Clinical trial NCT05776797: AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Official title: AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Atrial Fibrillation
Persistent Atrial Fibrillation
Keywords: atrial fibrillation
atrioventricular junction ablation
biventricular pacing
heart rate control
cardiac resynchronization therapy
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Heart failure (HF) events
timeFrame: 3 years
measure: 36-Item Quality of Life (QoL)
timeFrame: 3 years
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 3 years
measure: Dose of loop diuretics
timeFrame: 3 years
measure: NYHA classification
timeFrame: 3 years
Secondary outcomes:
measure: All-cause death
timeFrame: 3 years
measure: Death from cardiovascular diseases (CV death)
timeFrame: 3 years
measure: Combined heart failure (HF) death and HF hospitalization
timeFrame: 3 years
measure: Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP)
timeFrame: 3 years
measure: Days in the hospital because of heart failure (HF)
timeFrame: 3 years
measure: Time-averaged change in the NYHA class
timeFrame: 3 years
Other outcomes:
Locations:
city: Liberec
country: Czechia
facility: Regional Hospital Liberec
state: Liberec Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Třinec
country: Czechia
facility: Hospital Podlesí, Inc.
state: Moravian-Silesian Region
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
state: Olomouc Region
city: České Budějovice
country: Czechia
facility: Hospital České Budějovice
state: South Bohemian Region
city: Brno
country: Czechia
facility: St. Anne's University Hospital Brno
state: South Moravian Region
city: Brno
country: Czechia
facility: University Hospital Brno
state: South Moravian Region
city: Prague
country: Czechia
facility: Institute of Clinical and Experimental Medicine
city: Prague
country: Czechia
facility: Military University Hospital Prague
Study officials:
affiliation: University Hospital Ostrava
name: Jiří Plášek, MD,PhD,FESC
role: PRINCIPAL_INVESTIGATOR
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