Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation on the Long Term Success Rate of VT Ablation
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/5/2014 |
| Start Date: | January 2010 |
| End Date: | December 2014 |
| Contact: | Luigi Di Biase, MD |
| Email: | dibbia@gmail.com |
| Phone: | 512-423-9855 |
Comparison of the Effect of Ablation of the Clinically Presenting Ventricular Tachycardia (VT) Only Versus the Addition of Substrate Ablation Based on Scar Mapping; on the Long Term Success Rate of VT Ablation
This study aims to assess whether a combined technique of substrate ablation and ablation of
the clinically presenting VT at the site of early activation is superior to ablation of the
clinically presenting VT alone, in enhancing long-term success of VT ablation.
the clinically presenting VT at the site of early activation is superior to ablation of the
clinically presenting VT alone, in enhancing long-term success of VT ablation.
Background: VT is found mostly in patients with structural heart disease. It is classified
using morphological criteria (monomorphic or polymorphic), duration of arrhythmia (sustained
or non-sustained) or the mechanism of arrhythmia formation (re-entry, increased automation
or triggered activity). The therapeutic approach and prognostic estimates of these different
types of VT depend to a great degree on the mechanistic basis of the disease as well as the
extent of myocardial damage and success of the therapy is measured by the absence of
recurrence.
Myocardial infarction with subsequent induction of VT is observed as a consequence of
coronary artery disease (CAD). The infarct regions that are morphologically and electrically
diseased can be arrhythmogenic and may form the substrate for macro-reentrant VT.
Although antiarrhythmic drugs remain the primary form of therapy for VT, non-pharmacologic
techniques like implantable cardioverter-defibrillator (ICD) and catheter ablation (CA) are
becoming increasingly popular because of advancement in technology as well as an increase in
desire among patients to eliminate the arrhythmia with ablation rather than suppressing it
with drugs. ICDs and CA effectively terminate VT on a short-term basis; but multiple
morphologies, hemodynamic instability and non-inducibility limit the long-term success rate
of CA. The 'substrate mapping' approach defines areas of ventricular scar which can be
potential VT sources. Several studies on small groups of patients have shown that successful
ablation of VT substrates either reduces the recurrence of VT to 19- 50% or reduces the
frequency of recurrence as well as the requirement of anti-arrhythmic drugs (AADs).
Study design:
This study is a multicenter, randomized, open label, parallel-arm clinical trial. A total
of 120 post-myocardial infarction patients will be randomized at a 1:1 ratio into 2 groups:
1. ablation targeting the clinically presenting VT at the site of early activation only,
or
2. ablation targeting the clinically presenting VT at the site of early activation plus
substrate-based RF ablation
Follow-up:
Patients will undergo ICD interrogation at 3, 6 and 12 months to collect VT episode data, VT
symptom assessment, complication assessment and AAD records. Management of AADs will be at
the discretion of the physician.
using morphological criteria (monomorphic or polymorphic), duration of arrhythmia (sustained
or non-sustained) or the mechanism of arrhythmia formation (re-entry, increased automation
or triggered activity). The therapeutic approach and prognostic estimates of these different
types of VT depend to a great degree on the mechanistic basis of the disease as well as the
extent of myocardial damage and success of the therapy is measured by the absence of
recurrence.
Myocardial infarction with subsequent induction of VT is observed as a consequence of
coronary artery disease (CAD). The infarct regions that are morphologically and electrically
diseased can be arrhythmogenic and may form the substrate for macro-reentrant VT.
Although antiarrhythmic drugs remain the primary form of therapy for VT, non-pharmacologic
techniques like implantable cardioverter-defibrillator (ICD) and catheter ablation (CA) are
becoming increasingly popular because of advancement in technology as well as an increase in
desire among patients to eliminate the arrhythmia with ablation rather than suppressing it
with drugs. ICDs and CA effectively terminate VT on a short-term basis; but multiple
morphologies, hemodynamic instability and non-inducibility limit the long-term success rate
of CA. The 'substrate mapping' approach defines areas of ventricular scar which can be
potential VT sources. Several studies on small groups of patients have shown that successful
ablation of VT substrates either reduces the recurrence of VT to 19- 50% or reduces the
frequency of recurrence as well as the requirement of anti-arrhythmic drugs (AADs).
Study design:
This study is a multicenter, randomized, open label, parallel-arm clinical trial. A total
of 120 post-myocardial infarction patients will be randomized at a 1:1 ratio into 2 groups:
1. ablation targeting the clinically presenting VT at the site of early activation only,
or
2. ablation targeting the clinically presenting VT at the site of early activation plus
substrate-based RF ablation
Follow-up:
Patients will undergo ICD interrogation at 3, 6 and 12 months to collect VT episode data, VT
symptom assessment, complication assessment and AAD records. Management of AADs will be at
the discretion of the physician.
Inclusion Criteria:
- Previous Myocardial infarction
- Symptomatic, drug-refractory and haemodynamically stable VT following CAD
- Undergoing a VT ablation
- Implanted ICD
Exclusion Criteria:
- Documented valvular heart disease
- Acute myocardial infarction within the preceding 1 month
- Unstable angina
- Prolonged QT interval
- Patients with hemorrhagic or thrombophilic disorders
- Documented intra-atrial thrombus, tumor or other conditions which prevent easy
catheter introduction
We found this trial at
1
site
Click here to add this to my saved trials
