AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation (AMPER-AF)

University Hospital Ostrava

Status: Enrolling

Conditions: Persistent Atrial Fibrillation; Recurrent Atrial Fibrillation

Treatments: Drug: Optimal medication treatment in patients with cardiac resynchronization therapy (CRT); Procedure: Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05776797

AMPER-AF trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

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

Experimental group

Description:

Patients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.

Treatment:

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

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

Active Comparator group

Description:

Patients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.

Treatment:

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