Time to recurrence of sustained VT and/or appropriate ICD therapy; ATP or shock
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the assessment of recurrences of sustained VT (longer that 30 seconds or with
hemodynamic instability) or VF with or without ICD therapy for VT or VF after
appropriate ICD therapy (ATP or shock) in patients with a history of a
myocardial infarction undergoing substrate based ablation compared to patients
treated with amiodarone alone.
Secondary outcome
Time to recurrence of sustained VT (longer that 30 seconds or with hemodynamic
instability) or VF with or without documented ICD therapy (shock or ATP) for
VT of VF during the follow-up period starting post ablation or after receiving
amiodarone.
Background summary
Increasing numbers of patients with coronary artery disease (CAD) are treated
with an implantable cardioverter defibrillator (ICD). One of the major concerns
after implantation is prevention of ventricular tachycardia (VT) or ventricular
fibrillation (VF ) and management of the ventricular rhythm disturbances by ICD
therapy. Radiofrequency ablation and/or anti arrhythmic medication are both
used to prevent recurrences of shock therapy. However, both therapies were
never evaluated in a randomized clinical trial in patients with a myocardial
scar after a myocardial infarction. We hypothesize that substrate modification
may prolong the time to next episode of sustained VT (longer than 30 seconds or
with hemodynamic instability) or VF with or without ICD intervention and may
also reduce the total number of ICD intervention.
The primary purpose of this randomized study is the assessment of recurrences
of sustained VT (longer that 30 seconds or with hemodynamic instability) or VF
with or without ICD therapy for VT or VF after appropriate ICD therapy (ATP or
shock) in patients with a history of a myocardial infarction undergoing
substrate based ablation compared to patients treated with amiodarone alone
Study objective
Time to recurrence of sustained VT and/or appropriate ICD therapy; ATP or shock
Study design
Single-center, prospective, randomized, open trial
Intervention
undergoing substrate based ablation compared to patients treated with
amiodarone alone
Study burden and risks
NAP
v Nahuysplein 6
8011 NB
Nederland
v Nahuysplein 6
8011 NB
Nederland
Listed location countries
Age
Inclusion criteria
1. prior myocardial infarction, at least 3 months ago
2. ICD implantation
3. ICD shock or ATP for VT or VF without a reversible cause reversible causes
4. Optimal revascularization before ICD implantation performed
Exclusion criteria
1. Age < 18 years
2. use of amiodarone more than 7 days before randomization within the period of 3 months before randomization
3. Inability to use amiodarone due to past side effects
4. Class I antiarrythmic drugs not stopped <= 5 times *T prior to randomization
5. Protruding LV thrombus or cardiac tumor on pre-ablation echocardiogram
6. non-reversible Class IV NYHA heart failure
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2011-001141-32-NL |
| CCMO | NL36076.075.11 |