NCT05776797Recruiting
AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 8 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 480 (estimated)
- First submitted
- 10 Feb 2023
- Start date
- 1 Apr 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University Hospital Ostrava
- Diseases
- Atrial fibrillation
- NCT number
- NCT05776797
What you commit to
- Study type: Interventional
- Planned participants: 480
- From 1 Apr 2023 to the primary completion date, 31 Dec 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- myocardial infarction (MI) or coronary artery bypass graft (CABG) \<3 months
- Technical failure of the CRT system
- Other significant comorbidities and/or conditions that interfere with the proper conduction of the trial
- Dementia as assessed by mini-mental test (\<23 points)
Other
- Intentional preference for spontaneous AV conduction
- Expected survival \<1 year
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Anne's University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Hospital České Budějovice Coordinator of this site? Confirm its status | České Budějovice | Czechia | Recruiting |
| Regional Hospital Liberec Coordinator of this site? Confirm its status | Liberec | Czechia | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| University Hospital Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Institute of Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Military University Hospital Prague Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Hospital Podlesí, Inc. Coordinator of this site? Confirm its status | Třinec | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.