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| Name | Class |
|---|---|
| University of Rochester | OTHER |
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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCEPTA ICD and CRT-D | ICD and CRT-D indicated patients were included in the study. Overall patient population, CRT-D or ICD populations, and patients experiencing or not experiencing a protocol-defined heart failure event were included (dependent on outcomes measured). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCEPTA ICD or CRT-D | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | implant |
| 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. | pre-discharge |
| 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. | 1-month |
| Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude | RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients | implant |
| Clinical Performance at Pre-discharge for RA Sensing Amplitude | RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients | pre-discharge |
| 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 | 1-month |
| Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude | RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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:
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Patients should be selected from the investigator's general population and be indicated for an ICD or CRT-D implantation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Berlin | Berlin | State of Berlin | Germany |
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Recruitment period: Nov2010 - Feb2011
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| ID | Title | Description |
|---|---|---|
| FG000 | INCEPTA ICD and CRT-D | Patients implanted with Incepta ICD or CRT-D device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INCEPTA ICD and CRT-D | Patients implanted with Incepta ICD or CRT-D device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of CRT-D patients with available data at implant | Posted | Mean | Standard Deviation | milli volt (mV) | implant |
|
|
9 months (with a window of plus/minus 1 month)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INCEPTA ICD and CRT-D | Patients implanted with Incepta ICD or CRT-D device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead Dislodgement, Left Ventricle | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extra Cardiac Stimulation, Left Ventricle | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paji Vitoff, Senior Clinical Manager | Guidant, a Boston Scientific Company | 651-582-5415 | paji.vitoff@bsci.com |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| implant |
| 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 | pre-discharge |
| 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 | 1month |
| Clinical Performance at Implant for LV Pacing Threshold | LV pacing threshold results were reported for CRT-D patients at implant. | implant |
| Clinical Performance at Pre-discharge for LV Pacing Threshold | LV pacing threshold results were reported at pre-discharge for CRT-D patients. | pre-discharge |
| Clinical Performance at1-month for LV Pacing Threshold | LV pacing threshold results were reported at 1-month post-implant for CRT-D patients. | 1-month |
| Clinical Performance at Implant for RV Pacing Threshold | RV pacing threshold results were reported at implant | implant |
| Clinical Performance at Pre-discharge for RV Pacing Threshold | RV pacing threshold results were reported at pre-discharge | pre-discharge |
| Clinical Performance at 1-month for RV Pacing Threshold | RV pacing threshold results were reported at 1-month post-implant | 1-month |
| Clinical Performance at Implant for RA Pacing Threshold | RA pacing threshold results were reported for implant | implant |
| Clinical Performance at Pre-discharge for RA Pacing Threshold | RA pacing threshold results were reported at pre-discharge | pre-discharge |
| Clinical Performance at 1-month for RA Pacing Threshold | RA pacing threshold results were reported at 1-month post-implant | 1-month |
| Clinical Performance at Implant LV Pacing Impedance for CRT-D. | LV pacing impedance results at implant were measured in CRT-D. | implant |
| Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D. | LV pacing impedance results were reported for pre-discharge visit | pre-discharge |
| Clinical Performance at 1-month for LV Pacing Impedance for CRT-D. | LV pacing impedance results were reported at 1-month post-implant | 1-month |
| Clinical Performance at Implant for RV Pacing Impedance | RV pacing impedance results were reported at implant | implant |
| Clinical Performance at Pre-discharge for RV Pacing Impedance | RV pacing impedance results were reported for pre-discharge | pre-discharge |
| Clinical Performance at 1-month for RV Pacing Impedance | RV pacing impedance results were reported at 1-month post-implant | 1-month |
| Clinical Performance at Implant for RA Pacing Impedance | RA pacing impedance results were reported at implant | implant |
| Clinical Performance at Pre-discharge for RA Pacing Impedance | RA pacing impedance results were reported at pre-discharge | pre-discharge |
| Clinical Performance at 1-month for RA Pacing Impedance | RA pacing impedance results were reported at 1-month post-implant | 1-month |
| 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. | Overall study results |
| 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. | implant |
| 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. | 1-month |
| 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. | 3-month |
| 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. | implant |
| 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. | 1-month |
| 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. | 3-month |
| 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. | 3-month |
| 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. | Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit |
| Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 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). | 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. | Posted | Median | Inter-Quartile Range | breaths/min | Results were captured from implant time window to the first event for patients with HFE, up to an average of 9 months |
|
|
|
| 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. | 69 patients in the CRT-D arm had available data at pre-discharge visit. | Posted | Mean | Standard Deviation | milli volt (mV) | pre-discharge |
|
|
|
| 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. | 68 patients in the CRT-D cohort had available data at 1month visit | Posted | Mean | Standard Deviation | milli volt (mV) | 1-month |
|
|
|
| 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 | 55 CRT-D patients and 11 ICD patients had available data at implant. | Posted | Mean | Standard Deviation | milli volt (mV) | implant |
|
|
|
| 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 | 55 CRT-D and 11 ICD patients had data available at pre-discharge visit. | Posted | Mean | Standard Deviation | milli volt (mV) | pre-discharge |
|
|
|
| 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 | 53 CRT-D and 11 ICD patients had data available at 1-month visit. | Posted | Mean | Standard Deviation | milli volt (mV) | 1-month |
|
|
|
| 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 | 74 CRT-D and 45 ICD patients had data available at implant | Posted | Mean | Standard Deviation | milli volt (mV) | implant |
|
|
|
| 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 | 73 CRT-D and 44 ICD patients had data available at pre-discharge visit. | Posted | Mean | Standard Deviation | milli volt (mV) | pre-discharge |
|
|
|
| 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 | 68 CRT-D and 43 ICD patients had data available at 1month visit. | Posted | Mean | Standard Deviation | milli volt (mV) | 1month |
|
|
|
| Primary | Clinical Performance at Implant for LV Pacing Threshold | LV pacing threshold results were reported for CRT-D patients at implant. | 78 CRT-D patients had data available at implant. | Posted | Mean | Standard Deviation | volts (V) | implant |
|
|
|
| Primary | Clinical Performance at Pre-discharge for LV Pacing Threshold | LV pacing threshold results were reported at pre-discharge for CRT-D patients. | 75 patients had data available at pre-discharge | Posted | Mean | Standard Deviation | volts (V) | pre-discharge |
|
|
|
| Primary | Clinical Performance at1-month for LV Pacing Threshold | LV pacing threshold results were reported at 1-month post-implant for CRT-D patients. | 73 CRT-D patients had data available at 1-month visit. | Posted | Mean | Standard Deviation | volts (V) | 1-month |
|
|
|
| Primary | Clinical Performance at Implant for RV Pacing Threshold | RV pacing threshold results were reported at implant | 79 CRT-D and 46 ICD patients had data available at implant. | Posted | Mean | Standard Deviation | volts (V) | implant |
|
|
|
| Primary | Clinical Performance at Pre-discharge for RV Pacing Threshold | RV pacing threshold results were reported at pre-discharge | 78 CRT-D and 45 ICD patients had data available at pre-discharge | Posted | Mean | Standard Deviation | volts (V) | pre-discharge |
|
|
|
| Primary | Clinical Performance at 1-month for RV Pacing Threshold | RV pacing threshold results were reported at 1-month post-implant | 75 CRT-D and 43 ICD patients had data available at 1-month visit. | Posted | Mean | Standard Deviation | volts (V) | 1-month |
|
|
|
| Primary | Clinical Performance at Implant for RA Pacing Threshold | RA pacing threshold results were reported for implant | 56 CRT-D and 11 ICD patients had data available at implant | Posted | Mean | Standard Deviation | volts (V) | implant |
|
|
|
| Primary | Clinical Performance at Pre-discharge for RA Pacing Threshold | RA pacing threshold results were reported at pre-discharge | 57 CRT-D and 11 ICD patients had data available at pre-discharge | Posted | Mean | Standard Deviation | volts (V) | pre-discharge |
|
|
|
| Primary | Clinical Performance at 1-month for RA Pacing Threshold | RA pacing threshold results were reported at 1-month post-implant | 54 CRT-D and 11 ICD patients had data available at 1-month visit | Posted | Mean | Standard Deviation | volts (V) | 1-month |
|
|
|
| Primary | Clinical Performance at Implant LV Pacing Impedance for CRT-D. | LV pacing impedance results at implant were measured in CRT-D. | 78 CRT-D patients had data available at implant | Posted | Mean | Standard Deviation | Ohms | implant |
|
|
|
| Primary | Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D. | LV pacing impedance results were reported for pre-discharge visit | 75 CRT-D patients had data available at pre-discharge | Posted | Mean | Standard Deviation | Ohms | pre-discharge |
|
|
|
| Primary | Clinical Performance at 1-month for LV Pacing Impedance for CRT-D. | LV pacing impedance results were reported at 1-month post-implant | 73 CRT-D patients had data available at 1-month visit | Posted | Mean | Standard Deviation | Ohms | 1-month |
|
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| Primary | Clinical Performance at Implant for RV Pacing Impedance | RV pacing impedance results were reported at implant | 79 CRT-D and 46 ICD patients had data available at implant | Posted | Mean | Standard Deviation | Ohms | implant |
|
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|
| Primary | Clinical Performance at Pre-discharge for RV Pacing Impedance | RV pacing impedance results were reported for pre-discharge | 78 CRT-D and 45 ICD patients had data available at pre-discharge | Posted | Mean | Standard Deviation | Ohms | pre-discharge |
|
|
|
| Primary | Clinical Performance at 1-month for RV Pacing Impedance | RV pacing impedance results were reported at 1-month post-implant | 75 CRT-D and 43 ICD patients had data available at 1-month visit | Posted | Mean | Standard Deviation | Ohms | 1-month |
|
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|
| Primary | Clinical Performance at Implant for RA Pacing Impedance | RA pacing impedance results were reported at implant | 56 CRT-D and 11 ICD patients had data available at implant | Posted | Mean | Standard Deviation | Ohms | implant |
|
|
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| Primary | Clinical Performance at Pre-discharge for RA Pacing Impedance | RA pacing impedance results were reported at pre-discharge | 57 CRT-D and 11 ICD patients had data available at pre-discharge | Posted | Mean | Standard Deviation | Ohms | pre-discharge |
|
|
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| Primary | Clinical Performance at 1-month for RA Pacing Impedance | RA pacing impedance results were reported at 1-month post-implant | 54 CRT-D and 11 ICD patients had data available at 1-month | Posted | Mean | Standard Deviation | Ohms | 1-month |
|
|
|
| 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. | All patients from overall study population were considered. Of the total population, the number of product experiences was reported. | Posted | Number | experiences | Overall study results |
|
|
|
| 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. | 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. | Posted | Number | percentage of successful conversions | implant |
|
|
|
| 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. | 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. | Posted | Number | percentage of successful conversions | 1-month |
|
|
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| 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. | 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 % | Posted | Number | percentage of successful conversions | 3-month |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | seconds | implant |
|
|
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| 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. | Of the 1 CRT-D and 1 ICD patients that underwent induced VT/VF at 1month, the mean time for successful conversion was reported. | Posted | Mean | Standard Deviation | seconds | 1-month |
|
|
|
| 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. | 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 | Posted | Mean | Standard Deviation | seconds | 3-month |
|
|
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| 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. | Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported. | Posted | Number | percentage of successful conversions | 3-month | Number of episodes | Participants |
|
|
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| 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. | 118 was the total number of questionnaires completed and available from the PI for analysis. | Posted | Number | issues | Pre-Discharge visit occurred after implant but prior to 1 month follow-up visit |
|
|
|
| 13 |
| 120 |
| 10 |
| 120 |
| Lead Dislodgement, Right Atrium | Cardiac disorders | Systematic Assessment |
|
| Lead Dislodgement, Right Ventricle | Cardiac disorders | Systematic Assessment |
|
| Elevated Threshold, Right Atrium | Cardiac disorders | Systematic Assessment |
|
| Elevated Threshold, Right Ventricle | Cardiac disorders | Systematic Assessment |
|
| Insulation Breach, Right Atrium | Cardiac disorders | Systematic Assessment |
|
| Inadvertent Ventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Unable to Convert, Defibrillation Lead | Cardiac disorders | Systematic Assessment |
|
| Infection, Post-Surgical | Surgical and medical procedures | Systematic Assessment |
|
Sponsor shall be provided with copy of all Trial-related manuscripts and reports for review and comment
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |