Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation

NCT04208997 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 191113
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to study if patients that undergo catheter ablation for ventricular tachycardia benefit from continuation of Vaughan-Williams class III antiarrhythmic drugs for 3 months after their ablation.

Conditions

Tachycardia, Ventricular; Catheter Ablation

Keywords

Ventricular Tachycardia; Catheter Ablation; Antiarrhythmic drugs

Outcome Measures

Primary Outcomes (1)

• Number of Participants Dead or With VT Recurrence at One Year

  A composite of all-cause mortality and VT recurrence one year after index VT ablation

  One year after ablation

Secondary Outcomes (4)

• All-cause Mortality

  One year after ablation

• Number of Participants With VT Recurrence

  One year after ablation

• Number of Participants With VT/Electrical Storm

  One year after ablation

• Number of Participants With Readmission for Heart Failure

  One year after ablation

Other Outcomes (1)

• Number of Participants With Drug Side Effects

  One year after ablation

Study Arms (2)

Continuation of antiarrhythmic drugs

EXPERIMENTAL

Patients will continue the class III antiarrhythmic drug they were receiving prior the VT catheter ablation for 3 months after the ablation.

Drug: Antiarrhythmic drug

Discontinuation of antiarrhythmic drugs

NO INTERVENTION

Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.

Interventions

Antiarrhythmic drug DRUG

Continuation of amiodarone or sotalol.

Also known as: Amiodarone, Sotalol

Continuation of antiarrhythmic drugs

Eligibility Criteria

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

You may qualify if:

• Age \>18 years.
• Able to give written, informed consent
• Structural heart disease.
• Implanted and normally functioning ICD or undergoing ICD implant at index admission.
• Undergoing initial radiofrequency ablation procedure for sustained monomorphic VT.
• Receiving a class III AADs prior to VT ablation.
• No VT inducible at the end of VT ablation.
• No VT inducible on non-invasive programmed stimulation following VT ablation.

You may not qualify if:

• LV assist device in place
• Decompensated heart failure and/or requiring continuous inotropic therapy and/or awaiting cardiac transplantation
• Ongoing acute coronary syndrome.
• Mechanical prosthetic aortic and mitral valves.
• Pedunculated or mobile left ventricular thrombus.
• Persistent VT at the end of index catheter ablation.
• Absolute contraindications for class III AADs.
• Participation in other trial.
• VT induced on NIPS after VT ablation.
• Another reason for continuation of class III AADs (i.e., atrial fibrillation).

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Anti-Arrhythmia Agents; Amiodarone; Sotalol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr Giovanni Davogustto
• Organization: Vanderbilt University Medical Center

giovanni.e.davogustto@vumc.org

6159361720

Study Officials

• Arvindh Kanagasundram, M.D

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Patients that meet inclusion criteria and agree to participate will be randomized and allocated to continue class III AADs or discontinuation using block randomization, stratified by type of AADs and type of cardiomyopathy (ischemic vs nonischemic) used until goal enrollment is achieved. The randomization sequence was created using STATA 14.2 (StataCorp, College Station, TX, USA) statistical software.

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: December 19, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 14, 2022
• Results First Posted: November 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)