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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Procedure: Catheter ablation; Procedure: Stepped-care strategies

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deyong Long, MD; Phone Number: +86 (010) 84005361; Email: dragon2008@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Beijing AnZhen Hospital, Capital Medical University
    • Contact: Mengmeng Li; Phone Number: 86+18610650190; Email: lmm6701@163.com
  • Changsha, China
    • Second Xiangya Hospital, Central South University
    • Contact: Qiming Liu, MD; Phone Number: 86+13873181753; Email: qimingliu@126.com
  • Kunming, China
    • The Affiliated YanAn Hospital of KunMing Medical University
    • Contact: Shaolong Li, MD; Phone Number: 86+13700651472; Email: 13700651472@126.com
  • Nanjing, China
    • The First Affiliated Hospital of Nanjing Medical University
    • Contact: Jiangang Zou, MD; Phone Number: 86+13605191407; Email: jgzou@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter ablation; Patients randomized to the emergency catheter ablation arm will first undergo catheter ablation. Vasopressors, antiarrhythmic drugs, and hemodynamic mechanical support devices will be adopted as needed. All patients will be advised for ICD implantation before discharge.	Procedure: Catheter ablation; Emergency catheter ablation is defined as ablation performed within 48 hours of hospital admission
Active Comparator: Stepped-care strategies; Patients randomized to the stepped-care strategies arm will undergo a stepwise progressive procedure, with anti-arrhythmic drugs, sedation and anesthesia, and hemodynamic mechanical support devices, that is, the next treatment is only started when the previous sequence of treatment is ineffective, and catheter ablation is only used as the final rescue treatment. All patients will be advised for ICD implantation before discharge.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Investigators: Principal Investigator: Deyong Long, MD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Mortality; Catheter ablation; Electrical storm
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Diseases; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 2024-vtstorm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No