Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks. The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death. It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.
Interventions
Implantable defibrillator to detect and terminate ventricular arrhythmias
Sponsors
Guidant Corporation
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients undergoing initial implant of an ICD or CRT-D device (can be upgrade from a pacemaker)
Exclusion criteria
* Patients, who in the opinion of their treating physicians are ineligible for either strategy (DT or no DT) * Patients on active transplant list * Patients unwilling to provide informed consent * Patients not available for follow-up * Pregnancy or women of child bearing potential not following an effective method of contraception * Anticipated right sided implantation of the ICD generator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death | Mean follow-up of 3.1 years | The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Complication Rate | 30 days | A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups. |
Countries
Australia, Austria, Canada, Czechia, Finland, France, Germany, Hong Kong, Hungary, Israel, Malaysia, Netherlands, Norway, Poland, Spain, Sweden, Thailand, United Kingdom
Participant flow
Recruitment details
First patient was recruited 13 January 2014, last patient was recruited 4 April 2011. All patients were part of the general ICD population at participating sites.
Participants by arm
| Arm | Count |
|---|---|
| ICD Implant Without Defibrillation Testing Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed. | 1,247 |
| ICD Implant With Defibrillation Testing Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant. | 1,253 |
| Total | 2,500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 17 | 26 |
| Overall Study | Withdrawal by Subject | 24 | 17 |
Baseline characteristics
| Characteristic | ICD Implant Without Defibrillation Testing | ICD Implant With Defibrillation Testing | Total |
|---|---|---|---|
| Age, Continuous | 62.58 years STANDARD_DEVIATION 11.51 | 62.98 years STANDARD_DEVIATION 11.69 | 62.78 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 232 Participants | 244 Participants | 476 Participants |
| Sex: Female, Male Male | 1015 Participants | 1009 Participants | 2024 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 625 / 1,247 | 632 / 1,253 |
| serious Total, serious adverse events | 776 / 1,247 | 790 / 1,253 |
Outcome results
Primary
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death
The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.
Time frame: Mean follow-up of 3.1 years
Population: All patients were analyzed as per intention to treat. An on treatment analysis was performed in 1190 patients in the group without defibrillation testing and in 1165 patients in the group with defibrillation testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Implant Without Defibrillation Testing | First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death | 90 participants |
| ICD Implant With Defibrillation Testing | First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death | 104 participants |
Secondary
Perioperative Complication Rate
A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.
Time frame: 30 days
Population: Perioperative complication rate was assessed in patients undergoing ICD implant. Number of patients having experienced at least one of the predefined complications was assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Implant Without Defibrillation Testing | Perioperative Complication Rate | 69 participants |
| ICD Implant With Defibrillation Testing | Perioperative Complication Rate | 81 participants |