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

NCT06455020 | Not Yet Recruiting DMC

• 1 other identifier: 2024-vtstorm
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

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).

Conditions

Ventricular Tachycardia

Keywords

Catheter ablation; Mortality; Electrical storm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Recurrence of ventricular tachycardia during the 30-day follow-up

  30 days

• Cardiovascular re-hospitalization during the 30-day follow-up

  30 days

• All-cause mortality during the 30-day follow-up

  30 days

• Composite outcomes of ventricular tachycardia recurrence, cardiovascular hospitalization, or death during the 1-year follow-up

  1 year

• All-cause mortality during the 1-year follow-up

  1 year

Study Arms (2)

Catheter ablation

EXPERIMENTAL

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

Stepped-care strategies

ACTIVE COMPARATOR

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

Interventions

Catheter ablation PROCEDURE

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

Catheter ablation

Stepped-care strategies 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.

Stepped-care strategies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (4)

Beijing Anzhen Hospital, Capital Medical University

Beijing, China

Location

Second Xiangya Hospital, Central South University

Changsha, China

Location

The Affiliated YanAn Hospital of KunMing Medical University

Kunming, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Deyong Long, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deyong Long, MD

CONTACT

+86 (010) 84005361; dragon2008@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)