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New treatment option for Symptomatic Bradycardia
Official title Basic and Clinical Study of Cardiac Ganglion Catheter Ablation for the Treatment of Significant Bradycardia
ClinicalTrials.gov ID: NCT07468383
What this study is testing
- What it's testing
- This study adopts a strategy combining basic research with clinical investigation to systematically explore the therapeutic value of cardioneuroablation in the treatment of vagally-mediated bradycardia. The study design fully considers the complexity of the scientific question and the feasibility of clinical translation.
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
- Age range: 18 - 65 years old
- Have symptoms related to bradycardia (syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate and decreased...
- Meet one of the following conditions: ①Dynamic electrocardiogram shows an average heart rate of less than 50 beats per minute or there is a heart...
- The atropine test showed that the sinus heart rate increased by ≥ 25%, or the heart rate was ≥ 90 beats per minute, or the atrioventricular...
You likely can't join if
- A history of severe trauma caused by bradycardia
- Regular use of antiarrhythmic drugs within the past 3 months
- Prior implantation of a cardiac pacemaker
- Existing implantation of, or indication for implantation of, electronic devices with pacing function, such as cardiac contractility modulators...
- Bradycardia or atrioventricular block caused by medications or other reversible factors (e.g., hyperkalemia, hypothyroidism)
- Bradycardia or atrioventricular block associated with obstructive sleep apnea syndrome (OSAS)
See the full eligibility criteria
- Age range: 18 - 65 years old
- Have symptoms related to bradycardia (syncope, dizziness, blackout, palpitations, fatigue, listlessness, inability to concentrate and decreased activity endurance, etc.)
- Meet one of the following conditions: ①Dynamic electrocardiogram shows an average heart rate of less than 50 beats per minute or there is a heart arrest lasting more than 3 seconds during the day; ②Transient second or...
- The atropine test showed that the sinus heart rate increased by ≥ 25%, or the heart rate was ≥ 90 beats per minute, or the atrioventricular conduction block was significantly improved to be no more than first-degree...
- A history of severe trauma caused by bradycardia
- Regular use of antiarrhythmic drugs within the past 3 months
- Prior implantation of a cardiac pacemaker
- Existing implantation of, or indication for implantation of, electronic devices with pacing function, such as cardiac contractility modulators (CCMs), implantable cardioverter-defibrillators (ICDs), or cardiac...
- Bradycardia or atrioventricular block caused by medications or other reversible factors (e.g., hyperkalemia, hypothyroidism)
- Bradycardia or atrioventricular block associated with obstructive sleep apnea syndrome (OSAS)
- Coronary revascularization within the past 3 months, or unstable coronary heart disease despite standardized medical treatment or revascularization
- Stroke or transient ischemic attack (TIA) within the past 3 months
- A history of open-heart surgery
- Severe congenital heart disease
- Complicated with severe ventricular arrhythmia
- Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) ≤ 35%
- Severe cardiomyopathy, such as hypertrophic obstructive cardiomyopathy (HOCM), dilated cardiomyopathy (DCM), or cardiac amyloidosis
- Severe aortic or mitral valve stenosis
- Pregnancy or lactation period
- Expected survival time of less than 1 year
- Refusal to sign the informed consent form
- Other conditions deemed ineligible by the researchers
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China, China
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 Beijing, China, China. 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.