Skip to content

Continuation of Antiarrhythmics Following Ventricular Tachycardia Catheter Ablation

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04208997
Acronym
AFTER-VT
Enrollment
5
Registered
2019-12-23
Start date
2019-12-19
Completion date
2021-06-30
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tachycardia, Ventricular, Catheter Ablation

Keywords

Ventricular Tachycardia, Catheter Ablation, Antiarrhythmic drugs

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.

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.

Interventions

Continuation of amiodarone or sotalol.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Dead or With VT Recurrence at One YearOne year after ablationA composite of all-cause mortality and VT recurrence one year after index VT ablation

Secondary

MeasureTime frameDescription
All-cause MortalityOne year after ablationDeaths by any cause one year after ablation
Number of Participants With VT RecurrenceOne year after ablationSelf-terminating sustained VTs (\>30 seconds or hemodynamic instability) and VT requiring ICD device therapies for termination (appropriate therapies) will be considered VT recurrences
Number of Participants With VT/Electrical StormOne year after ablationThree or more episodes of sustained VT, ventricular fibrillation, or appropriate ICD therapies within a 24-hour period
Number of Participants With Readmission for Heart FailureOne year after ablationAdmissions with heart failure as principal diagnosis

Other

MeasureTime frameDescription
Number of Participants With Drug Side EffectsOne year after ablationSide effects attributed to any drug of the patient's regimen

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Antiarrhythmic drug: Continuation of amiodarone or sotalol.
3
Discontinuation of Antiarrhythmic Drugs
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation.
2
Total5

Baseline characteristics

CharacteristicDiscontinuation of Antiarrhythmic DrugsTotalContinuation of Antiarrhythmic Drugs
Age, Continuous69.1 years64 years61.2 years
Cardiomyopathy type
Dilated cardiomyopathy
0 Participants0 Participants0 Participants
Cardiomyopathy type
Ischemic cardiomyopathy
2 Participants5 Participants3 Participants
Left Ventricular Ejection Fraction (LVEF)42.5 %30 %25 %
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants5 Participants3 Participants
Region of Enrollment
United States
2 participants5 participants3 participants
Sex: Female, Male
Female
0 Participants1 Participants1 Participants
Sex: Female, Male
Male
2 Participants4 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 30 / 2
other
Total, other adverse events
1 / 30 / 2
serious
Total, serious adverse events
0 / 30 / 2

Outcome results

Primary

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

Time frame: One year after ablation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Continuation of Antiarrhythmic DrugsNumber of Participants Dead or With VT Recurrence at One Year0 Participants
Discontinuation of Antiarrhythmic DrugsNumber of Participants Dead or With VT Recurrence at One Year0 Participants
Secondary

All-cause Mortality

Deaths by any cause one year after ablation

Time frame: One year after ablation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Continuation of Antiarrhythmic DrugsAll-cause Mortality0 Participants
Discontinuation of Antiarrhythmic DrugsAll-cause Mortality0 Participants
Secondary

Number of Participants With Readmission for Heart Failure

Admissions with heart failure as principal diagnosis

Time frame: One year after ablation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Continuation of Antiarrhythmic DrugsNumber of Participants With Readmission for Heart Failure0 Participants
Discontinuation of Antiarrhythmic DrugsNumber of Participants With Readmission for Heart Failure0 Participants
Secondary

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

Time frame: One year after ablation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Continuation of Antiarrhythmic DrugsNumber of Participants With VT/Electrical Storm0 Participants
Discontinuation of Antiarrhythmic DrugsNumber of Participants With VT/Electrical Storm0 Participants
Secondary

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

Time frame: One year after ablation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Continuation of Antiarrhythmic DrugsNumber of Participants With VT Recurrence0 Participants
Discontinuation of Antiarrhythmic DrugsNumber of Participants With VT Recurrence0 Participants
Other Pre-specified

Number of Participants With Drug Side Effects

Side effects attributed to any drug of the patient's regimen

Time frame: One year after ablation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Continuation of Antiarrhythmic DrugsNumber of Participants With Drug Side Effects1 Participants
Discontinuation of Antiarrhythmic DrugsNumber of Participants With Drug Side Effects0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026