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Study was terminated due to low accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Discontinuation of antiarrhythmic drugs | No Intervention | Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antiarrhythmic drug | Drug | Continuation of amiodarone or sotalol. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arvindh Kanagasundram, M.D | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Discontinuation of Antiarrhythmic Drugs | Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Discontinuation of Antiarrhythmic Drugs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | One year after ablation |
|
1 year
Chart review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Nervous system disorders | Non-systematic Assessment | Fatigue and asthenia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Giovanni Davogustto | Vanderbilt University Medical Center | 6159361720 | giovanni.e.davogustto@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2020 | Sep 29, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000889 | Anti-Arrhythmia Agents |
| D000638 | Amiodarone |
| D013015 | Sotalol |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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.
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| 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 |
Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cardiomyopathy type | Count of Participants | Participants |
|
| Left Ventricular Ejection Fraction (LVEF) | Median | Inter-Quartile Range | % |
|
|
|
| Secondary | All-cause Mortality | Deaths by any cause one year after ablation | Posted | Count of Participants | Participants | One year after ablation |
|
|
|
| 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 | Posted | Count of Participants | Participants | One year after ablation |
|
|
|
| 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 | Posted | Count of Participants | Participants | One year after ablation |
|
|
|
| Secondary | Number of Participants With Readmission for Heart Failure | Admissions with heart failure as principal diagnosis | Posted | Count of Participants | Participants | One year after ablation |
|
|
|
| Other Pre-specified | Number of Participants With Drug Side Effects | Side effects attributed to any drug of the patient's regimen | Posted | Count of Participants | Participants | One year after ablation |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 1 |
| 3 |
| EG001 | Discontinuation of Antiarrhythmic Drugs | Patients will stop class III antiarrhythmic drug they were receiving prior to the VT catheter ablation. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001572 |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |