UnknownNot Applicable

Cardiac Denervation Ablation Strategy for Severe Sinus Bradycardia

China88 participantsStarted 2023-09-13

Plain-language summary

This is a prospective clinical observation and registration study. The investigator aimed to evaluate the efficacy and safety of cardiac denervation ablation as a treatment strategy for severe sinus bradycardia.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Sinus bradycardia and pacemaker implantation indication: long interval with mean heart rate \<45 bpm or 3s recorded within 6 months before inclusion;
✓. Negative atropine test: sinus heart rate\> 90bpm after atropine injection
✓. SSB related symptoms: dizziness, palpitations, fatigue, amaurosis, syncope, etc.
✓. Age ≥18 and \<60 years old;
✓. The patient has agreed to participate in this trial and has signed the informed consent form.

Exclusion criteria

✕. Previous history of atrial arrhythmia ablation or surgical procedure;
✕. Structural heart disease, chronic liver and kidney dysfunction, diabetes mellitus, neurological diseases.;
✕. Drug-related SSB;
✕. presence of left atrial thrombus;
✕. Pregnant women.

What they're measuring

Number of patients with postoperative recurrence of bradycardia symptoms

Timeframe: 12 months after ablation procedure

Trial details

NCT IDNCT06276816

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-09-30

Contact for this trial

yan Yao, PhD

13901121319 ianyao@263.net.cn

View on ClinicalTrials.gov More Sinus Bradycardia trials