Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
The purpose of this study is to determine the safety and efficacy of the implant of a ICD lead of defibrillation in the septum of the right ventricle
Detailed description
The rate of success at implant and the positive clinical outcomes for the patients implanted with a lead of defibrillation at the septal site would make it possible to recommend this site as a new standard for implant of the defibrillation lead in the RV for ICD.
Interventions
DEVICEEndotak Reliance G
Reliance G is a defibrillation lead to be placed in the right ventricle.
Sponsors
Guidant Corporation
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ICD indication according to current Guidelines
Exclusion criteria
* Indication for cardiac resynchronisation therapy, absence of spontaneous ventricular rhythm, pacemaker dependency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Success Rate at Septal Site | At implant | Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold \< 1.5V, intrinsic amplitude \>3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of ATP Success Therapy | 3 months, 6 months, 12 months, 36 months, 60 months | in VT zone with at least one efficient ATP |
| - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 3 months, 6 months, 12 months, 36 months, 60 months | — |
| Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months | — |
| Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months | — |
| Evolution of Left Ventricular Ejection Fraction | 12 Months | LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mid Septal Site Location RV lead is placed at mid septum.
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | 107 |
| Apical Site Location RV lead is placed in apical position
Endotak Reliance G: Reliance G is a defibrillation lead to be placed in the right ventricle. | 108 |
| Total | 215 |
Baseline characteristics
| Characteristic | Mid Septal Site Location | Apical Site Location | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 12 | 59.1 years STANDARD_DEVIATION 12.7 | 59.7 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 16 Participants | 18 Participants | 34 Participants |
| Sex: Female, Male Male | 91 Participants | 90 Participants | 181 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 20 / 107 | 27 / 108 |
| other Total, other adverse events | 17 / 107 | 17 / 108 |
| serious Total, serious adverse events | 35 / 107 | 34 / 108 |
Outcome results
Primary
Implant Success Rate at Septal Site
Success of implant procedure: 1. implanted at the randomized site; 2. With electric criteria satisfied: pacing threshold \< 1.5V, intrinsic amplitude \>3 mV, impedance between 450 and 1800 Ω, shock impedance between 29 and 80 Ω and defibrillation at a maximum of 21J.
Time frame: At implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mid Septal Site Location | Implant Success Rate at Septal Site | 97 Participants |
| Apical Site Location | Implant Success Rate at Septal Site | 99 Participants |
Secondary
Evolution of Left Ventricular Ejection Fraction
LVEF at 12 months and the change in LVEF at 12 months compared to implant (in %)
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mid Septal Site Location | Evolution of Left Ventricular Ejection Fraction | LVEF at 12 Months | 41.96 Percentage of LVEF | Standard Deviation 13.81 |
| Mid Septal Site Location | Evolution of Left Ventricular Ejection Fraction | LVEF (%) Change from Implant | 5.66 Percentage of LVEF | Standard Deviation 11.96 |
| Apical Site Location | Evolution of Left Ventricular Ejection Fraction | LVEF at 12 Months | 40.57 Percentage of LVEF | Standard Deviation 14 |
| Apical Site Location | Evolution of Left Ventricular Ejection Fraction | LVEF (%) Change from Implant | 6.16 Percentage of LVEF | Standard Deviation 11.96 |
Secondary
Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment
Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Population: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | Discharge | 1 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 3 Months | 8 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 6 Months | 14 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 12 Months | 21 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 36 Months | 23 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 60 Months | 19 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 36 Months | 28 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | Discharge | 2 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 12 Months | 22 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 3 Months | 11 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 60 Months | 23 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Appropriate Treatment | 6 Months | 17 Participants |
Secondary
Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment
Time frame: Discharge, 3 Months, 6 Months, 12 Months, 36 Months, 60 Months
Population: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 6 Months | 3 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | Discharge | 0 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 3 Months | 4 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 12 Months | 9 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 36 Months | 8 Participants |
| Mid Septal Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 60 Months | 8 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 36 Months | 6 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 12 Months | 8 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | Discharge | 0 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 60 Months | 5 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 3 Months | 3 Participants |
| Apical Site Location | Spontaneous Episodes and Therapy Delivery - at Least One Inappropriate Treatment | 6 Months | 4 Participants |
Secondary
- The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value.
Time frame: 3 months, 6 months, 12 months, 36 months, 60 months
Population: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mid Septal Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 6 Months | 1 Participants |
| Mid Septal Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 36 Months | 2 Participants |
| Mid Septal Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 12 Months | 2 Participants |
| Mid Septal Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 60 Months | 4 Participants |
| Mid Septal Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 3 Months | 0 Participants |
| Apical Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 60 Months | 9 Participants |
| Apical Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 3 Months | 3 Participants |
| Apical Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 6 Months | 4 Participants |
| Apical Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 12 Months | 7 Participants |
| Apical Site Location | - The Number of Low Energy Shocks (at 11 Joules), Efficient in the VT Zone, in the Population Programmed at This Recommended Value. | 36 Months | 11 Participants |
Secondary
The Rate of ATP Success Therapy
in VT zone with at least one efficient ATP
Time frame: 3 months, 6 months, 12 months, 36 months, 60 months
Population: The number of participants analyzed per time frame is excluding those participants that have ended the study before the time frame or for whom visit data is missing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mid Septal Site Location | The Rate of ATP Success Therapy | 6 Months | 12 Participants |
| Mid Septal Site Location | The Rate of ATP Success Therapy | 36 Months | 23 Participants |
| Mid Septal Site Location | The Rate of ATP Success Therapy | 12 Months | 19 Participants |
| Mid Septal Site Location | The Rate of ATP Success Therapy | 60 Months | 17 Participants |
| Mid Septal Site Location | The Rate of ATP Success Therapy | 3 Months | 6 Participants |
| Apical Site Location | The Rate of ATP Success Therapy | 60 Months | 20 Participants |
| Apical Site Location | The Rate of ATP Success Therapy | 3 Months | 11 Participants |
| Apical Site Location | The Rate of ATP Success Therapy | 6 Months | 14 Participants |
| Apical Site Location | The Rate of ATP Success Therapy | 12 Months | 19 Participants |
| Apical Site Location | The Rate of ATP Success Therapy | 36 Months | 23 Participants |