Back to resultsAV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation (AMPER-AF)
Primary Purpose
Recurrent Atrial Fibrillation, Persistent Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Atrial Fibrillation focused on measuring atrial fibrillation, atrioventricular junction ablation, biventricular pacing, heart rate control, cardiac resynchronization therapy
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)
Sites / Locations
- Regional Hospital LiberecRecruiting
- University Hospital OstravaRecruiting
- Hospital Podlesí, Inc.Recruiting
- University Hospital OlomoucRecruiting
- Hospital České BudějoviceRecruiting
- St. Anne's University Hospital BrnoRecruiting
- University Hospital BrnoRecruiting
- Institute of Clinical and Experimental MedicineRecruiting
- Military University Hospital PragueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT)
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Arm Description
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.
Outcomes
Primary Outcome Measures
Heart failure (HF) events
The number of HF events will be observed.
36-Item Quality of Life (QoL)
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.
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
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.
Dose of loop diuretics
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.
NYHA classification
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 Outcome Measures
All-cause death
Patient deaths from all causes will be observed, recorded and analysed.
Death from cardiovascular diseases (CV death)
Incidents of CV death will be observed, recorded and analysed.
Combined heart failure (HF) death and HF hospitalization
Incidents of combined heart failure (HF) death and HF hospitalization will be observed, recorded and analysed.
Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP)
The time-averaged proportional change in NT-pro-BNP will be observed, recorded and analysed.
Days in the hospital because of heart failure (HF)
The number of days in the hospital because of heart failure (HF) will be recorded.
Time-averaged change in the NYHA class
The time-averaged change in the NYHA class will be observed, recorded and analysed.
Full Information
NCT ID
NCT05776797
First Posted
February 10, 2023
Last Updated
June 7, 2023
Sponsor
University Hospital Ostrava
1. Study Identification
Unique Protocol Identification Number
NCT05776797
Brief Title
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Acronym
AMPER-AF
Official Title
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords
atrial fibrillation, atrioventricular junction ablation, biventricular pacing, heart rate control, cardiac resynchronization therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
No masking will be used in the study
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Atrioventricular junction ablation (AVJA) in patients with cardiac resynchronization therapy (CRT)
Arm Type
Experimental
Arm Description
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will undergo atrioventricular junction ablation.
Arm Title
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Arm Type
Active Comparator
Arm Description
Patients with cardiac resynchronization therapy (CRT) randomized in this arm will receive optimal medication treatment.
Intervention Type
Procedure
Intervention Name(s)
Atrioventricular junction ablation in patients with cardiac resynchronization therapy (CRT)
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)
Intervention Description
Optimal medication therapy according to the prescription of the physician.
Primary Outcome Measure Information:
Title
Heart failure (HF) events
Description
The number of HF events will be observed.
Time Frame
3 years
Title
36-Item Quality of Life (QoL)
Description
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.
Time Frame
3 years
Title
Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Description
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.
Time Frame
3 years
Title
Dose of loop diuretics
Description
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.
Time Frame
3 years
Title
NYHA classification
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
All-cause death
Description
Patient deaths from all causes will be observed, recorded and analysed.
Time Frame
3 years
Title
Death from cardiovascular diseases (CV death)
Description
Incidents of CV death will be observed, recorded and analysed.
Time Frame
3 years
Title
Combined heart failure (HF) death and HF hospitalization
Description
Incidents of combined heart failure (HF) death and HF hospitalization will be observed, recorded and analysed.
Time Frame
3 years
Title
Time-averaged proportional change in NT-pro-Brain Natriuretic Peptide (NT-pro-BNP)
Description
The time-averaged proportional change in NT-pro-BNP will be observed, recorded and analysed.
Time Frame
3 years
Title
Days in the hospital because of heart failure (HF)
Description
The number of days in the hospital because of heart failure (HF) will be recorded.
Time Frame
3 years
Title
Time-averaged change in the NYHA class
Description
The time-averaged change in the NYHA class will be observed, recorded and analysed.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiří Plášek, MD,PhD,FESC
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital Liberec
City
Liberec
State/Province
Liberec Region
ZIP/Postal Code
460 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomáš Roubíček, MD,PhD,FESC
Phone
0042048531
Ext
2847
Email
tomas.roubicek@nemlib.cz
First Name & Middle Initial & Last Name & Degree
Tomáš Roubíček, MD,PhD,FESC
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Jiří Plášek, MD,PhD,FESC
Facility Name
Hospital Podlesí, Inc.
City
Třinec
State/Province
Moravian-Silesian Region
ZIP/Postal Code
739 61
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radek Neuwirth, MD,MBA
Phone
0042055830
Ext
4140
Email
radek.neuwirth@npo.agel.cz
First Name & Middle Initial & Last Name & Degree
Radek Neuwirth, MD,MBA
Facility Name
University Hospital Olomouc
City
Olomouc
State/Province
Olomouc Region
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomáš Skála, Assoc.Prof.,MD,PhD,FESC
Phone
0042058844
Ext
3212
Email
tomas.skala@fnol.cz
First Name & Middle Initial & Last Name & Degree
Tomáš Skála, Assoc.Prof.,MD,PhD,FESC
Facility Name
Hospital České Budějovice
City
České Budějovice
State/Province
South Bohemian Region
ZIP/Postal Code
370 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Bulava, prof.,MD,Mgr.,PhD
Phone
0042038787
Ext
2006
Email
bulava.alan@nemcb.cz
First Name & Middle Initial & Last Name & Degree
Alan Bulava, prof.,MD,Mgr.,PhD
Facility Name
St. Anne's University Hospital Brno
City
Brno
State/Province
South Moravian Region
ZIP/Postal Code
602 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
František Lehár, MD,PhD
Phone
0042054318
Ext
2187
Email
frantisek.lehar@fnusa.cz
First Name & Middle Initial & Last Name & Degree
František Lehár, MD,PhD
Facility Name
University Hospital Brno
City
Brno
State/Province
South Moravian Region
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lubomír Křivan, Assoc.Prof.,MD,PhD
Phone
0042053223
Ext
2451
Email
lubomir.krivan@med.muni.cz
First Name & Middle Initial & Last Name & Degree
Lubomír Křivan, Assoc.Prof.,MD,PhD
Facility Name
Institute of Clinical and Experimental Medicine
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josef Kautzner, prof.,MD,CSc,FESC
Phone
0042023605
Ext
5006
Email
josef.kautzner@ikem.cz
First Name & Middle Initial & Last Name & Degree
Josef Kautzner, prof.,MD,CSc,FESC
Facility Name
Military University Hospital Prague
City
Prague
ZIP/Postal Code
169 02
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrik Jarkovský, MD
Phone
97320
Ext
3047
Email
patrik.jarkovsky@uvn.cz
First Name & Middle Initial & Last Name & Degree
Patrik Jarkovský, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
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