Degenerative Mitral Valve DiseaseNCT04281940
Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
A study testing Transcatheter implantation of chordal repair system in people with Degenerative Mitral Valve Disease and Mitral Valve Regurgitation, run by Pipeline Medical at 4 sites in 3 countries.
Trial summary
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
- What is being tested?
- Transcatheter implantation of chordal repair system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 18 Mar 2022to 1 May 2024
- Phase
- Interventional
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of moderate to severe Mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure.
- Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating physician and the patient eligibility committee.
- Degenerative mitral valve disease.
- Patients who have been evaluated and no contraindication has been found for open heart surgery OR candidates for mitral valve surgery who, according to current guidelines, are at elevated surgical risk AND for whom transcatheter therapy is deemed more appropriate than open heart surgery in the judgement of the Site Heart Team.
Who cannot join
- Untreated clinically significant coronary artery disease requiring revascularization
- Creatine Kinase-MB (CK-MB) obtained within prior 14 days > local laboratory Upper Limit of Normal (ULN)
- Age <30/40 or > 85 years
- Presence of any of the following:
- Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, ischemic or non-ischemic Functional mitral regurgitation or any other structural heart disease causing heart failure
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- Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device
- Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
- Left Ventricular Ejection Fraction (LVEF) is < 30% (within 90 days prior to subject enrollment, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI))
- Mitral annular diameter >45mm in any dimension. Left Ventricular End Diastolic Diameter (LVEDD) > 65mm. Left Ventricular End Systolic Dimension (LVESD) > 55 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject enrollment
- Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent
- Percutaneous coronary intervention within 30 days prior to subject's consent
- Tricuspid valve disease requiring surgery
- Aortic valve disease requiring surgery or TAVI
- Carotid surgery within 30 days prior to subject's consent
- Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30 days prior to subject's consent
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- Status 1 heart transplant or prior orthotopic heart transplantation
- Chronic Kidney Disease with a baseline serum creatinine > 1.5mg/dL
- Chronic Steroid Therapy
- Cerebrovascular accident within 30 days prior to subject's consent
- Severe symptomatic carotid stenosis (> 70 % via ultrasound)
- Life expectancy < 12 months due to non-cardiac conditions
- Active infections requiring current antibiotic therapy
- Pregnant or planning pregnancy within next 12 months
- Currently participating in an investigational drug or another device study
- Severe organic lesions with mitral chords retraction, severely fibrotic and immobile leaflets, severely deformed subvalvular apparatus
- Evolving endocarditis or active endocarditis in the last 3 months
- Heavily calcified or dilated annulus or leaflets, mitral valve stenosis
- Congenital malformation with limited valvular tissue
- Patient requires mitral valve replacement
- Previously implanted prosthetic mitral valve or annuloplasty ring/band
- Evidence of LV or LA thrombus, vegetation or mass
- Severe tricuspid regurgitation or severe RV dysfunction
- Condition that prevents transfemoral access
- Anatomical ineligibility to the investigational device
- Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Serbia2 sites
Institute for Cardiovascular Diseases Dedinje
Belgrade, 11040
Institute for Cardiovascular Diseases Vojvodina
Kamenitz, 21204
Georgia1 site
Israeli-Georgian Medical Research Clinic Healthycore, LTD
Tbilisi, 0112
About this study
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
Read the detailed description
The proposed study is a prospective, multi-center, interventional investigation enrolling up to 30 subjects in multiple sites in Latin America and Eastern Europe.
The primary objective of this study is to collect preliminary information on the performance and safety of the Pipeline Chordal Repair System in percutaneous reduction of significant mitral regurgitation (MR ≥ moderate) due to primary abnormality of the mitral apparatus [degenerative MR].
- Being tested
- Transcatheter implantation of chordal repair system
- 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.
Transcatheter implantation of chordal repair systemDevice
Implantation of anchor via transcatheter delivery system to delivery chordal repair system tethering the mitral leaflets to the ventricle
| Study group | Role | What they receive |
|---|---|---|
| Permanent Implant | Experimental | Insertion of the Chordal Repair System tethering the mitral leaflets to the left ventricle. Receives: Device: Transcatheter implantation of chordal repair system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.
Primary Safety
Measured: Procedure through 30 days post procedure
Freedom from device-related Major Adverse Events (MAE), defined as a combined clinical endpoint of death, reoperation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke or renal failure
Primary Safety
Measured: Procedure through 30 days post procedure
Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle
Technical Success
Measured: Procedure
Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.
Procedural Success
Measured: Procedure through 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start18 Mar 2022
- Primary completion7 Jun 2023
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral Valve DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pipeline Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281940
- Sponsor's protocol ID
- CIP-0001
- Status last verified
- Oct 2024
- First submitted
- 20 Feb 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chordal Repair for Transcatheter Mitral Valve Repair (TMVr)
- ClinicalTrials.gov ID
- NCT04281940
- Acronym / sponsor ID
- CIP-0001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pipeline MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 24 Feb 2020 (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.
A multi-center evaluation of the Pipeline chordal repair system for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve repair.
Detailed description
The proposed study is a prospective, multi-center, interventional investigation enrolling up to 30 subjects in multiple sites in Latin America and Eastern Europe.
The primary objective of this study is to collect preliminary information on the performance and safety of the Pipeline Chordal Repair System in percutaneous reduction of significant mitral regurgitation (MR ≥ moderate) due to primary abnormality of the mitral apparatus [degenerative MR].
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Permanent Implant | Experimental | Device: Transcatheter implantation of chordal repair systemInsertion of the Chordal Repair System tethering the mitral leaflets to the left ventricle. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Presence of moderate to severe Mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure.
- Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating physician and the patient eligibility committee.
- Degenerative mitral valve disease.
- Patients who have been evaluated and no contraindication has been found for open heart surgery OR candidates for mitral valve surgery who, according to current guidelines, are at elevated surgical risk AND for whom transcatheter therapy is deemed more appropriate than open heart surgery in the judgement of the Site Heart Team.
Key exclusion criteria (40 listed)
- Untreated clinically significant coronary artery disease requiring revascularization
- Creatine Kinase-MB (CK-MB) obtained within prior 14 days > local laboratory Upper Limit of Normal (ULN)
- Age <30/40 or > 85 years
- Presence of any of the following:
- Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization
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 |
|---|---|---|
| Transcatheter implantation of chordal repair systemImplantation of anchor via transcatheter delivery system to delivery chordal repair system tethering the mitral leaflets to the ventricle | Device | Permanent Implant |
Primary outcome
Safety at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days.
Time frame: Procedure through 30 days post procedure
Primary Safety
Freedom from device-related Major Adverse Events (MAE), defined as a combined clinical endpoint of death, reoperation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke or renal failure
Time frame: Procedure through 30 days post procedure
Primary Safety
Technical successful transcatheter implantation of the Chordal Repair System tethering the mitral leaflets to the ventricle
Time frame: Procedure
Technical Success
Procedural success defined as the successful implant of the device resulting in MR severity of < moderate at 30 days as confirmed by echocardiography.
Time frame: Procedure through 30 days post procedure
Procedural Success
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Degenerative Mitral Valve Disease
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ATLAS (AltaValve) Pivotal Trial
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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
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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.
Adrian Ebner, MD principal investigator
Principal Investigator
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter implantation of chordal repair system in people with Degenerative Mitral Valve Disease and Mitral Valve Regurgitation, run by Pipeline Medical at 4 sites in 3 countries.
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 40 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: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Serbia, Georgia, Paraguay. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 at 30 days: freedom from death or intervention resulting from valve dysfunction or the implant procedure at 30 days. (time frame: Procedure through 30 days post procedure). 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?
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 15 Oct 2024.