Mitral RegurgitationHRTNCT03511716
Observational Study of the Heart Repair Technologies Mitral Bridge in Treating Mitral Valve Regurgitation
An observational study of Mitral Regurgitation, run by Heart Repair Technologies, Inc. at 1 site in Czechia.
Trial summary
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- HRT Mitral Bridge Mitral Valve Repair
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteCzechia
- Study dates
- 6 Feb 2014to 31 Aug 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 21 with moderate to severe, functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair
Who may be able to join
- Patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass
- Mitral regurgitation must meet the following criteria:
- The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve.
- If a secondary jet is present, the jet must be considered clinically insignificant.
- Women of child-bearing potential have a negative pregnancy test
Who cannot join
- Evidence of severe mitral annular and leaflet calcification.
- Patient is hemodynamically unstable.
- Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets.
- Patient requires emergency surgery.
- Patient has echocardiographic evidence of endocarditis or rheumatic heart disease.
- Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed intraoperatively for any reason.
Show all 16Show fewer
- Patient has known chronic, dialysis-dependent renal failure.
- History of stroke, transient ischemic attack (TIA) or reversible ischemic neurological disease within the last three (3) months.
- History of gastrointestinal bleeding within the last three (3) months.
- History of hypersensitivity or allergy to aspirin
- History or hypersensitivity to clopidogrel (Plavix) or its congeners.
- Active or treated malignancies in the last twelve (12) months.
- Patient is participating in another clinical study for which follow-up is currently ongoing.
- Women of child-bearing age who have not had a negative pregnancy test.
- Patient with non-cardiac co-morbidities and life expectancy < 1 year.
- Patient has a condition that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.
Read the detailed description
The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane.
The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.
- Conditions
- Mitral Regurgitation
- Being tested
- HRT Mitral Bridge Mitral Valve Repair
- Keywords
- Mitral Insufficiency, Mitral Valve Incompetence
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRT Mitral Bridge Mitral Valve RepairDevice
Surgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
- Freedom from subsequent open mitral valve repair or replacement
Measured: One, 3, 6,12, 24, 36, 48, and 60 months
Secondary outcomes (2)
Preservation or improvement of left ventricular remodeling
Change in Left Ventricular status
Measured: One, 3, 6,12, 24, 36, 48, and 60 months
Preservation of improvement in NYHA (New York Heart Association) functional class.
Change in NYHA (New York Heart Association) functional class.
Measured: One, 3, 6,12, 24, 36, 48, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start6 Feb 2014
- Primary completionAug 2019
- Study completion31 Aug 2019
Why it stopped: Could not enroll enough patients and ran out of $$ to manufacture more devices
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 Mitral RegurgitationStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Repair Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Na Homolce Hospital
- Responsible party
- Sponsor
- Investigators
- Štěpán ČERNÝ, MD, PhD, MBA, Principal investigator, Cardiac Surgeon, Head of Hybrid Operating Room,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511716
- Sponsor's protocol ID
- HRT Mitral Bridge
- Acronym
- HRT
- Status last verified
- Aug 2019
- First submitted
- 9 Apr 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerny S, Benesova M, Skalsky I, Patel NC, Subramanian VA. Persistent reduction of mitral regurgitation by implantation of a transannular mitral bridge: durability and effectiveness of the repair at 2 years-results of a prospective trialdagger. Eur J Cardiothorac Surg. 2019 May 1;55(5):867-873. doi: 10.1093/ejcts/ezy423.
PubMed 30590416
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRT Observational Study of a Mitral Bridge in Patients With Moderate to Severe Mitral Valve Regurgitation to Evaluate Device Safety and Performance
- ClinicalTrials.gov ID
- NCT03511716
- Acronym / sponsor ID
- HRT / HRT Mitral Bridge
- Conditions
- Mitral Regurgitation
- Keywords
- Mitral Insufficiency, Mitral Valve Incompetence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Could not enroll enough patients and ran out of $$ to manufacture more devices
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Heart Repair Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Na Homolce Hospital
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 30 Apr 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.
Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.
Detailed description
The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane.
The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 21 with moderate to severe, functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair
Key inclusion criteria (5 listed)
- Patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass
- Mitral regurgitation must meet the following criteria:
- The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve.
- If a secondary jet is present, the jet must be considered clinically insignificant.
- Women of child-bearing potential have a negative pregnancy test
Key exclusion criteria (16 listed)
- Evidence of severe mitral annular and leaflet calcification.
- Patient is hemodynamically unstable.
- Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets.
- Patient requires emergency surgery.
- Patient has echocardiographic evidence of endocarditis or rheumatic heart disease.
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 |
|---|---|---|
| HRT Mitral Bridge Mitral Valve RepairSurgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane | Device | – |
Primary outcome
Clinical Success
Time frame: One, 3, 6,12, 24, 36, 48, and 60 months
- Freedom from subsequent open mitral valve repair or replacement
2 secondary outcomes
Preservation or improvement of left ventricular remodeling
Time frame: One, 3, 6,12, 24, 36, 48, and 60 months
Preservation of improvement in NYHA (New York Heart Association) functional class.
Time frame: One, 3, 6,12, 24, 36, 48, and 60 months
Results and safety
The study was stopped early (reason given: Could not enroll enough patients and ran out of $$ to manufacture more devices). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 30590416Cerny S, Benesova M, Skalsky I, Patel NC, Subramanian VA. Persistent reduction of mitral regurgitation by implantation of a transannular mitral bridge: durability and effectiveness of the repair at 2 years-results of a prospective trialdagger. Eur J Cardiothorac Surg. 2019 May 1;55(5):867-873. doi: 10.1093/ejcts/ezy423.
- 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.
Štěpán ČERNÝ, MD, PhD, MBA principal investigator
Cardiac Surgeon, Head of Hybrid Operating Room,
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 Mitral Regurgitation, run by Heart Repair Technologies, Inc. at 1 site in Czechia.
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 5 inclusion and 16 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: stopped early, as of the sponsor's last update on 8 Oct 2020. 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 Czechia. 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?
The study was stopped early (reason given: Could not enroll enough patients and ran out of $$ to manufacture more devices). 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?
Clinical Success (time frame: One, 3, 6,12, 24, 36, 48, and 60 months). 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 NCT03511716, 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 8 Oct 2020.