Mitral Valve ProlapseNCT07103733
PRIMARY Ancillary Substudy
A study testing Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring and Myocardial Tissue Biopsy in people with Mitral Valve Prolapse and Left Ventricular Fibrosis, run by Annetine Gelijns at 25 sites in 3 countries.
Trial summary
The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mitral Valve Prolapse, Left Ventricular Fibrosis, Ventricular Arrhythmias
- What is being tested?
- Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring and Myocardial Tissue Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 16 Oct 2023to 30 Jun 2027
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.
- For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.
Who cannot join
- Severe claustrophobia not controlled with sedation.
- Prior adverse reaction to gadolinium administration.
- Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.
- Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
United States16 sites
University of Michigan Hospital
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Atlanta, Georgia, 30309
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia Medical Center
Charlottesville, Virginia, 22908
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Hospital
Durham, North Carolina, 27710
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, 64111
Keck Hospital of the University of Southern California
Los Angeles, California, 90033
Cedars-Sinai
Los Angeles, California, 90048
West Virginia University Hospital
Morgantown, West Virginia, 26506
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, 10065
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
New York, New York, 10075
Maine Medical Center
Portland, Maine, 04102
University of California San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
United Kingdom7 sites
The Leeds Teaching Hospitals NHS Trust
Leeds, England, LS9 7TF
South Tees Hospitals NHS Foundation Trust
Marton-in-Cleveland, Middlesbrough
Manchester University NHS Foundation Trust
Oxford, Manchester
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 9DU
Royal Papworth Hospital NHS Foundation Trust
Trumpington, Cambridge
Barts Health NHS Trust
Whitechapel, London
University Hospitals Sussex NHS Foundation Trust
Worthing, West Sussex, BN11 2DH
Germany2 sites
Deutsches Herzzentrum der Charité
Berlin, 13353
Herzzentrum Leipzig
Leipzig, 04289
About this study
Official title: Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy
The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.
Read the detailed description
This is an ancillary study of a multicenter randomized clinical trial comparing MVr to TEER for degenerative mitral regurgitation (MR) involving up to 250 patients from the parent trial. All patients will receive rhythm monitoring, up to 200 patients will receive pre/post intervention CMR, all patients in the parent trial will undergo a transthoracic echocardiogram (TTE) (as part of the randomized controlled trial (RCT)), and 60 surgical patients will undergo tissue biopsies. The study is being conducted in highly experienced clinical centers in the U.S., Canada, Germany, the U.K. and Spain. The estimated enrollment period is 12-18 months. Outcomes will be measured from baseline to 12 months after randomization.
This mechanistic ancillary study has the following aims:
- To compare the impact of MVr and TEER on disordered ventricular biomechanics and myocardial fibrosis that predispose to ventricular arrhythmias, using speckle tracking strain echocardiography, cardiac magnetic resonance imaging (CMR), and rhythm monitoring pre- and post-mitral valve (MV) intervention. The research team hypothesize's that a treatment strategy that more effectively and durably reduces MVP and MR will lead to improved ventricular mechanics, limit progression of myocardial fibrosis and decrease the burden of ventricular arrhythmias and HF.
- To compare the impact of MVr and TEER on recurrent/residual MR, LV and left atrial (LA) reverse remodeling with baseline and 1-year post-intervention CMR, and to use quantitative CMR myocardial tissue phenotyping as a predictor of response to MVr and TEER.
- To construct functional pre-operative CMR fingerprints that recapitulate the mechanical state of the heart to develop individualized computational models, which will be altered in silico based on the proposed treatment plan, to predict patients' response to therapy. These results will be validated against post-operative outcome data to test the validity of this approach for predicting treatment response.
- To explore the relationships among gene products, structural variables, and post-operative clinical outcomes, including reverse remodeling, using tissue obtained at surgery from ventricular myocardium.
- Being tested
- Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring, Myocardial Tissue Biopsy
- Keywords
- Mitral valve repair (MVr), Transcatheter-edge-to-edge-repair (TEER), Cardiac magnetic resonance imaging (CMR), ZioPatch monitoring, Heart biopsy
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingProcedure or surgery
Also called CMR
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch MonitoringDevice
Also called iRhythm Monitoring
ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.
Myocardial Tissue BiopsyProcedure or surgery
Also called Heart Bioplsy
During the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur.
| Study group | Role | What they receive |
|---|---|---|
| Mitral valve repair | Active comparator | Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Receives: Procedure: Cardiac Magnetic Resonance Imaging; Device: ZioPatch Monitoring; Procedure: Myocardial Tissue Biopsy |
| Transcatheter edge-to-edge repair | Active comparator | Patients will be treated with a commercially-approved edge-to-edge mitral repair device. Receives: Procedure: Cardiac Magnetic Resonance Imaging; Device: ZioPatch Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Myocardial Fibrosis
Myocardial fibrosis is the buildup of excess fibrous connective tissue in the heart muscle often resulting from chronic injury or stress. It can impair the heart's ability to contract and relax properly leading to reduced cardiac function.
Measured: 1 year post index procedure.
Presence of Ventricular Arrythmia
A ventricular arrhythmia is an abnormal heart rhythm that starts in the lower chambers of the heart (the ventricles). It can cause the heart to beat too fast, which may reduce blood flow to the body and, in some cases, be life-threatening.
Measured: 1 year post index procedure.
Proteomics
Proteomics is the large-scale study of proteins, which are essential molecules that carry out most functions in the body. By analyzing proteins in tissues or fluids, scientists can better understand diseases, identify biomarkers, and discover new treatment targets.
Measured: 1 year post index procedure.
Secondary outcomes (1)
Computational and Predictive Models of Treatment Outcome
specific treatment. These tools help doctors make more personalized and effective care decisions based on patterns found in large sets of medical information.
Measured: 1 year post index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start16 Oct 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annetine Gelijns
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Annetine Gelijns, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanna Chikwe, MD, Study director, Cedars-SinaiMartin Leon, MD, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103733
- Sponsor's protocol ID
- GCO 08-1078 ANC
- Other IDs
- 5U01HL088942-17
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data shared will be in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy
- ClinicalTrials.gov ID
- NCT07103733
- Acronym / sponsor ID
- GCO 08-1078 ANC
- Keywords
- Mitral valve repair (MVr), Transcatheter-edge-to-edge-repair (TEER), Cardiac magnetic resonance imaging (CMR), ZioPatch monitoring, Heart biopsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Annetine GelijnsUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Aug 2025 (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 PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.
Detailed description
This is an ancillary study of a multicenter randomized clinical trial comparing MVr to TEER for degenerative mitral regurgitation (MR) involving up to 250 patients from the parent trial. All patients will receive rhythm monitoring, up to 200 patients will receive pre/post intervention CMR, all patients in the parent trial will undergo a transthoracic echocardiogram (TTE) (as part of the randomized controlled trial (RCT)), and 60 surgical patients will undergo tissue biopsies. The study is being conducted in highly experienced clinical centers in the U.S., Canada, Germany, the U.K. and Spain. The estimated enrollment period is 12-18 months. Outcomes will be measured from baseline to 12 months after randomization.
This mechanistic ancillary study has the following aims:
- To compare the impact of MVr and TEER on disordered ventricular biomechanics and myocardial fibrosis that predispose to ventricular arrhythmias, using speckle tracking strain echocardiography, cardiac magnetic resonance imaging (CMR), and rhythm monitoring pre- and post-mitral valve (MV) intervention. The research team hypothesize's that a treatment strategy that more effectively and durably reduces MVP and MR will lead to improved ventricular mechanics, limit progression of myocardial fibrosis and decrease the burden of ventricular arrhythmias and HF.
- To compare the impact of MVr and TEER on recurrent/residual MR, LV and left atrial (LA) reverse remodeling with baseline and 1-year post-intervention CMR, and to use quantitative CMR myocardial tissue phenotyping as a predictor of response to MVr and TEER.
- To construct functional pre-operative CMR fingerprints that recapitulate the mechanical state of the heart to develop individualized computational models, which will be altered in silico based on the proposed treatment plan, to predict patients' response to therapy. These results will be validated against post-operative outcome data to test the validity of this approach for predicting treatment response.
- To explore the relationships among gene products, structural variables, and post-operative clinical outcomes, including reverse remodeling, using tissue obtained at surgery from ventricular myocardium.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitral valve repair | Active comparator | Procedure: Cardiac Magnetic Resonance Imaging, Device: ZioPatch Monitoring, Procedure: Myocardial Tissue BiopsyMitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. |
| Transcatheter edge-to-edge repair | Active comparator | Procedure: Cardiac Magnetic Resonance Imaging, Device: ZioPatch MonitoringPatients will be treated with a commercially-approved edge-to-edge mitral repair device. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.
- For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.
Key exclusion criteria (4 listed)
- Severe claustrophobia not controlled with sedation.
- Prior adverse reaction to gadolinium administration.
- Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.
- Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).
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 |
|---|---|---|
| Cardiac Magnetic Resonance ImagingAlso: CMRNon-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation. | Procedure or surgery | Mitral valve repair, Transcatheter edge-to-edge repair |
| ZioPatch MonitoringAlso: iRhythm MonitoringZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment. | Device | Mitral valve repair, Transcatheter edge-to-edge repair |
| Myocardial Tissue BiopsyAlso: Heart BioplsyDuring the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur. | Procedure or surgery | Mitral valve repair |
Primary outcome
Presence of Myocardial Fibrosis
Time frame: 1 year post index procedure.
Myocardial fibrosis is the buildup of excess fibrous connective tissue in the heart muscle often resulting from chronic injury or stress. It can impair the heart's ability to contract and relax properly leading to reduced cardiac function.
Presence of Ventricular Arrythmia
Time frame: 1 year post index procedure.
A ventricular arrhythmia is an abnormal heart rhythm that starts in the lower chambers of the heart (the ventricles). It can cause the heart to beat too fast, which may reduce blood flow to the body and, in some cases, be life-threatening.
Proteomics
Time frame: 1 year post index procedure.
Proteomics is the large-scale study of proteins, which are essential molecules that carry out most functions in the body. By analyzing proteins in tissues or fluids, scientists can better understand diseases, identify biomarkers, and discover new treatment targets.
1 secondary outcome
Computational and Predictive Models of Treatment Outcome
Time frame: 1 year post index procedure.
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 8 Sep 2026.
- PRIMARY TrialLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data shared will be in aggregate.
Related trials for Mitral Valve Prolapse
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Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
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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.
Joanna Chikwe, MD study director
Cedars-Sinai
Martin Leon, MD study director
Columbia University
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring and Myocardial Tissue Biopsy in people with Mitral Valve Prolapse and Left Ventricular Fibrosis, run by Annetine Gelijns at 25 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, 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?
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?
Presence of Myocardial Fibrosis (time frame: 1 year post index procedure.). The study lists 3 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 8 Sep 2026.