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

Last updated: June 7, 2023
Sponsor: University Hospital Ostrava
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atrial Fibrillation

Arrhythmia

Dysrhythmia

Treatment

Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)

Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)

Clinical Study ID

NCT05776797
AMPER-AF trial
  • Ages 18-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Treatment with CRT using either a biventricular pacemaker/defibrillator or conductionsystem pacemaker (>6 months)
  • Diagnosis of AF and classified as: permanent AF or recurrent persistent AF, requiringemergency 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 periodof 1 month while already on optimum medical therapy (applicable only for patients withpermanent AF)
  • Age >18 and <85 years
  • Signed informed consent

Exclusion

Exclusion Criteria:

  • 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 properconduction of the trial
  • Dementia as assessed by mini-mental test (<23 points)

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Phase:
Study Start date:
April 01, 2023
Estimated Completion Date:
March 31, 2029

Study 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.

Connect with a study center

  • Regional Hospital Liberec

    Liberec, Liberec Region 460 01
    Czechia

    Active - Recruiting

  • University Hospital Ostrava

    Ostrava, Moravian-Silesian Region 70852
    Czechia

    Active - Recruiting

  • Hospital Podlesí, Inc.

    Třinec, Moravian-Silesian Region 739 61
    Czechia

    Active - Recruiting

  • University Hospital Olomouc

    Olomouc, Olomouc Region 779 00
    Czechia

    Active - Recruiting

  • Hospital České Budějovice

    České Budějovice, South Bohemian Region 370 01
    Czechia

    Active - Recruiting

  • St. Anne's University Hospital Brno

    Brno, South Moravian Region 602 00
    Czechia

    Active - Recruiting

  • University Hospital Brno

    Brno, South Moravian Region 625 00
    Czechia

    Active - Recruiting

  • Institute of Clinical and Experimental Medicine

    Prague, 14021
    Czechia

    Active - Recruiting

  • Military University Hospital Prague

    Prague, 169 02
    Czechia

    Active - Recruiting

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