Trial Outcomes & Findings for Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device (NCT NCT00583661)

Last Updated: 2013-03-15

Results Overview

The serious adverse event rate was calculated by totaling the number of serious adverse events all subjects experienced during device support (from implant to explant, an average of 58 days) divided by the total support time (in days) for all subjects. The serious adverse event rates were calculated separately for each primary study cohort.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

Participants were followed while on device support, an average of 58 days

Results posted on

2013-03-15

Participant Flow

Subject were recruited at pediatric transplant centers by the implanting physicians.

Participant milestones

Participant milestones
Measure	EXCOR Pediatric Implantation of the EXCOR Pediatric Ventricular Assist Device
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EXCOR Pediatric n=48 Participants Implantation of the EXCOR Pediatric Ventricular Assist Device
Age, Categorical <=18 years	48 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	64.3 Months n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants
Region of Enrollment Canada	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were followed while on device support, an average of 58 days

Population: All 48 participants were included in the analysis. Adverse Events for each participant was counted and the total number of events was divided by the total time the Cohort's subjects were supported on device. A 95% Poisson confidence interval was calculated around the point estimates.

Outcome measures

Outcome measures
Measure	Cohort 1 n=24 Participants Subjects with Body Surface Area \< 0.7m\^2	Cohort 2 n=24 Participants Subjects with Body Surface Area 0.7-1.5m\^2
The Safety of EXCOR® Pediatric Was Evaluated by Summarizing the Serious Adverse Event Rate Experienced While the Subject Was Supported on the Device.	0.068 Events per patient-day Interval 0.055 to 0.083	0.066 Events per patient-day Interval 0.053 to 0.081

PRIMARY outcome

Timeframe: Participants were followed while on device support, an average of 58 days

Population: All subjects implanted with the device were included in this analysis.

Efficacy of the EXCOR® Pediatric was estimated by showing survival of all participants who were supported by the device.

Outcome measures

Outcome measures
Measure	Cohort 1 n=24 Participants Subjects with Body Surface Area \< 0.7m\^2	Cohort 2 n=24 Participants Subjects with Body Surface Area 0.7-1.5m\^2
Efficacy of the EXCOR® Pediatric Was Estimated by Showing Survival of All Participants Who Were Supported by the Device.	21 participants	22 participants

Adverse Events

EXCOR Pediatric

Serious events: 41 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EXCOR Pediatric n=48 participants at risk Implantation of the EXCOR Pediatric Ventricular Assist Device
Surgical and medical procedures Bleeding	45.8% 22/48 • Number of events 22 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Cardiac disorders Cardiac Arrhythmia	10.4% 5/48 • Number of events 5 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Surgical and medical procedures Pericardial Fluid Collection	12.5% 6/48 • Number of events 6 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Blood and lymphatic system disorders Hemolysis	4.2% 2/48 • Number of events 2 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Hepatobiliary disorders Hepatic Dysfunction	4.2% 2/48 • Number of events 2 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Cardiac disorders Hypertension	41.7% 20/48 • Number of events 20 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Infections and infestations Infection	56.2% 27/48 • Number of events 27 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Nervous system disorders Neurological Dysfunction	29.2% 14/48 • Number of events 14 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Psychiatric disorders Psychiatric Episode	2.1% 1/48 • Number of events 1 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Renal and urinary disorders Renal Dysfunction	10.4% 5/48 • Number of events 5 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	18.8% 9/48 • Number of events 9 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Cardiac disorders Right Heart Failure	10.4% 5/48 • Number of events 5 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Vascular disorders Arterial Non-CNS Thromboembolism	2.1% 1/48 • Number of events 1 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.
Vascular disorders Venous Thromboembolism Event	2.1% 1/48 • Number of events 1 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.

Other adverse events

Other adverse events
Measure	EXCOR Pediatric n=48 participants at risk Implantation of the EXCOR Pediatric Ventricular Assist Device
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.2% 3/48 • Number of events 3 • Adverse events were recorded during the time the subject was being supported on the device, an average of 58 days. Subjects were hospitalized while on device and serious adverse events were assessed on an on-going basis. All reported events were adjudicated by an independent Clinical Events Committee.

Additional Information

Robert Kroslowitz, CEO

Berlin Heart Inc.

Phone: 1-281-863-9700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI has agreed to discuss or publish trial results only after review by the Publication Committee and the sponsor.
Publication restrictions are in place

Restriction type: OTHER