Ventricular DysfunctionNCT03701997
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
An observational study of Ventricular Dysfunction and Ventricular Dysfunction, Left, run by Berlin Heart, Inc at 1 site in United States.
Trial summary
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
- What is being tested?
- EXCOR Pediatric
- Type of treatment
- Medical device
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to May 2022
- How long will I take part?
- 1 Year
- 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: Pediatric (0-21 years) who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
Who may be able to join
- Transplant eligible
- Implanted with EXCOR Pediatric per IFU
Who cannot join
- Having any contradictions for user per IFU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.
Read the detailed description
The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.
- Being tested
- EXCOR Pediatric
- Medical subject headings
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
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, EXCOR
Mechanical circulatory support using ventricular assist device
| Study group | Role | What they receive |
|---|---|---|
| EXCOR Pediatric | Pediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric Receives: Device: EXCOR Pediatric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke rate
The primary endpoint is to demonstrate that the rate of stroke (ischemic or hemorrhagic) will be no worse than the pre-specified performance goal. The rate will be calculated as the proportion of subjects experiencing a stroke while on EXCOR® Pediatric support within the first 180 days post-implant. The upper bound of the 95% confidence interval for the observed stroke rate will be compared to the pre-specified performance goal of 30%.
Measured: Until discontinuation of device support or 180 days
Secondary outcomes (2)
Adverse Events
Adverse Event rates per patient-month
Measured: Until discontinuation of device support or 180 days
Device effectiveness
Proportion of subjects experiencing a successful (transplant, wean for recovery) outcome
Measured: Until discontinuation of device support or 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start15 Oct 2018 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 62 participants (estimated)
- Target duration
- 1 Year
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
- NCT03701997
- Sponsor's protocol ID
- EXCOR PMA Post Approval
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-comers Registry Monitoring the Safety and Effectiveness of the Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
- ClinicalTrials.gov ID
- NCT03701997
- Acronym / sponsor ID
- EXCOR PMA Post Approval
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Berlin Heart, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 10 Oct 2018 (actual)
- 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 market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric. This surveillance includes an "all-comers" prospective cohort of pediatric (<22 years of age) patients implanted according to the IFU with the EXCOR® Pediatric.
Detailed description
The Advanced Cardiac Therapies Improving Outcomes Network (Action) database will be used for the surveillance. The network was developed to determine best practice and improve quality in the pediatric mechanical circulatory support field. The registry Protocol and Manual of Operations will be followed by participating pediatric transplant hospitals. Quality assurance of the data will be monitored by the registry's data coordinating center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXCOR Pediatric | – | Device: EXCOR PediatricPediatric (age 0 - 21) patients who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric (0-21 years) who are transplant eligible in need of mechanical circulatory support and are supported with the EXCOR® Pediatric
Key inclusion criteria (2 listed)
- Transplant eligible
- Implanted with EXCOR Pediatric per IFU
Key exclusion criteria (1 listed)
- Having any contradictions for user per IFU
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 Pediatric, EXCORMechanical circulatory support using ventricular assist device | Device | EXCOR Pediatric |
Primary outcome
Stroke rate
Time frame: Until discontinuation of device support or 180 days
The primary endpoint is to demonstrate that the rate of stroke (ischemic or hemorrhagic) will be no worse than the pre-specified performance goal. The rate will be calculated as the proportion of subjects experiencing a stroke while on EXCOR® Pediatric support within the first 180 days post-implant. The upper bound of the 95% confidence interval for the observed stroke rate will be compared to the pre-specified performance goal of 30%.
2 secondary outcomes
Adverse Events
Time frame: Until discontinuation of device support or 180 days
Device effectiveness
Time frame: Until discontinuation of device support or 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Dysfunction and Ventricular Dysfunction, Left, run by Berlin Heart, Inc at 1 site in United States.
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 1 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Stroke rate (time frame: Until discontinuation of device support or 180 days). 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 10 Oct 2018.