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 range18 Years – 75 Years
SexALL
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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…
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