Tachycardia, Ventricular, Ventricular Fibrillation
Conditions
Keywords
ATP, Tachycardia, CRT-D
Brief summary
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation. The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.
Detailed description
Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in favour of BIV ATP Secondary objectives: * Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast ventricular tachycardia (FVT) * Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow ventricular tachycardia (slow VT) * Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular tachycardia (slow VT) * Determine the rate of both FVT and VT episodes which are accelerated or degenerates into VF
Interventions
Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window
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
* CRT + ICD indications (Class I-IIA) according to the guidelines * Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP * Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD
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 * Replacements and upgrades * Epicardial lead * Mechanical tricuspid valve * Ventricular Tachyarrhythmias associated with reversible causes * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. | 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 |
|---|---|
| Compare Efficacy of the First BiV and RV ATP to Terminate FVT | one year |
| Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT | one year |
| Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT | one year |
| Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF | one year |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Right Ventricle (RV) Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle | 266 |
| Biventricular (BiV) Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles | 260 |
| Total | 526 |
Baseline characteristics
| Characteristic | Total | Biventricular (BiV) | Right Ventricle (RV) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 337 Participants | 165 Participants | 172 Participants |
| Age, Categorical Between 18 and 65 years | 189 Participants | 95 Participants | 94 Participants |
| Age, Continuous | 66.7 years STANDARD_DEVIATION 9.8 | 66.8 years STANDARD_DEVIATION 9.5 | 66.6 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment France | 128 participants | 61 participants | 67 participants |
| Region of Enrollment Germany | 94 participants | 46 participants | 48 participants |
| Region of Enrollment Israel | 9 participants | 4 participants | 5 participants |
| Region of Enrollment Italy | 249 participants | 127 participants | 122 participants |
| Region of Enrollment Portugal | 2 participants | 1 participants | 1 participants |
| Region of Enrollment Spain | 42 participants | 20 participants | 22 participants |
| Region of Enrollment United Kingdom | 2 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 77 Participants | 42 Participants | 35 Participants |
| Sex: Female, Male Male | 449 Participants | 218 Participants | 231 Participants |
Outcome results
Primary
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Right Ventricle (RV) | Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. | 64.7 Percent of VT episodes terminated |
| Biventricular (BiV) | Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. | 68.2 Percent of VT episodes terminated |
Secondary
Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT
Time frame: one year
Secondary
Compare Efficacy of the First BiV and RV ATP to Terminate FVT
Time frame: one year
Secondary
Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT
Time frame: one year
Secondary
Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF
Time frame: one year