Heart FailureRegiVeNCT04782232
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
An observational study of Heart Failure and Univentricular Heart, run by Berlin Heart GmbH at 1 site in Germany.
Trial summary
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Univentricular Heart, Ventricular Dysfunction
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.
Who may be able to join
- Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
- The indications on RVAD and BVAD use of the EXCOR VAD apply,
- Patient shall be on transplant list or at least eligible for HTx,
- BSA (body surface area) greater than or equal to 1.2 m².
Who cannot join
- Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
- The contraindications of EXCOR VAD apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
Read the detailed description
The registry study has an observational, prospective, international, multi-center, non-randomized design.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Being tested
- No intervention
- Keywords
- EXCOR Ventricular Assist Device, EXCOR Venous Cannula, Failing Fontan
- Medical subject headings
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention due to observational design
| Study group | Role | What they receive |
|---|---|---|
| Patients with failing/absence of the right heart | Patients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of mortality
Short-term mortality
Measured: 30 days
Rate of major bleeding
Short-term rate of major bleeding
Measured: 30 days
Rate of thrombosis
Short-term rate of thrombosis
Measured: 30 days
Survival to heart transplantation
Long-term survival to heart transplantation
Measured: up to 12 months
Secondary outcomes (1)
Rate of adverse events
Safety of the device
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jun 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 20 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Berlin Heart GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782232
- Sponsor's protocol ID
- E-20-325
- Acronym
- RegiVe
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2021
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dal Sasso E, Schondorf T, Schluter KJ, Miera O, De Rita F, Menon AK; European EXCOR(R) Pediatric Investigator Group (EEPIG). A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients. Thorac Cardiovasc Surg. 2022 Dec;70(S 03):e34-e41. doi: 10.1055/s-0042-1757916. Epub 2022 Nov 11.
PubMed 36368697
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
- ClinicalTrials.gov ID
- NCT04782232
- Acronym / sponsor ID
- RegiVe / E-20-325
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Keywords
- EXCOR Ventricular Assist Device, EXCOR Venous Cannula, Failing Fontan
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Berlin Heart GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 4 Mar 2021 (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 the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks and to assess clinical improvement on both short- and long-term.
Detailed description
The registry study has an observational, prospective, international, multi-center, non-randomized design.
The registry is planned for 42 months (3.5 years), with an enrollment period of 28 months, the follow-up of up to 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with failing/absence of the right heart | – | Other: No interventionPatients with acute or chronic, conservatively uncontrollable heart failure of varying pathogenesis, graded as stage III or IV according to NYHA, with an anticipated need for short-term to long-term right ventricular or biventricular support. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Twenty patients with failing/absence of the right heart. The indications on RVAD and BVAD use of the EXCOR VAD apply.
Key inclusion criteria (4 listed)
- Patient or his/her parent/guardian or legally authorized representative has given the consent by means of a written, signed and dated informed consent form,
- The indications on RVAD and BVAD use of the EXCOR VAD apply,
- Patient shall be on transplant list or at least eligible for HTx,
- BSA (body surface area) greater than or equal to 1.2 m².
Key exclusion criteria (2 listed)
- Patient or his/her parents/legal guardian or legally authorized guardian has not given the consent,
- The contraindications of EXCOR VAD apply.
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 |
|---|---|---|
| No interventionNo intervention due to observational design | Other | Patients with failing/absence of the right heart |
Primary outcome
Rate of mortality
Time frame: 30 days
Short-term mortality
Rate of major bleeding
Time frame: 30 days
Short-term rate of major bleeding
Rate of thrombosis
Time frame: 30 days
Short-term rate of thrombosis
Survival to heart transplantation
Time frame: up to 12 months
Long-term survival to heart transplantation
1 secondary outcome
Rate of adverse events
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 36368697Dal Sasso E, Schondorf T, Schluter KJ, Miera O, De Rita F, Menon AK; European EXCOR(R) Pediatric Investigator Group (EEPIG). A Novel Strategy for the Mechanical Subpulmonary Support in Failing Fontan Patients. Thorac Cardiovasc Surg. 2022 Dec;70(S 03):e34-e41. doi: 10.1055/s-0042-1757916. Epub 2022 Nov 11.
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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.
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 Heart Failure and Univentricular Heart, run by Berlin Heart GmbH at 1 site in Germany.
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 4 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Schöndorf, Dr. Dr. PD (+49 30 81872600, clinical.science@berlinheart.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mortality (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782232, which also lists 1 linked publication.
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 17 Feb 2025.