2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.
Michael Glikson, Jens Cosedis Nielsen, Mads Brix Kronborg...
https://pubmed.ncbi.nlm.nih.gov/34455430Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID05776797
AV Junction Ablation or Optimal Medical Treatment in Patients With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Led by University Hospital Ostrava · Updated on 2023-06-08
480
Participants Needed
9
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare atrioventricular junction ablation (AVJA) with continued optimal medication treatment for patients who have cardiac resynchronization therapy (CRT) and permanent or recurrent persistent atrial fibrillation (AF) with suboptimal heart rate control despite optimal medication. The study will randomly assign participants to one of two groups to evaluate which approach better manages heart function and quality of life over time. Participants will be randomly divided into two groups in equal numbers. One group will undergo AVJA, a procedure that disrupts the electrical connection between the upper and lower chambers of the heart, performed soon after randomization and repeated if necessary. The other group will continue with optimal medication treatment prescribed by their physician. CRT devices will be programmed uniformly with a base rate of 70 bpm and rate response functions activated unless not tolerated. Throughout the study, all participants will be regularly monitored at outpatient clinics. Researchers will assess heart failure events, quality of life using standardized questionnaires, medication doses, and heart function classification over a 3-year period. Secondary outcomes include mortality rates, heart failure hospitalizations, blood biomarker changes, and hospitalization days. Participants may switch from medication to AVJA if clinical deterioration occurs. The total study duration extends to 3 years with comprehensive follow-up to track these outcomes.
CONDITIONS
Brief Title
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Treatment with cardiac resynchronization therapy (CRT) using a biventricular pacemaker, defibrillator, or conduction system pacemaker for more than 6 months
- Diagnosis of permanent atrial fibrillation (AF) or recurrent persistent AF requiring emergency visits or hospitalizations at least once in the past year
- Optimized heart failure (HF) medical treatment and rate control medication
- For permanent AF patients, biventricular pacing plus ventricular premature complex percentage between 85% and less than 99% during at least 1 month on optimal medication
- Age between 18 and 85 years
- Signed informed consent
You will not qualify if you...
- Myocardial infarction or coronary artery bypass graft surgery within the last 3 months
- Technical failure of the CRT system
- Intentional preference for spontaneous atrioventricular conduction
- Expected survival less than 1 year
- Other significant comorbidities or conditions interfering with the trial
- Dementia with mini-mental test score below 23 points
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 years
Participants are randomly assigned to receive either atrioventricular junction ablation or optimal medication treatment for their cardiac condition.
Regular outpatient visits during treatment
Follow-up
Duration - Up to 3 years
Participants are regularly followed in outpatient clinics for monitoring of heart failure events, quality of life, and other health outcomes after treatment.
Regular outpatient visits during follow-up
Trial Site Locations
Total: 9 locations
1
Regional Hospital Liberec
Liberec, Liberec Region, Czechia, 460 01
Actively Recruiting
2
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852
Actively Recruiting
3
Hospital Podlesí, Inc.
Třinec, Moravian-Silesian Region, Czechia, 739 61
Actively Recruiting
4
University Hospital Olomouc
Olomouc, Olomouc Region, Czechia, 779 00
Actively Recruiting
5
Hospital České Budějovice
České Budějovice, South Bohemian Region, Czechia, 370 01
Actively Recruiting
6
St. Anne's University Hospital Brno
Brno, South Moravian, Czechia, 602 00
Actively Recruiting
7
University Hospital Brno
Brno, South Moravian, Czechia, 625 00
Actively Recruiting
8
Institute of Clinical and Experimental Medicine
Prague, Czechia, 14021
Actively Recruiting
9
Military University Hospital Prague
Prague, Czechia, 169 02
Actively Recruiting
Loading map...
Research Team
J
Jiří Hynčica
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The epidemic of inadequate biventricular pacing in patients with persistent or permanent atrial fibrillation and its association with mortality.
Kevin T Ousdigian, P Peter Borek, Jodi L Koehler...
https://pubmed.ncbi.nlm.nih.gov/24838004Heart failure decompensation and all-cause mortality in relation to percent biventricular pacing in patients with heart failure: is a goal of 100% biventricular pacing necessary?
Bruce A Koplan, Andrew J Kaplan, Stan Weiner...
https://pubmed.ncbi.nlm.nih.gov/19161886Role of AV nodal ablation in cardiac resynchronization in patients with coexistent atrial fibrillation and heart failure a systematic review.
Anand N Ganesan, Anthony G Brooks, Kurt C Roberts-Thomson...
https://pubmed.ncbi.nlm.nih.gov/22340263The Benefit of Atrioventricular Junction Ablation for Permanent Atrial Fibrillation and Heart Failure Patients Receiving Cardiac Resynchronization Therapy: An Updated Systematic Review and Meta-analysis.
Yoga Waranugraha, Ardian Rizal, Dion Setiawan...
https://pubmed.ncbi.nlm.nih.gov/33548449Atrioventricular nodal ablation predicts survival benefit in patients with atrial fibrillation receiving cardiac resynchronization therapy.
Kan Dong, Win-Kuang Shen, Brian D Powell...
https://pubmed.ncbi.nlm.nih.gov/20156595The Seattle Heart Failure Model: prediction of survival in heart failure.
Wayne C Levy, Dariush Mozaffarian, David T Linker...
https://pubmed.ncbi.nlm.nih.gov/16534009Universal definition and classification of heart failure: a report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure: Endorsed by the Canadian Heart Failure Society, Heart Failure Association of India, Cardiac Society of Australia and New Zealand, and Chinese Heart Failure Association.
Biykem Bozkurt, Andrew J S Coats, Hiroyuki Tsutsui...
https://pubmed.ncbi.nlm.nih.gov/33605000Development and Evolution of a Hierarchical Clinical Composite End Point for the Evaluation of Drugs and Devices for Acute and Chronic Heart Failure: A 20-Year Perspective.
Milton Packer
https://pubmed.ncbi.nlm.nih.gov/27881506Endpoints in Heart Failure Drug Development.
Aliza Hussain, Arunima Misra, Biykem Bozkurt
https://pubmed.ncbi.nlm.nih.gov/35111335