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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455020
• Other study ID #: 2024-vtstorm
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2024
• Source: Beijing Anzhen Hospital
• Contact: Deyong Long, MD
• Phone: +86 (010) 84005361
• Email: dragon2008[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 30-day follow-up	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.	30 days
Secondary	Recurrence of ventricular tachycardia during the 30-day follow-up	Recurrent ventricular tachycardia is defined as any appropriate implantable cardiac defibrillation therapy (shock or antitachycardia pacing) or documented sustained monomorphic ventricular tachycardia >30 seconds during the 30-day follow-up.	30 days
Secondary	Cardiovascular re-hospitalization during the 30-day follow-up	Cardiovascular re-hospitalization 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.	30 days
Secondary	All-cause mortality during the 30-day follow-up	All-cause mortality is defined as the death from all causes during the 30-day follow-up.	30 days
Secondary	Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up	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 1-year follow-up.	1 year
Secondary	All-cause mortality during the 1-year follow-up	All-cause mortality is defined as the death from all causes during the 1-year follow-up.	1 year