Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

NCT04512911 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 2019-10639
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success.

Conditions

Ventricular Tachycardia

Keywords

Ventricular tachycardia; Catheter ablation; Epicardial ablation; arrhythmia recurrence

Outcome Measures

Primary Outcomes (2)

• Freedom from documented VT episodes

  Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.

  12 months

• Freedom from documented VT episodes after second intervention

  Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.

  12 months after second intervention

Secondary Outcomes (5)

• Incidence of peri-procedural and 12-month post procedural complications,

  12 months

• Procedure duration and fluoroscopy time

  Up to 4 hours (During ablation procedure)

• Number of repeat procedures

  12, 24 months

• Cost-effectiveness analysis

  12 months

• Long-term follow-up to evaluate freedom of documented VT episodes

  24 and 60 months

Study Arms (2)

Patients who didn't fail AAD

ACTIVE COMPARATOR

This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications

Procedure: Endocardial ablation; Procedure: Endocardial- Epicardial ablation; Drug: Antiarrhythmic medications

Patients who failed AAD

ACTIVE COMPARATOR

This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation

Procedure: Endocardial ablation; Procedure: Endocardial- Epicardial ablation

Interventions

Endocardial ablation PROCEDURE

Endocardial ablation of VT

Patients who didn't fail AAD; Patients who failed AAD

Endocardial- Epicardial ablation PROCEDURE

Epicardial ablation of VT in addition to endocardial ablation

Patients who didn't fail AAD; Patients who failed AAD

Antiarrhythmic medications DRUG

Addition of anti arrhythmic medication or dose increase

Patients who didn't fail AAD

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or greater
• Patient with ≥ 1 episode of VT (i.e., Sustained VT more than 30 seconds or VT with any ICD therapy)
• Patients with ischemic cardiomyopathy, EF less than 50%, documented history of CAD

You may not qualify if:

• Patients with ventricular fibrillation.
• Reversible causes of VT.
• Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.
• Patients with prior procedure involving opening the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) were adhesions are suspected
• Any prior ablation for the ventricles or any prior epicardial ablation
• Documented history of myocardial infarction within 1 month prior to the planned study intervention
• Documented symptomatic carotid disease defined as \> 70% stenosis or \> 50% stenosis with symptoms
• Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer
• Active pericarditis
• Active endocarditis\\Any documented history or autoimmune disease associated with pericarditis
• Thrombocytopenia (platelet count \< 100 x 109/L)
• Body Mass Index (BMI \> 45)
• Patients who are pregnant.
• Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center, Cardiology

The Bronx, New York, 10467, United States

Location

Related Publications (39)

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MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

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

Study Officials

• Jorge Romero, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Luigi Di Biase, MD

  Montefiore Medical Center/Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the ablation procedures and medications treatment assignment, physicians and patients cannot be blinded to the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 100 patients will be randomized in 1:1 fashion to investigation arms Endocardial - Epicardial (20 patients) or Endocardial ablation (20 patients) if patients have previously failed AAD and in 1:1:1 fashion randomization to Endocardial - Epicardial ablation (20 patients), Endocardial ablation (20 patients) and AAD (20 patients) if patients have not failed AAD previously. If during follow up VT recurrence occurs, treatment method that patient was assigned to will be considered failed and patients will undergo redo ablation (same as previously assigned to) or if AAD failed patient will be added a second AAD or changed to another AAD. If during follow up after second procedure or adjustment of AAD patient experiences VT recurrence the treatment method will be considered failed.

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 14, 2020
• Study Start: January 1, 2023
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)