Heart Disease
Conditions
Keywords
Implantable Cardiac Defibrillator, therapies reduction, Shocks, Quality of Life
Brief summary
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.
Detailed description
Primary Objective: The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities. Secondary Objectives: 1. Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes. 2. Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study. 3. Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms. 4. Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms). 5. Describe the economic impact and the quality of life consequences.
Interventions
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
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
* Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines. * Previous implant of a Medtronic device including ATP During Charging feature for 15 days at the maximum.
Exclusion criteria
* ICD replacements and upgrading. * Brugada Syndrome, Long QT and HCM patients * Ventricular tachyarrhythmia associated with reversible cause. * Other electrical implantable devices (Neurostimulators, etc.). * Subject's life expectancy less than 1 year. * Subject on heart transplant list which is expected in less than 1 year. * Subject is \<18 years of age, or the subject is under a minimum age that is required as defined by local law * Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control. * Unwillingness or inability to provide written informed consent. * Enrolment in, or intention to participate in, another clinical trial. * Inaccessibility to come to the study center for the follow-up visits. * Mechanical tricuspid valve.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. | From enrollment to study completion or exit whichever occured first | for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed. The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times \* 100. |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes. | end of study |
Countries
Belgium, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Short NID Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia | 954 |
| Long NID Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia | 948 |
| Total | 1,902 |
Baseline characteristics
| Characteristic | Total | Long NID | Short NID |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1121 Participants | 558 Participants | 563 Participants |
| Age, Categorical Between 18 and 65 years | 781 Participants | 390 Participants | 391 Participants |
| Age, Continuous | 65.47 years STANDARD_DEVIATION 11.04 | 65.4 years STANDARD_DEVIATION 11 | 65.5 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment Belgium | 40 participants | 22 participants | 18 participants |
| Region of Enrollment Denmark | 23 participants | 14 participants | 9 participants |
| Region of Enrollment Finland | 5 participants | 2 participants | 3 participants |
| Region of Enrollment France | 123 participants | 62 participants | 61 participants |
| Region of Enrollment Germany | 112 participants | 60 participants | 52 participants |
| Region of Enrollment Hungary | 20 participants | 9 participants | 11 participants |
| Region of Enrollment Italy | 877 participants | 429 participants | 448 participants |
| Region of Enrollment Netherlands | 48 participants | 23 participants | 25 participants |
| Region of Enrollment Poland | 36 participants | 14 participants | 22 participants |
| Region of Enrollment Portugal | 53 participants | 30 participants | 23 participants |
| Region of Enrollment Russian Federation | 27 participants | 18 participants | 9 participants |
| Region of Enrollment Saudi Arabia | 90 participants | 45 participants | 45 participants |
| Region of Enrollment South Africa | 56 participants | 24 participants | 32 participants |
| Region of Enrollment Spain | 392 participants | 196 participants | 196 participants |
| Sex: Female, Male Female | 304 Participants | 153 Participants | 151 Participants |
| Sex: Female, Male Male | 1598 Participants | 795 Participants | 803 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 954 | 0 / 948 |
| serious Total, serious adverse events | 300 / 954 | 258 / 948 |
Outcome results
Primary
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.
for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed. The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times \* 100.
Time frame: From enrollment to study completion or exit whichever occured first
Population: For the primary endpoint analysis, only patients with at least a device data record were considered.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NID 18/24 | For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. | 67.1 rate of therapies per 100 patient-years |
| NID 30/40 | For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. | 41.9 rate of therapies per 100 patient-years |
p-value: <0.001Negative binomial regression
Secondary
Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.
Time frame: end of study