Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Catheter ablation, Stepped-care strategies.
- Who it may be relevant to
- Registry conditions: Ventricular Tachycardia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Detailed description
The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor, with a high 30-day mortality rate \>30%, resulting in extremely heavy medical burden. Current guidelines lack specific recommendations for managing this condition. The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. Catheter ablation is only used as the final rescue treatment. Typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. Studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. Early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT. Therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia.
In this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. Current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. The follow-up duration is 1 year. The primary outcome is a composite outcome of VT recurrence, cardiovascular re-hospitalization, and all-cause mortality.
Interventions
- Procedure Catheter ablation
Emergency catheter ablation is defined as ablation performed within 48 hours of hospital admission - Procedure 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.
Primary outcome measures
- Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up [Time frame: 30 days]
Secondary outcome measures (5)
- Recurrence of ventricular tachycardia during the 30-day follow-up [Time frame: 30 days]
- Cardiovascular re-hospitalization during the 30-day follow-up [Time frame: 30 days]
- All-cause mortality during the 30-day follow-up [Time frame: 30 days]
- Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up [Time frame: 1 year]
- All-cause mortality during the 1-year follow-up [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients aged 18 to 80 years;
- Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy;
- 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);
- Electrical storm, defined as >3 VT episodes within 24 hours.
Exclusion criteria
- Reversible causes of ventricular tachycardia or cardiomyopathy;
- Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance;
- Acute ST-segment-elevation myocardial infarction within 60 days;
- Cardiac surgery within 60 days;
- Unstable angina;
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- Second Xiangya Hospital, Central South University — Changsha
- The Affiliated YanAn Hospital of KunMing Medical University — Kunming
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06455020 · 2024-vtstorm