Clinical trial NCT06455020: Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
Official title: Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Catheter ablation
Mortality
Electrical storm
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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 outcomes:
measure: Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up
timeFrame: 30 days
Secondary outcomes:
measure: Recurrence of ventricular tachycardia during the 30-day follow-up
timeFrame: 30 days
measure: Cardiovascular re-hospitalization during the 30-day follow-up
timeFrame: 30 days
measure: All-cause mortality during the 30-day follow-up
timeFrame: 30 days
measure: Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up
timeFrame: 1 year
measure: All-cause mortality during the 1-year follow-up
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Changsha
country: China
facility: Second Xiangya Hospital, Central South University
city: Kunming
country: China
facility: The Affiliated YanAn Hospital of KunMing Medical University
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Deyong Long, MD
role: PRINCIPAL_INVESTIGATOR
References: