Tachycardia, Ventricular, Ventricular Fibrillation
Conditions
Keywords
ATP, Thachy, FVT
Brief summary
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the painless therapy aspect of ICD treatment and improve quality of life outcomes for patients.
Detailed description
Main objective: Compare & quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88% Secondary objectives: * Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention * Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm * Compare the likelihood of syncopal events associated with spontaneous FVT episodes * Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes * Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.
Interventions
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease \[CAD\] or non-CAD in primary or secondary ICD prevention) * Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF
Exclusion criteria
* Patient's life expectancy less than 1 year due to a non-cardiac chronic disease * Patient on heart transplant list which is expected in \< 1 year * Patient's age less than 18 years * ICD replacements and upgrading (single chamber \[SC\] ICD® dual chamber \[DC\] ICD) * Unwillingness or inability to provide written informed consent * Enrollment in, or intention to participate in, another clinical study during the course of this study * Inaccessibility for follow-up at the study center * Ventricular tachyarrhythmias associated with reversible causes * Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients * Other electrical implantable devices (neurostimulators, etc.) * Mechanical tricuspid valve
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | one year | Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients. |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention | one year |
| Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms | one year |
| Percent Reduction in Shocks Delivered Per Patient for Treating FVT | one year |
| Compare Likelihood of Syncopal Events Associated With FVT | one year |
| Evaluate Different Possible Predictors of ATP Success | one year |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 8 Pulses Anti-Tachycardia Pacing (ATP) 8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) | 475 |
| 15 Pulses Anti-Tachycardia Pacing (ATP) 15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) | 450 |
| Total | 925 |
Baseline characteristics
| Characteristic | 8 Pulses Anti-Tachycardia Pacing (ATP) | 15 Pulses Anti-Tachycardia Pacing (ATP) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 261 Participants | 247 Participants | 508 Participants |
| Age, Categorical Between 18 and 65 years | 214 Participants | 203 Participants | 417 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 10.9 | 63.4 years STANDARD_DEVIATION 12.2 | 63.7 years STANDARD_DEVIATION 11.6 |
| Region of Enrollment Belgium | 8 participants | 7 participants | 15 participants |
| Region of Enrollment France | 84 participants | 77 participants | 161 participants |
| Region of Enrollment Germany | 109 participants | 106 participants | 215 participants |
| Region of Enrollment Israel | 9 participants | 6 participants | 15 participants |
| Region of Enrollment Italy | 180 participants | 169 participants | 349 participants |
| Region of Enrollment Portugal | 7 participants | 8 participants | 15 participants |
| Region of Enrollment Spain | 76 participants | 75 participants | 151 participants |
| Region of Enrollment United Kingdom | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 66 Participants | 48 Participants | 114 Participants |
| Sex: Female, Male Male | 409 Participants | 402 Participants | 811 Participants |
Outcome results
Primary
Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)
Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.
Time frame: one year
Population: 934 patients were created in the electronic data capture system, only 925 patients were enrolled in the study: 4 patients in the 8 pulses arm and 5 patients in the 15 pulses arm were created by mistake and excluded from analysis. The analysis were performed with the Intention To Treat (ITT) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 8 Pulses Anti-Tachycardia Pacing (ATP) | Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | 64.9 Percentage of FVT episodes terminated |
| 15 Pulses Anti-Tachycardia Pacing (ATP) | Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | 69.7 Percentage of FVT episodes terminated |
Secondary
Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms
Time frame: one year
Secondary
Compare Likelihood of Syncopal Events Associated With FVT
Time frame: one year
Secondary
Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention
Time frame: one year
Secondary
Evaluate Different Possible Predictors of ATP Success
Time frame: one year
Secondary
Percent Reduction in Shocks Delivered Per Patient for Treating FVT
Time frame: one year