Catheter Ablation, Tachycardia, Ventricular, Ventricular Tachycardia
Conditions
Keywords
ventricular tachycardia, catheter ablation, VT
Brief summary
The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.
Detailed description
Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.
Interventions
PROCEDUREcatheter-based ablation
specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia
Sponsors
Biosense Webster, Inc.
Vivek Reddy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 90 years. * History of coronary artery disease. * Presence of, or planned for, an ICD prior to discharge. * Presentation for management of ICD shock/ATP therapy or monomorphic ventricular tachycardia.
Exclusion criteria
* Ventricular arrhythmia not thought to be due to CAD. * Unstable angina * CVA within 30 days. * Protruding left ventricular thrombus or critical aortic stenosis on pre-ablation echocardiography * Pregnancy * Any condition resulting in an absolute contraindication to anticoagulation * Inability to follow-up at ICD clinic. * Inability to give informed consent. * Non-inducible for sustained monomorphic ventricular tachycardia. * Prior substrate guided ablation. * Definite need for epicardial ablation, as determined by the primary operator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter Ablation | at time of catheter ablation procedure (intraoperative) | The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICD Interrogation | baseline and 6 months follow-up | Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline. |
| Procedural Safety | 1 week post-op | 2\) Procedural safety as defined by the number of complication within 1week associated with the procedure. |
| Signal-Average ECG | baseline and post-op day one after procedure | Relationship between change in pre/post saECG and success of the step-wise ablation strategy |
Countries
Brazil, Canada, Czechia, Italy, United States
Participant flow
Recruitment details
Patients were recruited from 12/2011 to 7/2013, at a medical clinic at MSSM.
Participants by arm
| Arm | Count |
|---|---|
| Catheter-based Ablation catheter ablation - a medical procedure used to treat some types of arrhythmia | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Catheter-based Ablation |
|---|---|
| Age, Continuous | 61.75 years STANDARD_DEVIATION 7.18 |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 4 |
| serious Total, serious adverse events | 2 / 4 |
Outcome results
Primary
Catheter Ablation
The procedural efficacy as defined as acute success of a standardized step-wise approach for substrate-based catheter ablation of recurrent ventricular tachycardia in patients with coronary artery disease and prior ventricular tachycardia or appropriate therapy. Acute success will be defined as the ability to render VT non-inducible with a standardized complete stimulation protocol. catheter ablation - a medical procedure used to treat some types of arrhythmia
Time frame: at time of catheter ablation procedure (intraoperative)
Population: Given the small sample size, we did not analyze the data as there would be no statistical significance.
Secondary
ICD Interrogation
Chronic success will be defined as no recurrence of sustained VT or VT resulting in ICD therapies (ATP and/or ICD shocks) at 6 months follow-up as compared to baseline.
Time frame: baseline and 6 months follow-up
Secondary
Procedural Safety
2\) Procedural safety as defined by the number of complication within 1week associated with the procedure.
Time frame: 1 week post-op
Secondary
Signal-Average ECG
Relationship between change in pre/post saECG and success of the step-wise ablation strategy
Time frame: baseline and post-op day one after procedure