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New treatment option for Recurrent Atrial Fibrillation
Official title AV Junction Ablation or Optimal Medical Treatment in PatiEnts With Cardiac Resynchronization Therapy and Permanent Atrial Fibrillation
ClinicalTrials.gov ID: NCT05776797
What this study is testing
What is Optimal medication treatment in patients with cardiac resynchronization therapy (CRT)?
Optimal medication treatment in patients with cardiac resynchronization therapy (CRT) is an investigational medicine, being studied as a potential treatment for recurrent atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Optimized HF medical treatment and rate control medication
- BiVP% + ventricular premature complex (VPC%) \ 85% during the minimum period of 1 month while already on optimum medical therapy (applicable only for...
- Age \>18 and \<85 years
You likely can't join if
- 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)
See the full eligibility 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%) \ 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Liberec, Liberec Region, Czechia
- Ostrava, Moravian-Silesian Region, Czechia
- Třinec, Moravian-Silesian Region, Czechia
- Olomouc, Olomouc Region, Czechia
- České Budějovice, South Bohemian Region, Czechia
- Brno, South Moravian, Czechia
- Prague, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Liberec, Liberec Region, Czechia; Ostrava, Moravian-Silesian Region, Czechia; Třinec, Moravian-Silesian Region, Czechia; Olomouc, Olomouc Region, Czechia; České Budějovice, South Bohemian Region, Czechia; Brno, South Moravian, Czechia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.