Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction (NCT05196126) | Clinical Trial Compass
UnknownNot Applicable
Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction
Poland60 participantsStarted 2022-06-01
Plain-language summary
This is a noncommercial, physician-initiated, monitored, multicenter, prospective randomized clinical trial, a proof-of-concept study, investigating a treatment strategy only. The study will use medical products applied for invasive and nonivasive procedures performed at the participating centers.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age, 18-75 years
* Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
* Optimization of chronic disease treatment
* Ability to provide informed consent to participate in the study
* Ability to understand patient information.
Exclusion Criteria:
* Contraindications to invasive and noninvasive procedures used in the study
* Uncontrolled endocrine and systemic disorders
* Persistent atrial fibrillation
* Dilated cardiomyopathy
* Severe congenital heart valve disease or cardiomyopathy
* Functional NYHA class III/IV
* Left ventricular ejection fraction \<35%
* Left atrial diameter \>50 mm
* Previous catheter ablation
* Contraindications to anticoagulant treatment
* Contraindications to catheter ablation
* Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease
* Contraindications to noninvasive tests
* Pregnancy and lactation
* Previous cardiac surgery
* Implanted pacemaker device
* Neck and chest abnormalities
* Myocardial infarction in the previous 6 months
* Percutaneous coronary intervention in the previous 3 months
* Estimated survival \<24 months
* Participation in another drug or medical device program
* Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study.
* Any other uncontrolled chronic diseases, neck and chest abnormalities, or dis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Had Freedom From Bradycardia Symptoms at 6 months
Timeframe: 6 months
2
Number of Participants with Pacemaker Implantation at 6 months