Berlin Heart EXCOR Pediatric Post Approval Study

NCT01674699 | Unknown

• 2 other identifiers: EXCOR PASH100004
• Study Type: observational
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE study.

Conditions

Severe Isolated Left Ventricular Dysfunction; Severe Biventricular Dysfunction

Outcome Measures

Primary Outcomes (2)

• Safety

  The primary safety objective of the EXCOR® Pediatric VAD Post-Approval Study is to demonstrate that the serious adverse event (SAE) rate in subjects implanted with the EXCOR® Pediatric in the study is not greater than the rate experienced in the IDE study.

  2 years

• Effectiveness

  The primary effectiveness objective for the EXCOR® Pediatric VAD Post Approval Study is to assess the outcome following implantation of the EXCOR® Pediatric for transplant eligible children in need of mechanical circulatory support. Outcome is defined as transplant, recovery of left ventricular function or death.

  2 years

Study Arms (1)

EXCOR

Pediatric candidates age 0 - 21 with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR® Pediatric.

Device: EXCOR Pediatric

Interventions

EXCOR Pediatric DEVICE

Ventricular Assist Device

Also known as: EXCOR Pediatric VAD, EXCOR Pediatric Ventricular Assist Device, Berlin Heart EXCOR Pediatric

EXCOR

Eligibility Criteria

• Age: 1 Day - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be an "all-comers" prospective study including subjects whom meet the Inclusion and Exclusion Criteria. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR® Pediatric.

You may qualify if:

• Patient requires mechanical circulatory support and is eligible for cardiac transplantation
• Legal guardian and patient (if age appropriate) understands the nature of the implant procedure and are willing to comply with associated follow-up evaluations, and provide written informed consent and assent prior to the procedure

You may not qualify if:

• Patient is currently enrolled in EXCOR® Pediatric pre-market study
• Patient is currently participating in another investigational device or drug trial which would confound the results of the study

Sponsors & Collaborators

• Berlin Heart, Inc: lead

Study Officials

• Robert M Kroslowitz, BS

  Berlin Heart, Inc

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 29, 2012

Record last verified: 2012-08