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

NCT ID: NCT06455020

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-06-30

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.

Conditions

Ventricular Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Catheter ablation

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Stepped-care strategies

Intervention Type: PROCEDURE

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.

Interventions

Catheter ablation

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deyong Long, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

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

Countries

China

Central Contacts

Deyong Long, MD

Role: CONTACT

dragon2008@vip.sina.com

+86 (010) 84005361

Facility Contacts

Mengmeng Li

Role: primary

lmm6701@163.com

86+18610650190

Qiming Liu, MD

Role: primary

qimingliu@126.com

86+13873181753

Shaolong Li, MD

Role: primary

13700651472@126.com

86+13700651472

Jiangang Zou, MD

Role: primary

jgzou@njmu.edu.cn

86+13605191407

Other Identifiers

2024-vtstorm

Identifier Type: -

Identifier Source: org_study_id