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Tests treatment safety and results for Bradycardia
Official title Comparison of the Efficacy and Safety of Cardioneuroablation to Permanent Pacing in Patients With an Implanted Pacemaker for Symptomatic Bradycardia.
ClinicalTrials.gov ID: NCT05896592
What this study is testing
- What it's testing
- Background Sinus node dysfunction (SND) and atrioventricular block (AVB) are significant diagnostic and therapeutic problems. The primary method of their treatment is cardiac pacemaker implantation (PM).
- Which group you join is decided by chance.
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 65
You may be able to join if
- Patients who underwent pacemaker implantation before 50 years old due to sinus node and/or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18-65 years
- Signed informed consent to participate in the study
You likely can't join if
- Own heart rate \<30/min
- Fainting after pacemaker therapy initiation
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
- History of cardiac surgery
See the full eligibility criteria
- Patients who underwent pacemaker implantation before 50 years old due to sinus node and/or atrioventricular node dysfunction
- Positive response to atropine test
- Age between 18-65 years
- Signed informed consent to participate in the study
- Own heart rate \<30/min
- Fainting after pacemaker therapy initiation
- Persistent and sustained atrial fibrillation
- History of myocarditis
- History of myocardial infarction
- History of cardiac surgery
- History of ablation procedures
- Congenital heart defects
- Congenital atrioventricular block
- Neuromuscular and neurodegenerative diseases
- Indications for expanding the pacemaker system to ICD/CRT-D
- Pregnancy
- Renal insufficiency with GFR \<30 ml/min/1.73m2
- Age below 18 and above 65 years
- HAS-BLED score \>/= 3 points
The study team makes the final eligibility decision.
Where it's taking place
- Radom, Masovian Voivodeship, Poland
- Katowice, Silesian Voivodeship, Poland
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Radom, Masovian Voivodeship, Poland; Katowice, Silesian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
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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.