Severe Isolated Left Ventricular DysfunctionNCT01674699
Berlin Heart EXCOR Pediatric Post Approval Study
An observational study of Severe Isolated Left Ventricular Dysfunction and Severe Biventricular Dysfunction, run by Berlin Heart, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Severe Isolated Left Ventricular Dysfunction, Severe Biventricular Dysfunction
- What is being tested?
- EXCOR Pediatric
- Type of treatment
- Medical device
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. 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.
Study Purpose 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. Because the device had extensive use (available to all North American sites who requested the device under compassionate use regulations), it is expected that the pre-approval and post-approval use will be similar.
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.
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.
The following secondary objectives will be summarized:
- Device Malfunction
- Site evaluation of explanted pumps for suspected thrombus
- Assessment of the learning curve
The study will be an "all-comers" prospective study maintained by the sponsor consisting of pediatric patients aged 0-21 years implanted according to the IFU with the EXCOR® Pediatric who are transplant eligible children in need of mechanical circulatory support and who consent to be enrolled into the study.
The study will enroll at least 39 subjects implanted with the device per device labeling and who consent to be enrolled into the post approval study after the study commencement at any implanting site with IRB approval for participation.
Study enrollment is expected to take 10-12 months and subjects will be followed until they reach an outcome. The primary endpoints will be analyzed and reported to FDA during the regular reporting cycle. Explanted subjects will be followed for 24 months post explant. A final report will be submitted to FDA once all subjects complete their 24 month post explant visit. Average time on device is expected to be similar to the average time on the device during the IDE study (58 days) therefore the last implant is expected to be followed until outcome (IDE range was 0 - 435 days). The overall study duration is expected to be approximately 36-38 months.
- Being tested
- EXCOR Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXCOR PediatricDevice
Also called EXCOR Pediatric VAD, EXCOR Pediatric Ventricular Assist Device, Berlin Heart EXCOR Pediatric
Ventricular Assist Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EXCOR Pediatric |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Isolated Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berlin Heart, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert M Kroslowitz, BS, Study director, Berlin Heart, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674699
- Sponsor's protocol ID
- EXCOR PAS
- Other IDs
- H100004
- Status last verified
- Aug 2012
- First submitted
- 27 Aug 2012
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Berlin Heart EXCOR Pediatric Post Approval Study
- ClinicalTrials.gov ID
- NCT01674699
- Acronym / sponsor ID
- EXCOR PAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Berlin Heart, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 29 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
EXCOR® Pediatric is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. 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.
Study Purpose 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. Because the device had extensive use (available to all North American sites who requested the device under compassionate use regulations), it is expected that the pre-approval and post-approval use will be similar.
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.
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.
The following secondary objectives will be summarized:
- Device Malfunction
- Site evaluation of explanted pumps for suspected thrombus
- Assessment of the learning curve
The study will be an "all-comers" prospective study maintained by the sponsor consisting of pediatric patients aged 0-21 years implanted according to the IFU with the EXCOR® Pediatric who are transplant eligible children in need of mechanical circulatory support and who consent to be enrolled into the study.
The study will enroll at least 39 subjects implanted with the device per device labeling and who consent to be enrolled into the post approval study after the study commencement at any implanting site with IRB approval for participation.
Study enrollment is expected to take 10-12 months and subjects will be followed until they reach an outcome. The primary endpoints will be analyzed and reported to FDA during the regular reporting cycle. Explanted subjects will be followed for 24 months post explant. A final report will be submitted to FDA once all subjects complete their 24 month post explant visit. Average time on device is expected to be similar to the average time on the device during the IDE study (58 days) therefore the last implant is expected to be followed until outcome (IDE range was 0 - 435 days). The overall study duration is expected to be approximately 36-38 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXCOR | – | Device: EXCOR PediatricPediatric 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. |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXCOR PediatricAlso: EXCOR Pediatric VAD, EXCOR Pediatric Ventricular Assist Device, Berlin Heart EXCOR PediatricVentricular Assist Device | Device | EXCOR |
Primary outcome
Safety
Time frame: 2 years
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.
Effectiveness
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Kroslowitz, BS study director
Berlin Heart, Inc
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Isolated Left Ventricular Dysfunction and Severe Biventricular Dysfunction, run by Berlin Heart, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.