Patients With an Indication for an ICD Implantation According to the Guidelines
Conditions
Brief summary
ProSA is a prospective, non-randomized, multicenter, observational study investigating the utilization and effectiveness of the Smart Shock™ algorithm in ICD patients treated with a Protecta™, Protecta™ XT or any equivalent following product.
Interventions
None listed
Sponsors
Medtronic GmbH Germany
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients implanted with an Implantable Cardioverter Defibrillator (ICD) with the smart shock algorithm (Protecta™, Protecta™ XT or any equivalent following product) * written informed consent
Exclusion criteria
* patients with life expectancy less than 24 months * patients younger than 18 years * pregnant or breast feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. | 24 months | Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients. Endpoints for the primary objective: * Episodes with shock therapy * Episodes without shock delivery due to Smart Shock™ technology * Episodes classified as supraventricular tachycardia (SVT) by PR Logic * Episodes classified as SVT by Wavelet * Shock therapy suppressed by T-wave Discrimination * Shock therapy suppressed by Lead Noise Discrimination * Shock therapy suppressed by Confirmation + * Episode with successful anti-tachycardia pacing (ATP) During Charging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology | 24 months | Endpoint: Patients without shock delivery due to Smart Shock technology |
| Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes. | 24 months | Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD |
| Number of Patients With All Smart Shock Algorithms Are Programmed on | 90 days or 180 days | Endpoint: Patients, in which none of the Smart Shock algorithms is programmed OFF during the first Follow-Up after a maximum length of 90 days and 180 days. |
| Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming. | At the first Follow-Up ≥ 90 days post-implant | Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant. Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices: * Lead Noise Discrimination = 'OnWithTimeout' * Lead Failure Predictor = 'On' * PR-Logic: AfibAflutter Rejection Rule = 'On' * PR-Logic: Sinus Tach Rejection Rule = 'On' * PR-Logic: Other 1:1 Rejection Rule = 'On' * High Rate Timeout = 'Off' * VF High Rate Timeout = 'Off' * Wavelet Rejection Rule = 'On' * VF Detection Interval = 320 and SVT Minimum Cycle Length = 260 * T-Wave Oversensing Discrimination = 'On' * ATP During Charging = 'DuringCharging' Nominals for single chamber ICDs: * Lead Noise Discrimination = 'OnWithTimeout' * Lead Failure Predictor = 'On' * High Rate Timeout = 'Off' * VF High Rate Timeout = '0.75 min' * Wavelet Rejection Rule = 'On' * VF Detection Interval = 320 and SVT Minimum Cycle Length = 260 * T-Wave Oversensing D |
| Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms | through study completion | Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'. |
| Number of Patients That Developed AT/AF | 24 months | Endpoint: patients with \>5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass) |
Participant flow
Recruitment details
504 patients were enrolled at 29 German sites between 09-Jun-2010 and 22-Oct-2012
Participants by arm
| Arm | Count |
|---|---|
| ICD Patients Patients with an indication for an ICD implantation according to the guidelines treated with a Protecta™, Protecta™ XT or any equivalent following product | 504 |
| Total | 504 |
Baseline characteristics
| Characteristic | ICD Patients |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 12.4 |
| Region of Enrollment Germany | 504 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology.
Smart Shock technology is a suite of algorithms that are designed to prevent inappropriate shocks in ICD&CRT patients. Endpoints for the primary objective: * Episodes with shock therapy * Episodes without shock delivery due to Smart Shock™ technology * Episodes classified as supraventricular tachycardia (SVT) by PR Logic * Episodes classified as SVT by Wavelet * Shock therapy suppressed by T-wave Discrimination * Shock therapy suppressed by Lead Noise Discrimination * Shock therapy suppressed by Confirmation + * Episode with successful anti-tachycardia pacing (ATP) During Charging
Time frame: 24 months
Population: The change of episodes of episodes inappropriately treated by shock due to Smart Shock™ was calculated as follow:~change of episodes= (Episodes without shock therapy due to Smart Shock™)/(total number of episodes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Patients (Single Arm Study) | Analysis of Change of Episodes Inappropriately Treated by Shock Therapy Due to Smart Shock™ Technology. | 94.9 % of episodes wo shock due to SmartShock |
Secondary
Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes.
Endpoint: Number of primary prevention patients with at least one ventricular fibrillation (VF) episode detected and successfully treated by the ICD
Time frame: 24 months
Population: Of all 272 patients with primary preventive indication, only 265 patients had device data available for the Follow-Up period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICD Patients (Single Arm Study) | Analysis of the Number of Patients With Primary Preventive Indication for an ICD That Develop VF Episodes. | 15 Participants |
Secondary
Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms
Endpoint: Episode classified by the device as T-wave Oversensing or 'Noise'.
Time frame: through study completion
Population: In total, 71 episodes were detected by the device and classified as T-wave Oversensing or Noise, but only 20 had electrogram (EGM) strips available. The analysis of the positive predictive value (PPV) was performed on these 20 episodes only. The number of true positives was 20. The number of false positives was 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Patients (Single Arm Study) | Analysis of the Positive Predictive Value of the Investigated ICD Oversensing Algorithms | 100 Positive Predictive Value in % |
Secondary
Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming.
Endpoint: Deviation of ICD parameter programming in comparison to nominal programming at the first Follow-Up ≥ 90 days post-implant. Nominals for dual chamber ICD or cardiac resynchronization therapy (CRT) devices: * Lead Noise Discrimination = 'OnWithTimeout' * Lead Failure Predictor = 'On' * PR-Logic: AfibAflutter Rejection Rule = 'On' * PR-Logic: Sinus Tach Rejection Rule = 'On' * PR-Logic: Other 1:1 Rejection Rule = 'On' * High Rate Timeout = 'Off' * VF High Rate Timeout = 'Off' * Wavelet Rejection Rule = 'On' * VF Detection Interval = 320 and SVT Minimum Cycle Length = 260 * T-Wave Oversensing Discrimination = 'On' * ATP During Charging = 'DuringCharging' Nominals for single chamber ICDs: * Lead Noise Discrimination = 'OnWithTimeout' * Lead Failure Predictor = 'On' * High Rate Timeout = 'Off' * VF High Rate Timeout = '0.75 min' * Wavelet Rejection Rule = 'On' * VF Detection Interval = 320 and SVT Minimum Cycle Length = 260 * T-Wave Oversensing D
Time frame: At the first Follow-Up ≥ 90 days post-implant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICD Patients (Single Arm Study) | Analysis of the Proportion of Patients in Which ICD Parameters Remain on Nominal Programming. | 421 Participants |
Secondary
Number of Patients That Developed AT/AF
Endpoint: patients with \>5 min atrial tachycardia/atrial fibrillation (AT/AF) in 'Daily Log' (Cardiac Compass)
Time frame: 24 months
Population: Out of all patients analyzed (N=504), the patients with Single-Chamber-ICDs were excluded as these devices had no feature to identify AT/AF. This lead to N=367. Out of these 367 patients only 337 had Follow-Up data available whereas 30 patients only had implant data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICD Patients (Single Arm Study) | Number of Patients That Developed AT/AF | 117 Participants |
Secondary
Number of Patients With All Smart Shock Algorithms Are Programmed on
Endpoint: Patients, in which none of the Smart Shock algorithms is programmed OFF during the first Follow-Up after a maximum length of 90 days and 180 days.
Time frame: 90 days or 180 days
Population: Patients with data available at 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ICD Patients (Single Arm Study) | Number of Patients With All Smart Shock Algorithms Are Programmed on | 300 Participants |
Secondary
Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology
Endpoint: Patients without shock delivery due to Smart Shock technology
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICD Patients (Single Arm Study) | Percentage of Patients, Without Shock Delivery Due to Smart Shock Technology | 15.3 pat. w. at least 1 shock prevented in % |