Heart Failure, Sudden Cardiac Death
Conditions
Brief summary
This study has 2 purposes: The first purpose of the study is to test a new family of Boston Scientific Implantable Cardioverter Defibrillators (ICDs) and cardiac resynchronization therapy ICDs (CRT-Ds) and show how well these new devices work in patients. This new family is called the INCEPTA ICD and the INCEPTA CRT-D. The second purpose of the study is to collect data from a feature that monitors breathing. It is called the Respiratory Rate Trend (RRT). These data will help to better understand how changes in breathing relate to changes in clinical conditions.
Detailed description
Study Purpose Study purpose I: To evaluate and document appropriate clinical performance of the INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system and the INCEPTA cardiac resynchronization therapy ICD (CRT-D) system and associated application software. Study purpose II: Demonstrate the clinical relevance of chronic ambulatory daily median Respiratory Rate Trend (RRT) in HF patients Study Device * INCEPTA (DR and VR) implantable cardioverter defibrillator (ICD) system (Models F160, F161, F162, F163) * INCEPTA cardiac resynchronization therapy ICD (CRT-D) system (Models P162, P163, P165) Indication ICD / CRT-D Indication according to standard clinical practice Study Objectives The study has two primary objectives, linked to the respective study purposes: For purpose I: The objective is to collect data on the clinical performance of the INCEPTA ICD and CRT-D devices during standard clinical use at implant, pre-discharge and at a 1-month post-implant. Clinical performance included analysis of pacing thresholds, pacing impedance, sensing thresholds, number of successfully converted VT/VF episodes, induced episodes detection times, spontaneous episodes, wanded telemetry, adverse events (AEs) and product experiences. For purpose II: The objective is to show that daily median respiratory rate increases more in patients who experience an HF-event (Group 1) than in patients who do not experience an HF-event (Group 2). This is a prospective, multi-centre, field following study. Up to 35 study centers in the International geography will enrol 120 patients.
Interventions
DEVICEINCEPTA ICD or CRT-D
Sponsors
University of Rochester
Guidant Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical study; * Patients whose age is 18 or above, or of legal age to give informed consent specific to national law * Patients indicated for an ICD according to normal clinical practice (for those patients receiving an INCEPTA ICD). -As soon as 20 ICD patients are included in the study for purpose I, only NYHA Class III patients will be allowed in the study. * New York Heart Association (NYHA) Class III patients indicated for a CRT-D according to normal clinical practice (for those patients receiving an INCEPTA CRT-D).
Exclusion criteria
* Women of childbearing potential who are or might be pregnant at the time of the study (method of assessment upon physician's discretion) * Enrolled in any other concurrent study. * Inability or refusal to comply with the follow-up schedule * Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days * Patients prescribed to positive airway pressure therapy * A life expectancy of less than 1 year, per physician discretion * Patient in NYHA Class IV during the last 4 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wanded Telemetry Issues at Pre-discharge Follow-up | Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit | The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort. |
| Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients | implant | Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients. |
| Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients | pre-discharge | Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients. |
| Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients | 1-month | LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients. |
| Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude | implant | RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients |
| Clinical Performance at Pre-discharge for RA Sensing Amplitude | pre-discharge | RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients |
| Clinical Performance at1-month for RA Sensing Amplitude | 1-month | RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients |
| Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude | implant | RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients |
| Spontaneous Episode Conversion Success Rate at 3 Months | 3-month | Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined. |
| Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude | pre-discharge | RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients |
| Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude | 1month | RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients |
| Clinical Performance at Implant for LV Pacing Threshold | implant | LV pacing threshold results were reported for CRT-D patients at implant. |
| Clinical Performance at Pre-discharge for LV Pacing Threshold | pre-discharge | LV pacing threshold results were reported at pre-discharge for CRT-D patients. |
| Clinical Performance at1-month for LV Pacing Threshold | 1-month | LV pacing threshold results were reported at 1-month post-implant for CRT-D patients. |
| Clinical Performance at Implant for RV Pacing Threshold | implant | RV pacing threshold results were reported at implant |
| Clinical Performance at Pre-discharge for RV Pacing Threshold | pre-discharge | RV pacing threshold results were reported at pre-discharge |
| Clinical Performance at 1-month for RV Pacing Threshold | 1-month | RV pacing threshold results were reported at 1-month post-implant |
| Clinical Performance at Implant for RA Pacing Threshold | implant | RA pacing threshold results were reported for implant |
| Clinical Performance at Pre-discharge for RA Pacing Threshold | pre-discharge | RA pacing threshold results were reported at pre-discharge |
| Clinical Performance at 1-month for RA Pacing Threshold | 1-month | RA pacing threshold results were reported at 1-month post-implant |
| Clinical Performance at Implant LV Pacing Impedance for CRT-D. | implant | LV pacing impedance results at implant were measured in CRT-D. |
| Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D. | pre-discharge | LV pacing impedance results were reported for pre-discharge visit |
| Clinical Performance at 1-month for LV Pacing Impedance for CRT-D. | 1-month | LV pacing impedance results were reported at 1-month post-implant |
| Clinical Performance at Implant for RV Pacing Impedance | implant | RV pacing impedance results were reported at implant |
| Clinical Performance at Pre-discharge for RV Pacing Impedance | pre-discharge | RV pacing impedance results were reported for pre-discharge |
| Clinical Performance at 1-month for RV Pacing Impedance | 1-month | RV pacing impedance results were reported at 1-month post-implant |
| Clinical Performance at Implant for RA Pacing Impedance | implant | RA pacing impedance results were reported at implant |
| Clinical Performance at Pre-discharge for RA Pacing Impedance | pre-discharge | RA pacing impedance results were reported at pre-discharge |
| Clinical Performance at 1-month for RA Pacing Impedance | 1-month | RA pacing impedance results were reported at 1-month post-implant |
| Product Experiences Reported by the Site for All Patients for Study Duration | Overall study results | Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback. |
| Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant | implant | The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted. |
| Induced VT/VF Episode Successful Conversion Rates at 1-month | 1-month | The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted. |
| Induced VT/VF Episode Successful Conversion Rates at 3-months | 3-month | The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted. |
| Induced Episode Detection Times at Implant | implant | The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF. |
| Induced Episode Detection Times at 1-month | 1-month | The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF. |
| Induced Episode Detection Times at 3 Months | 3-month | The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event. | Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months | A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2). |
Countries
Germany
Participant flow
Recruitment details
Recruitment period: Nov2010 - Feb2011
Participants by arm
| Arm | Count |
|---|---|
| INCEPTA ICD and CRT-D Patients implanted with Incepta ICD or CRT-D device | 120 |
| Total | 120 |
Baseline characteristics
| Characteristic | INCEPTA ICD and CRT-D |
|---|---|
| Age, Customized CRT-D | 67.4 years STANDARD_DEVIATION 10.1 |
| Age, Customized ICD | 62.7 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 120 |
| serious Total, serious adverse events | 13 / 120 |
Outcome results
Primary
Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients
LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.
Time frame: 1-month
Population: 68 patients in the CRT-D cohort had available data at 1month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients | 17.2 milli volt (mV) | Standard Deviation 7.1 |
Primary
Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.
LV pacing impedance results were reported at 1-month post-implant
Time frame: 1-month
Population: 73 CRT-D patients had data available at 1-month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at 1-month for LV Pacing Impedance for CRT-D. | 778 Ohms | Standard Deviation 265 |
Primary
Clinical Performance at1-month for LV Pacing Threshold
LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.
Time frame: 1-month
Population: 73 CRT-D patients had data available at 1-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at1-month for LV Pacing Threshold | 1.3 volts (V) | Standard Deviation 0.9 |
Primary
Clinical Performance at 1-month for RA Pacing Impedance
RA pacing impedance results were reported at 1-month post-implant
Time frame: 1-month
Population: 54 CRT-D and 11 ICD patients had data available at 1-month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at 1-month for RA Pacing Impedance | 534 Ohms | Standard Deviation 152 |
| Group 2: Patients Without a HFE | Clinical Performance at 1-month for RA Pacing Impedance | 655 Ohms | Standard Deviation 447 |
Primary
Clinical Performance at 1-month for RA Pacing Threshold
RA pacing threshold results were reported at 1-month post-implant
Time frame: 1-month
Population: 54 CRT-D and 11 ICD patients had data available at 1-month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at 1-month for RA Pacing Threshold | 1.0 volts (V) | Standard Deviation 1 |
| Group 2: Patients Without a HFE | Clinical Performance at 1-month for RA Pacing Threshold | 1.0 volts (V) | Standard Deviation 0.7 |
Primary
Clinical Performance at1-month for RA Sensing Amplitude
RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Time frame: 1-month
Population: 53 CRT-D and 11 ICD patients had data available at 1-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at1-month for RA Sensing Amplitude | 4.9 milli volt (mV) | Standard Deviation 2.9 |
| Group 2: Patients Without a HFE | Clinical Performance at1-month for RA Sensing Amplitude | 3.7 milli volt (mV) | Standard Deviation 2.7 |
Primary
Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude
RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients
Time frame: 1month
Population: 68 CRT-D and 43 ICD patients had data available at 1month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude | 17.9 milli volt (mV) | Standard Deviation 6.2 |
| Group 2: Patients Without a HFE | Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude | 17.1 milli volt (mV) | Standard Deviation 16.6 |
Primary
Clinical Performance at 1-month for RV Pacing Impedance
RV pacing impedance results were reported at 1-month post-implant
Time frame: 1-month
Population: 75 CRT-D and 43 ICD patients had data available at 1-month visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at 1-month for RV Pacing Impedance | 590 Ohms | Standard Deviation 209 |
| Group 2: Patients Without a HFE | Clinical Performance at 1-month for RV Pacing Impedance | 658 Ohms | Standard Deviation 295 |
Primary
Clinical Performance at 1-month for RV Pacing Threshold
RV pacing threshold results were reported at 1-month post-implant
Time frame: 1-month
Population: 75 CRT-D and 43 ICD patients had data available at 1-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at 1-month for RV Pacing Threshold | 0.9 volts (V) | Standard Deviation 0.5 |
| Group 2: Patients Without a HFE | Clinical Performance at 1-month for RV Pacing Threshold | 1.4 volts (V) | Standard Deviation 1.7 |
Primary
Clinical Performance at Implant for LV Pacing Threshold
LV pacing threshold results were reported for CRT-D patients at implant.
Time frame: implant
Population: 78 CRT-D patients had data available at implant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for LV Pacing Threshold | 1.3 volts (V) | Standard Deviation 0.8 |
Primary
Clinical Performance at Implant for RA Pacing Impedance
RA pacing impedance results were reported at implant
Time frame: implant
Population: 56 CRT-D and 11 ICD patients had data available at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for RA Pacing Impedance | 538 Ohms | Standard Deviation 132 |
| Group 2: Patients Without a HFE | Clinical Performance at Implant for RA Pacing Impedance | 670 Ohms | Standard Deviation 443 |
Primary
Clinical Performance at Implant for RA Pacing Threshold
RA pacing threshold results were reported for implant
Time frame: implant
Population: 56 CRT-D and 11 ICD patients had data available at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for RA Pacing Threshold | 0.8 volts (V) | Standard Deviation 0.7 |
| Group 2: Patients Without a HFE | Clinical Performance at Implant for RA Pacing Threshold | 1.0 volts (V) | Standard Deviation 0.7 |
Primary
Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude
RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients
Time frame: implant
Population: 55 CRT-D patients and 11 ICD patients had available data at implant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude | 3.8 milli volt (mV) | Standard Deviation 2 |
| Group 2: Patients Without a HFE | Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude | 3.2 milli volt (mV) | Standard Deviation 2.2 |
Primary
Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude
RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients
Time frame: implant
Population: 74 CRT-D and 45 ICD patients had data available at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude | 16.2 milli volt (mV) | Standard Deviation 6.6 |
| Group 2: Patients Without a HFE | Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude | 15.8 milli volt (mV) | Standard Deviation 5.8 |
Primary
Clinical Performance at Implant for RV Pacing Impedance
RV pacing impedance results were reported at implant
Time frame: implant
Population: 79 CRT-D and 46 ICD patients had data available at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for RV Pacing Impedance | 637 Ohms | Standard Deviation 208 |
| Group 2: Patients Without a HFE | Clinical Performance at Implant for RV Pacing Impedance | 807 Ohms | Standard Deviation 385 |
Primary
Clinical Performance at Implant for RV Pacing Threshold
RV pacing threshold results were reported at implant
Time frame: implant
Population: 79 CRT-D and 46 ICD patients had data available at implant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant for RV Pacing Threshold | 0.7 volts (V) | Standard Deviation 0.3 |
| Group 2: Patients Without a HFE | Clinical Performance at Implant for RV Pacing Threshold | 0.8 volts (V) | Standard Deviation 0.5 |
Primary
Clinical Performance at Implant LV Pacing Impedance for CRT-D.
LV pacing impedance results at implant were measured in CRT-D.
Time frame: implant
Population: 78 CRT-D patients had data available at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Implant LV Pacing Impedance for CRT-D. | 879 Ohms | Standard Deviation 296 |
Primary
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.
LV pacing impedance results were reported for pre-discharge visit
Time frame: pre-discharge
Population: 75 CRT-D patients had data available at pre-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D. | 777 Ohms | Standard Deviation 244 |
Primary
Clinical Performance at Pre-discharge for LV Pacing Threshold
LV pacing threshold results were reported at pre-discharge for CRT-D patients.
Time frame: pre-discharge
Population: 75 patients had data available at pre-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for LV Pacing Threshold | 1.5 volts (V) | Standard Deviation 1.2 |
Primary
Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients
Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.
Time frame: pre-discharge
Population: 69 patients in the CRT-D arm had available data at pre-discharge visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients | 14.9 milli volt (mV) | Standard Deviation 7.7 |
Primary
Clinical Performance at Pre-discharge for RA Pacing Impedance
RA pacing impedance results were reported at pre-discharge
Time frame: pre-discharge
Population: 57 CRT-D and 11 ICD patients had data available at pre-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for RA Pacing Impedance | 512 Ohms | Standard Deviation 141 |
| Group 2: Patients Without a HFE | Clinical Performance at Pre-discharge for RA Pacing Impedance | 656 Ohms | Standard Deviation 448 |
Primary
Clinical Performance at Pre-discharge for RA Pacing Threshold
RA pacing threshold results were reported at pre-discharge
Time frame: pre-discharge
Population: 57 CRT-D and 11 ICD patients had data available at pre-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for RA Pacing Threshold | 0.8 volts (V) | Standard Deviation 0.9 |
| Group 2: Patients Without a HFE | Clinical Performance at Pre-discharge for RA Pacing Threshold | 0.9 volts (V) | Standard Deviation 0.8 |
Primary
Clinical Performance at Pre-discharge for RA Sensing Amplitude
RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Time frame: pre-discharge
Population: 55 CRT-D and 11 ICD patients had data available at pre-discharge visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for RA Sensing Amplitude | 4.1 milli volt (mV) | Standard Deviation 2 |
| Group 2: Patients Without a HFE | Clinical Performance at Pre-discharge for RA Sensing Amplitude | 3.9 milli volt (mV) | Standard Deviation 2.6 |
Primary
Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude
RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients
Time frame: pre-discharge
Population: 73 CRT-D and 44 ICD patients had data available at pre-discharge visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude | 16.7 milli volt (mV) | Standard Deviation 6.1 |
| Group 2: Patients Without a HFE | Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude | 16.9 milli volt (mV) | Standard Deviation 5.9 |
Primary
Clinical Performance at Pre-discharge for RV Pacing Impedance
RV pacing impedance results were reported for pre-discharge
Time frame: pre-discharge
Population: 78 CRT-D and 45 ICD patients had data available at pre-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for RV Pacing Impedance | 604 Ohms | Standard Deviation 196 |
| Group 2: Patients Without a HFE | Clinical Performance at Pre-discharge for RV Pacing Impedance | 686 Ohms | Standard Deviation 284 |
Primary
Clinical Performance at Pre-discharge for RV Pacing Threshold
RV pacing threshold results were reported at pre-discharge
Time frame: pre-discharge
Population: 78 CRT-D and 45 ICD patients had data available at pre-discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance at Pre-discharge for RV Pacing Threshold | 0.7 volts (V) | Standard Deviation 0.3 |
| Group 2: Patients Without a HFE | Clinical Performance at Pre-discharge for RV Pacing Threshold | 0.8 volts (V) | Standard Deviation 1.1 |
Primary
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients
Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.
Time frame: implant
Population: The number of CRT-D patients with available data at implant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients | 14.4 milli volt (mV) | Standard Deviation 7.3 |
Primary
Induced Episode Detection Times at 1-month
The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.
Time frame: 1-month
Population: Of the 1 CRT-D and 1 ICD patients that underwent induced VT/VF at 1month, the mean time for successful conversion was reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Induced Episode Detection Times at 1-month | 2.06 seconds | Standard Deviation 0 |
| Group 2: Patients Without a HFE | Induced Episode Detection Times at 1-month | 2.06 seconds | Standard Deviation 0 |
Primary
Induced Episode Detection Times at 3 Months
The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.
Time frame: 3-month
Population: Of the 6 CRT-D and 3 ICD patients with available data that had succesful conversion after induced VT/VF episodes, the mean time was determined at 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Induced Episode Detection Times at 3 Months | 2.28 seconds | Standard Deviation 0.28 |
| Group 2: Patients Without a HFE | Induced Episode Detection Times at 3 Months | 2.29 seconds | Standard Deviation 0.06 |
Primary
Induced Episode Detection Times at Implant
The mean time it took to complete a successful conversion after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. The time was recorded (in seconds) for the time duration that was required to successfully convert the patient after inducing VT/VF.
Time frame: implant
Population: Of the 30 CRT-D and 22 ICD patients with induced VT/VF episodes, the mean time required for conversion was reported for all available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Induced Episode Detection Times at Implant | 2.46 seconds | Standard Deviation 0.38 |
| Group 2: Patients Without a HFE | Induced Episode Detection Times at Implant | 2.40 seconds | Standard Deviation 0.42 |
Primary
Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant
The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.
Time frame: implant
Population: Of the 30 CRT-D and 22 ICD patients with induced episodes, the number with successful conversions was determined. The % of patients that had successful conversion was then reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCEPTA CRT-D Patients | Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant | 100 percentage of successful conversions |
| Group 2: Patients Without a HFE | Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant | 100 percentage of successful conversions |
Primary
Induced VT/VF Episode Successful Conversion Rates at 1-month
The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.
Time frame: 1-month
Population: Of all patients that experienced an induced VT/VF episode at 1-month, the number that had successful conversions was reported for both CRT-D and ICD patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCEPTA CRT-D Patients | Induced VT/VF Episode Successful Conversion Rates at 1-month | 100 percentage of successful conversions |
| Group 2: Patients Without a HFE | Induced VT/VF Episode Successful Conversion Rates at 1-month | 100 percentage of successful conversions |
Primary
Induced VT/VF Episode Successful Conversion Rates at 3-months
The % of successful conversions after inducing a VT/VF episode was analyzed for available data from CRT and ICD group patients. All episodes of induced VT/VF that resolved with successful conversion were counted from the total attempted conversions and reported as the % of successful conversions from those attempted.
Time frame: 3-month
Population: Of the 6 CRTD and 3 ICD patients that had induced VT/VF episodes at 3-month follow-up, the number of those that were converted successfully was reported in %
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCEPTA CRT-D Patients | Induced VT/VF Episode Successful Conversion Rates at 3-months | 100 percentage of successful conversions |
| Group 2: Patients Without a HFE | Induced VT/VF Episode Successful Conversion Rates at 3-months | 100 percentage of successful conversions |
Primary
Product Experiences Reported by the Site for All Patients for Study Duration
Product experiences reported may include the shock impedance noise display, problems encountered with the universal serial bus (USB), a program parameter mismatch, reverse mode switches, electrogram (EGM) noise without oversensing, lead connection issues, or customer device feedback.
Time frame: Overall study results
Population: All patients from overall study population were considered. Of the total population, the number of product experiences was reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCEPTA CRT-D Patients | Product Experiences Reported by the Site for All Patients for Study Duration | 65 experiences |
Primary
Spontaneous Episode Conversion Success Rate at 3 Months
Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.
Time frame: 3-month
Population: Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCEPTA CRT-D Patients | Spontaneous Episode Conversion Success Rate at 3 Months | 100 percentage of successful conversions |
| Group 2: Patients Without a HFE | Spontaneous Episode Conversion Success Rate at 3 Months | 100 percentage of successful conversions |
Primary
Wanded Telemetry Issues at Pre-discharge Follow-up
The Investigators completed a questionnaire based on the performance of the wanded telemetry during device interrogations at pre-discharge follow-up. The number of problems reported were counted from the entire study cohort.
Time frame: Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit
Population: 118 was the total number of questionnaires completed and available from the PI for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INCEPTA CRT-D Patients | Wanded Telemetry Issues at Pre-discharge Follow-up | 1 issues |
Secondary
Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event.
A comparison of the change in respiratory rate trend over time was made between patients who experienced a protocol-defined HF event (HFE) (Group1: Patients with a HFE) and patients who did not experience a protocol-defined heart failure event (Group 2: Patients without a HFE). Only patients with at least 3 valid daily respiratory rate values (60%) out of each 5-day window were evaluated. The objective was to show that daily median respiratory rate increases more in patients who experience a HFE (Group 1) than in patients who do not experience an HFE (Group 2). A comparison between patients who experience a HFE (Group 1) and patients who do not experience a HFE (Group 2). Two average daily median respiratory rates were done per patient: 60 to 56 days before an index time and 11 to 7 days before the same index time; the difference between these two averaged daily median respiratory rates was done. Index time=day of the first HFE (Group 1) and day of 6-month visit (Group 2).
Time frame: Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months
Population: HF events were reported and adjudicated to classify patients into group 1 or 2. Group 1=17 HFEs in 13 patients. For patients with multiple HFEs,only the first with sufficient data was used. 8/13 with a HFE had data for the endpoint analysis.Group 2=95 patients with 9 month follow-up. 90/95 had data eligible for inclusion in the endpoint analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| INCEPTA CRT-D Patients | Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event. | -0.30 breaths/min | — |
| Group 2: Patients Without a HFE | Evaluate the Daily Median Respiratory Rate Trend in Patients Who Experience a HF-event Compared to Patients Who do Not Experience a HF-event. | 0 breaths/min | Inter-Quartile Range 1.06 |