PRIMARY Ancillary Substudy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAnnetine Gelijns
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Cardiac Magnetic Resonance Imaging
Procedure/SurgeryNon-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch Monitoring
DeviceZioPatch 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 Biopsy
Procedure/SurgeryDuring 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Mitral valve repairActive comparator 3 interventions
Group B: Transcatheter edge-to-edge repairActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year post index procedure.2
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.
Time frame
1 year post index procedure.3
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.
Time frame
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.
Time frame
1 year post index procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Annetine Gelijns
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov