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NCT Number: NCT05776797

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

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.

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Key information

Conditions

Recurrent Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Atrial Fibrillation

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital Liberec, Liberec, Liberec Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. Heart failure (HF) events

    Time frame: 3 years

    The number of HF events will be observed.

  2. 36-Item Quality of Life (QoL)

    Time frame: 3 years

    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.

  3. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: 3 years

    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.

  4. Dose of loop diuretics

    Time frame: 3 years

    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.

  5. NYHA classification

    Time frame: 3 years

    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.

Secondary outcomes

  1. All-cause death

    Time frame: 3 years

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

  2. Death from cardiovascular diseases (CV death)

    Time frame: 3 years

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

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

    Time frame: 3 years

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

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

    Time frame: 3 years

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

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

    Time frame: 3 years

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

  6. Time-averaged change in the NYHA class

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Acronym: AMPER-AF

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Mar 20, 2023
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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