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Clinical Trials in China / NCT06455020
Starting soon Not applicable

Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease

NCT06455020 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Anzhen Hospital
Phase
Not applicable
Started
2024-07-01
Last updated
2024-06-12

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

Catheter ablationStepped-care strategies

Catheter ablation: Emergency catheter ablation is defined as ablation performed within 48 hours of hospital admission

Stepped-care strategies: Patients randomized to the stepped-care strategy arm will receive treatment through a systematic, stepwise protocol beginning with anti-arrhythmic drugs, followed by sedation and anesthesia, and progressing to haemodynamic mechanical support devices if earlier treatments prove ineffective. Catheter ablation will be reserved as the final rescue intervention.

Study summary

This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients aged 18 to 80 years; 2. Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy; 3. Haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure \<90 mmHg and mean arterial pressure 30 mmHg lower than baseline or \<70 mmHg, with associated signs of end-organ hypoperfusion); 4. Electrical storm, defined as \>3 VT episodes within 24 hours. Exclusion Criteria: 1. Reversible causes of ventricular tachycardia or cardiomyopathy; 2. Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance; 3. Acute ST-segment-elevation myocardial infarction within 60 days; 4. Cardiac surgery within 60 days; 5. Unstable angina; 6. Pregnancy.

Primary outcome measure(s)

  • Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up — 30 days
    Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia \>30 seconds. Cardiovascular rehospitalization is defined as a hospital admission after the randomly assigned procedure for heart failure, procedure-associated complications, or arrhythmic causes during the 30-day follow-up.

Trial sites (4)

FacilityCityRegionStatus
Beijing Anzhen Hospital, Capital Medical University Beijing China
Second Xiangya Hospital, Central South University Changsha China
The Affiliated YanAn Hospital of KunMing Medical University Kunming China
The First Affiliated Hospital of Nanjing Medical University Nanjing China

More Beijing Anzhen Hospital trials in China

Arrhythmia Cohort Study Starting soon
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation Active, not recruiting
Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation Recruiting
Genotyping GUided Antiplatelet theRapy in pAtieNts Treated With Drug Eluting stEnts (GUARANTEE) Active, not recruiting
The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism Active, not recruiting

Other trials for the same condition

CHU Dual-Energy Ablation in Ventricular Arrhythmia Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06455020 on ClinicalTrials.gov ↗ ← All trials in China