Trial Outcomes & Findings for Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study (NCT NCT01227785)

NCT ID: NCT01227785

Last Updated: 2014-04-25

Results Overview

RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients

• Recruitment status: COMPLETED
• Target enrollment: 120 participants
• Primary outcome timeframe: pre-discharge
• Results posted on: 2014-04-25

Participant Flow

Recruitment period: Nov2010 - Feb2011

Participant milestones

Measure	INCEPTA ICD and CRT-D Patients implanted with Incepta ICD or CRT-D device
Overall Study STARTED	120
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Next Generation INCEPTA Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT-D) Field Following Study

Baseline characteristics by cohort

Measure	INCEPTA ICD and CRT-D n=120 Participants Patients implanted with Incepta ICD or CRT-D device
Age, Customized ICD	62.7 years STANDARD_DEVIATION 10.6 • n=5 Participants
Age, Customized CRT-D	67.4 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants

PRIMARY outcome

Timeframe: implant

Population: The number of CRT-D patients with available data at implant

Left Ventricular (LV) Sensed Amplitude results were reported at implant for CRT-D patients.

Outcome measures

Measure	INCEPTA CRT-D Patients n=74 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance for Left Ventricular (LV) Sensing Amplitude at Implant for CRT-D Patients	14.4 milli volt (mV) Standard Deviation 7.3	—

PRIMARY outcome

Timeframe: pre-discharge

Population: 69 patients in the CRT-D arm had available data at pre-discharge visit.

Left Ventricular (LV) Sensed Amplitude results were reported pre-discharge for CRT-D patients.

Outcome measures

Measure	INCEPTA CRT-D Patients n=69 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for LV Sensing Amplitude for CRT-D Patients	14.9 milli volt (mV) Standard Deviation 7.7	—

PRIMARY outcome

Timeframe: 1-month

Population: 68 patients in the CRT-D cohort had available data at 1month visit

LV Sensed Amplitude results were reported at 1-month post-implant for CRT-D patients.

Outcome measures

Measure	INCEPTA CRT-D Patients n=68 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at1-month for Left Ventricular (LV) Sensing Amplitude for CRT-D Patients	17.2 milli volt (mV) Standard Deviation 7.1	—

PRIMARY outcome

Timeframe: implant

Population: 55 CRT-D patients and 11 ICD patients had available data at implant.

RA Sensed Amplitude results were reported for implant for CRT-D and ICD patients

Outcome measures

Measure	INCEPTA CRT-D Patients n=55 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for Right Atrium (RA) Sensing Amplitude	3.8 milli volt (mV) Standard Deviation 2.0	3.2 milli volt (mV) Standard Deviation 2.2

PRIMARY outcome

Timeframe: pre-discharge

Population: 55 CRT-D and 11 ICD patients had data available at pre-discharge visit.

RA Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients

Outcome measures

Measure	INCEPTA CRT-D Patients n=55 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for RA Sensing Amplitude	4.1 milli volt (mV) Standard Deviation 2.0	3.9 milli volt (mV) Standard Deviation 2.6

PRIMARY outcome

Timeframe: 1-month

Population: 53 CRT-D and 11 ICD patients had data available at 1-month visit.

RA Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients

Outcome measures

Measure	INCEPTA CRT-D Patients n=53 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at1-month for RA Sensing Amplitude	4.9 milli volt (mV) Standard Deviation 2.9	3.7 milli volt (mV) Standard Deviation 2.7

PRIMARY outcome

Timeframe: implant

Population: 74 CRT-D and 45 ICD patients had data available at implant

RV Sensed Amplitude results were reported at implant for CRT-D and ICD patients

Outcome measures

Measure	INCEPTA CRT-D Patients n=74 Participants	Group 2: Patients Without a HFE n=45 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for Right Ventricle (RV) Sensing Amplitude	16.2 milli volt (mV) Standard Deviation 6.6	15.8 milli volt (mV) Standard Deviation 5.8

PRIMARY outcome

Timeframe: pre-discharge

Population: 73 CRT-D and 44 ICD patients had data available at pre-discharge visit.

RV Sensed Amplitude results were reported at pre-discharge for CRT-D and ICD patients

Outcome measures

Measure	INCEPTA CRT-D Patients n=73 Participants	Group 2: Patients Without a HFE n=44 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for Right Ventricle (RV) Sensing Amplitude	16.7 milli volt (mV) Standard Deviation 6.1	16.9 milli volt (mV) Standard Deviation 5.9

PRIMARY outcome

Timeframe: 1month

Population: 68 CRT-D and 43 ICD patients had data available at 1month visit.

RV Sensed Amplitude results were reported at 1-month post-implant for CRT-D and ICD patients

Outcome measures

Measure	INCEPTA CRT-D Patients n=68 Participants	Group 2: Patients Without a HFE n=43 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at1-month for Right Ventricle (RV) Sensing Amplitude	17.9 milli volt (mV) Standard Deviation 6.2	17.1 milli volt (mV) Standard Deviation 16.6

PRIMARY outcome

Timeframe: implant

Population: 78 CRT-D patients had data available at implant.

LV pacing threshold results were reported for CRT-D patients at implant.

Outcome measures

Measure	INCEPTA CRT-D Patients n=78 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for LV Pacing Threshold	1.3 volts (V) Standard Deviation 0.8	—

PRIMARY outcome

Timeframe: pre-discharge

Population: 75 patients had data available at pre-discharge

LV pacing threshold results were reported at pre-discharge for CRT-D patients.

Outcome measures

Measure	INCEPTA CRT-D Patients n=75 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for LV Pacing Threshold	1.5 volts (V) Standard Deviation 1.2	—

PRIMARY outcome

Timeframe: 1-month

Population: 73 CRT-D patients had data available at 1-month visit.

LV pacing threshold results were reported at 1-month post-implant for CRT-D patients.

Outcome measures

Measure	INCEPTA CRT-D Patients n=73 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at1-month for LV Pacing Threshold	1.3 volts (V) Standard Deviation 0.9	—

PRIMARY outcome

Timeframe: implant

Population: 79 CRT-D and 46 ICD patients had data available at implant.

RV pacing threshold results were reported at implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=79 Participants	Group 2: Patients Without a HFE n=46 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for RV Pacing Threshold	0.7 volts (V) Standard Deviation 0.3	0.8 volts (V) Standard Deviation 0.5

PRIMARY outcome

Timeframe: pre-discharge

Population: 78 CRT-D and 45 ICD patients had data available at pre-discharge

RV pacing threshold results were reported at pre-discharge

Outcome measures

Measure	INCEPTA CRT-D Patients n=78 Participants	Group 2: Patients Without a HFE n=45 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for RV Pacing Threshold	0.7 volts (V) Standard Deviation 0.3	0.8 volts (V) Standard Deviation 1.1

PRIMARY outcome

Timeframe: 1-month

Population: 75 CRT-D and 43 ICD patients had data available at 1-month visit.

RV pacing threshold results were reported at 1-month post-implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=75 Participants	Group 2: Patients Without a HFE n=43 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at 1-month for RV Pacing Threshold	0.9 volts (V) Standard Deviation 0.5	1.4 volts (V) Standard Deviation 1.7

PRIMARY outcome

Timeframe: implant

Population: 56 CRT-D and 11 ICD patients had data available at implant

RA pacing threshold results were reported for implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=56 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for RA Pacing Threshold	0.8 volts (V) Standard Deviation 0.7	1.0 volts (V) Standard Deviation 0.7

PRIMARY outcome

Timeframe: pre-discharge

Population: 57 CRT-D and 11 ICD patients had data available at pre-discharge

RA pacing threshold results were reported at pre-discharge

Outcome measures

Measure	INCEPTA CRT-D Patients n=57 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for RA Pacing Threshold	0.8 volts (V) Standard Deviation 0.9	0.9 volts (V) Standard Deviation 0.8

PRIMARY outcome

Timeframe: 1-month

Population: 54 CRT-D and 11 ICD patients had data available at 1-month visit

RA pacing threshold results were reported at 1-month post-implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=54 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at 1-month for RA Pacing Threshold	1.0 volts (V) Standard Deviation 1.0	1.0 volts (V) Standard Deviation 0.7

PRIMARY outcome

Timeframe: implant

Population: 78 CRT-D patients had data available at implant

LV pacing impedance results at implant were measured in CRT-D.

Outcome measures

Measure	INCEPTA CRT-D Patients n=78 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant LV Pacing Impedance for CRT-D.	879 Ohms Standard Deviation 296	—

PRIMARY outcome

Timeframe: pre-discharge

Population: 75 CRT-D patients had data available at pre-discharge

LV pacing impedance results were reported for pre-discharge visit

Outcome measures

Measure	INCEPTA CRT-D Patients n=75 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for LV Pacing Impedance for CRT-D.	777 Ohms Standard Deviation 244	—

PRIMARY outcome

Timeframe: 1-month

Population: 73 CRT-D patients had data available at 1-month visit

LV pacing impedance results were reported at 1-month post-implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=73 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Clinical Performance at 1-month for LV Pacing Impedance for CRT-D.	778 Ohms Standard Deviation 265	—

PRIMARY outcome

Timeframe: implant

Population: 79 CRT-D and 46 ICD patients had data available at implant

RV pacing impedance results were reported at implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=79 Participants	Group 2: Patients Without a HFE n=46 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for RV Pacing Impedance	637 Ohms Standard Deviation 208	807 Ohms Standard Deviation 385

PRIMARY outcome

Timeframe: pre-discharge

Population: 78 CRT-D and 45 ICD patients had data available at pre-discharge

RV pacing impedance results were reported for pre-discharge

Outcome measures

Measure	INCEPTA CRT-D Patients n=78 Participants	Group 2: Patients Without a HFE n=45 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for RV Pacing Impedance	604 Ohms Standard Deviation 196	686 Ohms Standard Deviation 284

PRIMARY outcome

Timeframe: 1-month

Population: 75 CRT-D and 43 ICD patients had data available at 1-month visit

RV pacing impedance results were reported at 1-month post-implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=75 Participants	Group 2: Patients Without a HFE n=43 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at 1-month for RV Pacing Impedance	590 Ohms Standard Deviation 209	658 Ohms Standard Deviation 295

PRIMARY outcome

Timeframe: implant

Population: 56 CRT-D and 11 ICD patients had data available at implant

RA pacing impedance results were reported at implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=56 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Implant for RA Pacing Impedance	538 Ohms Standard Deviation 132	670 Ohms Standard Deviation 443

PRIMARY outcome

Timeframe: pre-discharge

Population: 57 CRT-D and 11 ICD patients had data available at pre-discharge

RA pacing impedance results were reported at pre-discharge

Outcome measures

Measure	INCEPTA CRT-D Patients n=57 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at Pre-discharge for RA Pacing Impedance	512 Ohms Standard Deviation 141	656 Ohms Standard Deviation 448

PRIMARY outcome

Timeframe: 1-month

Population: 54 CRT-D and 11 ICD patients had data available at 1-month

RA pacing impedance results were reported at 1-month post-implant

Outcome measures

Measure	INCEPTA CRT-D Patients n=54 Participants	Group 2: Patients Without a HFE n=11 Participants Patients who did not experience a protocol-defined HFE
Clinical Performance at 1-month for RA Pacing Impedance	534 Ohms Standard Deviation 152	655 Ohms Standard Deviation 447

PRIMARY outcome

Timeframe: Overall study results

Population: All patients from overall study population were considered. Of the total population, the number of product experiences was reported.

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=120 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Product Experiences Reported by the Site for All Patients for Study Duration	65 experiences	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=30 Participants	Group 2: Patients Without a HFE n=22 Participants Patients who did not experience a protocol-defined HFE
Induced Ventricular Tachycardia / Ventricular Fibrillation (VT/VF) Episode Successful Conversion Rates at Implant	100 percentage of successful conversions	100 percentage of successful conversions

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=1 Participants	Group 2: Patients Without a HFE n=1 Participants Patients who did not experience a protocol-defined HFE
Induced VT/VF Episode Successful Conversion Rates at 1-month	100 percentage of successful conversions	100 percentage of successful conversions

PRIMARY outcome

Timeframe: 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 %

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=6 Participants	Group 2: Patients Without a HFE n=3 Participants Patients who did not experience a protocol-defined HFE
Induced VT/VF Episode Successful Conversion Rates at 3-months	100 percentage of successful conversions	100 percentage of successful conversions

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=30 Participants	Group 2: Patients Without a HFE n=22 Participants Patients who did not experience a protocol-defined HFE
Induced Episode Detection Times at Implant	2.46 seconds Standard Deviation 0.38	2.40 seconds Standard Deviation 0.42

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=1 Participants	Group 2: Patients Without a HFE n=1 Participants Patients who did not experience a protocol-defined HFE
Induced Episode Detection Times at 1-month	2.06 seconds Standard Deviation 0	2.06 seconds Standard Deviation 0

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=6 Participants	Group 2: Patients Without a HFE n=3 Participants Patients who did not experience a protocol-defined HFE
Induced Episode Detection Times at 3 Months	2.28 seconds Standard Deviation 0.28	2.29 seconds Standard Deviation 0.06

PRIMARY outcome

Timeframe: 3-month

Population: Of the 13 CRT-D and 8 ICD patients that experienced a spontaneous episode, the successful conversions were reported.

Of the total patients that experienced a spontaneous episode, the % of patients with a spontaneous rhythm conversion that was successful was determined.

Outcome measures

Measure	INCEPTA CRT-D Patients n=54 Number of episodes	Group 2: Patients Without a HFE n=42 Number of episodes Patients who did not experience a protocol-defined HFE
Spontaneous Episode Conversion Success Rate at 3 Months	100 percentage of successful conversions	100 percentage of successful conversions

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	INCEPTA CRT-D Patients n=118 Participants	Group 2: Patients Without a HFE Patients who did not experience a protocol-defined HFE
Wanded Telemetry Issues at Pre-discharge Follow-up	1 issues	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	INCEPTA CRT-D Patients n=8 Participants	Group 2: Patients Without a HFE n=90 Participants Patients who did not experience a protocol-defined 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.	-0.30 breaths/min Interval -0.47 to 0.3	0 breaths/min Inter-Quartile Range 1.06 • Interval -0.4 to 0.8

Adverse Events

INCEPTA ICD and CRT-D

Serious events: 13 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	INCEPTA ICD and CRT-D n=120 participants at risk Patients implanted with Incepta ICD or CRT-D device
Cardiac disorders Lead Dislodgement, Left Ventricle	1.7% 2/120 • Number of events 3 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Lead Dislodgement, Right Atrium	1.7% 2/120 • Number of events 2 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Lead Dislodgement, Right Ventricle	1.7% 2/120 • Number of events 2 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Elevated Threshold, Right Atrium	0.83% 1/120 • Number of events 1 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Elevated Threshold, Right Ventricle	1.7% 2/120 • Number of events 2 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Insulation Breach, Right Atrium	0.83% 1/120 • Number of events 1 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Inadvertent Ventricular Tachycardia	0.83% 1/120 • Number of events 1 • 9 months (with a window of plus/minus 1 month)
Cardiac disorders Unable to Convert, Defibrillation Lead	0.83% 1/120 • Number of events 1 • 9 months (with a window of plus/minus 1 month)
Surgical and medical procedures Infection, Post-Surgical	0.83% 1/120 • Number of events 1 • 9 months (with a window of plus/minus 1 month)

Other adverse events

Measure	INCEPTA ICD and CRT-D n=120 participants at risk Patients implanted with Incepta ICD or CRT-D device
Cardiac disorders Extra Cardiac Stimulation, Left Ventricle	8.3% 10/120 • Number of events 10 • 9 months (with a window of plus/minus 1 month)

Additional Information

Paji Vitoff, Senior Clinical Manager

Guidant, a Boston Scientific Company

Phone: 651-582-5415

Email: paji.vitoff@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor shall be provided with copy of all Trial-related manuscripts and reports for review and comment
• Publication restrictions are in place

Restriction type: OTHER