Not Yet RecruitingNot Applicable

Cardiac Autonomic Nerve Improvement and Pacemaker Therapy in Patients With Sinus Bradycardia

240 participantsStarted 2021-09-01

Plain-language summary

This is a multicenter randomized controlled study. By comparing patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation and pacemaker therapy, and long-term follow-up to evaluate its safety and effectiveness after surgery, in order to evaluate the safety and effectiveness of cardiac autonomic ganglion ablation in the treatment of sinus bradycardia.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Aged 18 to 80 years old;
✓. Symptomatic sinus bradycardia;
✓. Not meet the class I indications for pacemaker implantation.

Exclusion criteria

✕. Structural heart disease, heart surgery history;
✕. Drug-induced SB, sinus pause \>2.0 s, positive atropine test, corrected sinus node recovery time (cSNRT) \>525 ms;
✕. Any atrial or ventricular arrhythmia, or a history of ablation procedures to treat atrial tachyarrhythmias;
✕. With Significant congenital heart disease, ejection fraction was \<40% measured by echocardiography;
✕. Allergic to contrast media;
✕. Contraindication to anticoagulation medications;
✕. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);

What they're measuring

Symptom score after operation

Timeframe: 48 months

Trial details

NCT IDNCT05021627

SponsorShanghai Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Xu Liu, MD

+8613052320103 heartlx@sina.com

View on ClinicalTrials.gov More Sinus Bradycardia trials