To compare aggressive antiarrhythmic drug therapy to catheter ablation (ablation) for ventricular tachycardia (VT) in patients who have suffered prior myocardial infarction.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be a composite of death, appropriate ICD shock and VT
storm. Shocks and storm during a 1 month post-randomization treatment period
will be considered as secondary endpoints. Patients will be followed up for a
minimum of 3 years.
Secondary outcome
Secondary endpoints will include the following: all cause mortality,
appropriate ICD antitachycardia pacing anytime and after 1 month treatment
period, appropriate ICD shocks anytime and after 1 month treatment period, VT
storm anytime and after 1 month treatment period, documented sustained VT below
detection rate of the ICD any time and after 1 month treatment period,
inappropriate shocks anytime and after 1 month treatment period, number of ICD
shocks, hospital admission for cardiac causes, procedural complications,
amiodarone toxicity or adverse events, effects on ejection fraction,
quality of life/anxiety and cost-effectiveness.
Background summary
The most appropriate management for patients with implantable defibrillators
(ICDs) who experience recurrent ventricular arrhythmias is unknown. Standard
first-line therapy usually involves either sotalol or amiodarone. When patients
experience recurrent therapy despite these drugs, however, some clinicians
would advocate ablation as an alternative to more aggressive pharmacologic
therapy, while others would change or increase drug therapy. There is no
evidence to guide practice for this increasingly frequent clinical situation.
Study objective
To compare aggressive antiarrhythmic drug therapy to catheter ablation
(ablation) for ventricular tachycardia (VT) in patients who have suffered prior
myocardial infarction.
Study design
This trial will be a multicentre, parallel group, two arm, unblinded randomized
clinical trial.
Intervention
Group 1- Aggressive Antiarrhythmic Drug therapy. Patients randomized to
aggressive antiarrhythmic drug therapy will be treated with amiodarone or
amiodarone plus mexiletine.
Group 2- Catheter Ablation. Patients randomized to ablation will be scheduled
to undergo the procedure within 14 days, all induced VTs will be targeted for
ablation and patients will remain on the previously ineffective drug therapy
after the procedure.
Study burden and risks
Both catheter ablation and aggressive pharmacological management for recurrent
ventricular tachycardia are common clinical approaches, and there is clinical
equipoise between them. The only additional procedures required by the study
are quality of life questionnaires, echocardiography, blood work and
noninvasive testing. The risk of study participation, therefore, is no
different from usual standard care.
6513-1796 Summer St
B3H 3A7, Halifax, N.S.
CA
6513-1796 Summer St
B3H 3A7, Halifax, N.S.
CA
Listed location countries
Age
Inclusion criteria
1. Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)73
2. An implantable defibrillator
3. One of the following VT events (within last 3 months):
A: *3 episodes of symptomatic VT treated with antitachycardia pacing (ATP),
B: *1 appropriate ICD shocks,
C: *3 VT episodes within 24 hr
D: sustained VT below detection rate of the ICD documented by ECG/cardiac monitor
4. *Failed* first-line antiarrhythmic drug therapy (Class 1 or 3) as defined by one of:
A: Appropriate ICD therapy or sustained VT occurred while the patient was taking amiodarone (patient on a stable dose for * 2 weeks)
B: Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (patient on a stable dose for * 2 weeks)
Exclusion criteria
1. Are unable or unwilling to provide informed consent.
2. Have an acute coronary syndrome (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)
3. Are known to be ineligible to take amiodarone, e.g. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy.
4. Are ineligible for ablation (known to have protruding left ventricular thrombus, or have implanted mechanical aortic and mitral valves)
5. Are in renal failure (Creatinine clearance <15 ml/min)
6. Have current NYHA Functional class IV heart failure or CCS Functional class IV angina
7. Had recent ST elevation myocardial infarction (< 1 month)
8. Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<1 month)
9. Are pregnant
10. Have had prior ablation for ventricular tachycardia
11. Have a systemic illness likely to limit survival to < 1 year.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT#00905853 |
| CCMO | NL36631.058.11 |