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Recurrent Atrial FibrillationAMPER-AFNCT05776797

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

A study testing Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT) and Optimal medication treatment in patients with cardiac resynchronization therapy (CRT) in people with Recurrent Atrial Fibrillation and Persistent Atrial Fibrillation, run by University Hospital Ostrava at 9 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT) and Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
9 sitesCzechia
Study dates
1 Apr 2023to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jiří Hynčica contact

0042059737 ext. 2587

jiri.hyncica@fno.cz

9 sites in 1 country

Czechia9 sites, 9 recruiting

  • St. Anne's University Hospital Brno

    Brno, South Moravian, 602 00

    František Lehár, MD,PhD, 0042054318 ext. 2187, frantisek.lehar@fnusa.cz

    František Lehár, MD,PhD

    Recruiting

  • University Hospital Brno

    Brno, South Moravian, 625 00

    Lubomír Křivan, Assoc.Prof.,MD,PhD, 0042053223 ext. 2451, lubomir.krivan@med.muni.cz

    Lubomír Křivan, Assoc.Prof.,MD,PhD

    Recruiting

  • Hospital České Budějovice

    České Budějovice, South Bohemian Region, 370 01

    Alan Bulava, prof.,MD,Mgr.,PhD, 0042038787 ext. 2006, bulava.alan@nemcb.cz

    Alan Bulava, prof.,MD,Mgr.,PhD

    Recruiting

  • Regional Hospital Liberec

    Liberec, Liberec Region, 460 01

    Tomáš Roubíček, MD,PhD,FESC, 0042048531 ext. 2847, tomas.roubicek@nemlib.cz

    Tomáš Roubíček, MD,PhD,FESC

    Recruiting

  • University Hospital Olomouc

    Olomouc, Olomouc Region, 779 00

    Tomáš Skála, Assoc.Prof.,MD,PhD,FESC, 0042058844 ext. 3212, tomas.skala@fnol.cz

    Tomáš Skála, Assoc.Prof.,MD,PhD,FESC

    Recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region, 70852

    Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz

    Jiří Plášek, MD,PhD,FESC

    Recruiting

  • Institute of Clinical and Experimental Medicine

    Prague, 14021

    Josef Kautzner, prof.,MD,CSc,FESC, 0042023605 ext. 5006, josef.kautzner@ikem.cz

    Josef Kautzner, prof.,MD,CSc,FESC

    Recruiting

  • Military University Hospital Prague

    Prague, 169 02

    Patrik Jarkovský, MD, 97320 ext. 3047, patrik.jarkovsky@uvn.cz

    Patrik Jarkovský, MD

    Recruiting

  • Hospital Podlesí, Inc.

    Třinec, Moravian-Silesian Region, 739 61

    Radek Neuwirth, MD,MBA, 0042055830 ext. 4140, radek.neuwirth@npo.agel.cz

    Radek Neuwirth, MD,MBA

    Recruiting

Other trials in Czechia

About this study

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.

Read the detailed description

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.

Being tested
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT), Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Keywords
atrial fibrillation, atrioventricular junction ablation, biventricular pacing, heart rate control, cardiac resynchronization therapy
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)Procedure or surgery

    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)Drug

    Optimal medication therapy according to the prescription of the physician.

Study groups in NCT05776797
Study groupRoleWhat they receive
Atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT)ExperimentalPatients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.
Receives: Procedure: Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)Active comparatorPatients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.
Receives: Drug: Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart failure (HF) events

    The number of HF events will be observed.

    Measured: 3 years

  2. 36-Item Quality of Life (QoL)

    QoL will be assessed using the 36-Item Quality of Life Questionnaire. QoL will be evaluated at 12, 24 and 36 months as a sum of points that are assigned to individual outcome measures, specifically to their change compared to the baseline.

    To score the SF-36, scales are standardized to obtain a score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales.

    Measured: 3 years

  3. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    MLHFQ values will be recorded and evaluated at 12, 24 and 36 months. The questionnaire is comprised of 21 questions around several physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. The patient marks a 0 (zero) to 5 (five) scale to indicate the extent to which each itemized adversity of heart failure has prevented the patient from living as they wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.

    Measured: 3 years

  4. Dose of loop diuretics

    Change in the dose of loop diuretics will be observed and recorded. This parameter will be evaluated at 12, 24 and 36 months as an increase or decrease of the dose compared to the baseline.

    Measured: 3 years

  5. NYHA classification

    Changes in the New York Heart Association classification (NYHA) will be observed. The NYHA classification values will be evaluated at 12, 24 and 36 months. The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain.

    Measured: 3 years

Secondary outcomes (6)

  1. All-cause death

    Patient deaths from all causes will be observed, recorded and analysed.

    Measured: 3 years

  2. Death from cardiovascular diseases (CV death)

    Incidents of CV death will be observed, recorded and analysed.

    Measured: 3 years

  3. Combined heart failure (HF) death and HF hospitalization

    Incidents of combined heart failure (HF) death and HF hospitalization will be observed, recorded and analysed.

    Measured: 3 years

  4. Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP)

    The time-averaged proportional change in NT-pro-BNP will be observed, recorded and analysed.

    Measured: 3 years

  5. Days in the hospital because of heart failure (HF)

    The number of days in the hospital because of heart failure (HF) will be recorded.

    Measured: 3 years

  6. Time-averaged change in the NYHA class

    The time-averaged change in the NYHA class will be observed, recorded and analysed.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start1 Apr 2023
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776797
Sponsor's protocol ID
AMPER-AF trial
Acronym
AMPER-AF
Status last verified
Jun 2023
First submitted
10 Feb 2023
Last updated
8 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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 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.

    PubMed 33605000

  • 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.

    PubMed 27881506

  • 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.

    PubMed 35111335

  • 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.

    PubMed 27318487

Questions about this trial

What is this clinical trial studying?

A study testing Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT) and Optimal medication treatment in patients with cardiac resynchronization therapy (CRT) in people with Recurrent Atrial Fibrillation and Persistent Atrial Fibrillation, run by University Hospital Ostrava at 9 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart failure (HF) events (time frame: 3 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05776797, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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