• Hospital Podlesí, Inc. — Třinec
• University Hospital Olomouc — Olomouc
• Hospital České Budějovice — České Budějovice
• St. Anne's University Hospital Brno — Brno
• University Hospital Brno — Brno
• Institute of Clinical and Experimental Medicine — Prague
• … и ещё 1 центр

Публикации

• 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. 202 PMID 34455430
• 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. PMID 24838004
• 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. PMID 19161886
• 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. PMID 22340263
• 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. PMID 33548449
• 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. PMID 20156595
• 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. PMID 16534009
• 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 J PMID 33605000

Идентификаторы

NCT: NCT05776797 · AMPER-AF trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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