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

June 7, 2023 updated by: University Hospital Ostrava
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 14021
        • Recruiting
        • Institute of clinical and experimental medicine
        • Contact:
        • Principal Investigator:
          • Josef Kautzner, prof.,MD,CSc,FESC
      • Prague, Czechia, 169 02
        • Recruiting
        • Military University Hospital Prague
        • Contact:
        • Principal Investigator:
          • Patrik Jarkovský, MD
    • Liberec Region
      • Liberec, Liberec Region, Czechia, 460 01
        • Recruiting
        • Regional Hospital Liberec
        • Contact:
        • Principal Investigator:
          • Tomáš Roubíček, MD,PhD,FESC
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Jiří Plášek, MD,PhD,FESC
      • Třinec, Moravian-Silesian Region, Czechia, 739 61
        • Recruiting
        • Hospital Podlesí, Inc.
        • Contact:
        • Principal Investigator:
          • Radek Neuwirth, MD,MBA
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Recruiting
        • University Hospital Olomouc
        • Contact:
          • Tomáš Skála, Assoc.Prof.,MD,PhD,FESC
          • Phone Number: 3212 0042058844
          • Email: tomas.skala@fnol.cz
        • Principal Investigator:
          • Tomáš Skála, Assoc.Prof.,MD,PhD,FESC
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Czechia, 370 01
        • Recruiting
        • Hospital Ceské Budejovice
        • Contact:
        • Principal Investigator:
          • Alan Bulava, prof.,MD,Mgr.,PhD
    • South Moravian Region
      • Brno, South Moravian Region, Czechia, 602 00
        • Recruiting
        • St. Anne's University Hospital Brno
        • Contact:
        • Principal Investigator:
          • František Lehár, MD,PhD
      • Brno, South Moravian Region, Czechia, 625 00
        • Recruiting
        • University Hospital Brno
        • Contact:
        • Principal Investigator:
          • Lubomír Křivan, Assoc.Prof.,MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT)
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.
Procedure: Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
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).
Active Comparator: Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.
Drug: Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Optimal medication therapy according to the prescription of the physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure (HF) events
Time Frame: 3 years
The number of HF events will be observed.
3 years
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 years
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.
3 years
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.
3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 3 years
Patient deaths from all causes will be observed, recorded and analysed.
3 years
Death from cardiovascular diseases (CV death)
Time Frame: 3 years
Incidents of CV death will be observed, recorded and analysed.
3 years
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.
3 years
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.
3 years
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.
3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Jiří Plášek, MD,PhD,FESC, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMPER-AF trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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