Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation (AFTER-VT)

Continuation of Antiarrhythmics Following caThEteR Ablation for Ventricular Tachycardia (AFTER-VT) Trial: A Pilot Randomized Clinical Trial

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.

Study Overview

• Status: Terminated
• Conditions: Tachycardia, Ventricular; Catheter Ablation
• Intervention / Treatment: Drug: Antiarrhythmic drug

Detailed Description

Catheter ablation is a valuable option to control recurrent Ventricular Tachycardia (VT) in patients with structural heart disease. A recent trial proved that catheter ablation is superior to escalation of anti arrhythmic drugs (AADs) in prevention of VT recurrence and death (Sapp et al. N Engl J Med 2016; 375:111-121). However, even with ablation, approximately 20-50% of patients will have an episode of VT within one year. This is probably explained in part by the substrate (myocardial scar from cardiomyopathy) persists after VT ablation and that ablation lesions heal and evolve over days, weeks and even months. Most patients (if not all) of patients who undergo ablation are on AADs and usually have failed at least one of them. Furthermore, most AADs, and Vaughan Williams class III AADs in particular (the most frequently used to treat VT) carry significant and life-threatening side effects from pulmonary, hepatic and hematologic toxicities up to significant ventricular arrhythmias and death. Since these patients have already failed AADs, and the significant adverse profile of AADs, there is no evidence that the benefits of continuation of these drugs will surpass the risks after ablation. Therefore the investigators decided to ask the question:

Among patients with structural heart disease who undergo VT ablation, does continuation of class III AADs for 3 months, increases VT-free survival compared to discontinuation of antiarrhythmic drug therapy?

Based on expert consensus about clinical equipoise in regards of AAD continuation after VT ablation, the investigators decided to select patients with lowest risk of VT recurrence after ablation as our study population. The investigators aim to include in our study only those patients who have an Implantable Cardioverter-Defibrillator (ICD), who have NO inducible VT at the end of the ablation procedure and also who have NO inducible VT prior to discharge on a procedure called non-invasive programmed stimulation (NIPS). It has been shown that patients with inducible VT at the end of ablation and during NIPS have significantly higher risk of VT recurrence compared to those in whom VT was not induced. In NIPS, one uses the previously Implanted ICD to pace the ventricle fast enough to try to induce VT. Both procedures will be performed as usual practice in patients who undergo VT ablation in the arrhythmia service.

The specific aim of this pilot study is to evaluate whether the strategy of continuation of class III AADs following initial catheter ablation for VT, improves VT-free survival and reduces readmissions.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuation of antiarrhythmic drugs; 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; Continuation of amiodarone or sotalol.; Other Names: Amiodarone; Sotalol
No Intervention: Discontinuation of antiarrhythmic drugs; Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Mortality	Deaths by any cause one year after ablation	One year after ablation
Number of Participants With VT Recurrence	Self-terminating sustained VTs (>30 seconds or hemodynamic instability) and VT requiring ICD device therapies for termination (appropriate therapies) will be considered VT recurrences	One year after ablation
Number of Participants With VT/Electrical Storm	Three or more episodes of sustained VT, ventricular fibrillation, or appropriate ICD therapies within a 24-hour period	One year after ablation
Number of Participants With Readmission for Heart Failure	Admissions with heart failure as principal diagnosis	One year after ablation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Drug Side Effects	Side effects attributed to any drug of the patient's regimen	One year after ablation

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Arvindh Kanagasundram, M.D, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Catheter Ablation; Ventricular Tachycardia; Antiarrhythmic drugs
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Sympatholytics; Potassium Channel Blockers; Amiodarone; Sotalol; Anti-Arrhythmia Agents
• Other Study ID Numbers: 191113

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No