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Percutaneous vs Surgical Repair for Mitral Valve Regurgitation (PRIMARY Trial)
N/A
Recruiting
Research Sponsored by Annetine Gelijns
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients ≥65 yrs with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography
Clinical indication for MV intervention and anatomic candidate for both MV transcatheter edge-to-edge and surgical repair per local heart team assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year post intervention
Awards & highlights
PRIMARY Trial Summary
This trial will compare two methods for repairing a damaged mitral valve in people with primary, degenerative mitral regurgitation. One method is called mitral valve transcatheter edge-to-edge repair, and the other is surgical repair. The trial will be conducted in the U.S., Canada, Germany and the United Kingdom.
Who is the study for?
This trial is for adults aged 65 or older with a specific heart valve condition called primary degenerative mitral regurgitation. Candidates must be able to perform physical tests and complete health questionnaires, and are eligible across all surgical risk levels. Exclusions include recent febrile illness, need for other heart surgeries, certain allergic reactions, bleeding disorders, prior mitral interventions, and severe co-existing conditions.Check my eligibility
What is being tested?
The PRIMARY trial compares two treatments for mitral valve prolapse: a less invasive procedure called transcatheter edge-to-edge repair (TEER) versus traditional surgery. Participants will be randomly assigned to one of the two options in equal numbers at multiple centers internationally.See study design
What are the potential side effects?
Potential side effects may vary between procedures but can include bleeding, infection risks associated with any heart procedure, possible allergic reactions to materials used during TEER or anesthesia complications from surgery.
PRIMARY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 65 or older with severe valve leakage as shown by an echo test.
Select...
I am a candidate for a specific heart valve repair procedure as assessed by my heart care team.
Select...
I can walk for 6 minutes and fill out a heart disease questionnaire.
PRIMARY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) composite score.
Secondary outcome measures
6 Minute Walk Test (6MWT)
Adequacy of MR correction
All-cause mortality
+19 morePRIMARY Trial Design
2Treatment groups
Active Control
Group I: Surgical mitral valve repairActive Control1 Intervention
Patients who are randomized to the surgical arm will undergo mitral surgery.
Group II: Transcatheter edge-to-edge repairActive Control1 Intervention
In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.
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Who is running the clinical trial?
Annetine GelijnsLead Sponsor
2 Previous Clinical Trials
419 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,598 Total Patients Enrolled
Joann Chikwe, MDStudy DirectorCedars Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You might not be able to keep up with the required check-ups and appointments.I have a thickened heart muscle that obstructs blood flow.You have secondary or functional mitral regurgitation.You are allergic to the contrast dye used for intravenous injections.I need surgery on my heart valves or aorta.My heart valve issue is not due to wear and tear.I have an active infection in my heart's lining.You have a medical reason that makes it unsafe for you to have a transesophageal echocardiography.I do not have conditions that prevent me from using blood thinners.Your heart's pumping ability is less than 25%.I need a procedure to improve blood flow to my heart.You have had a surgery to fix a problem with your mitral valve or a hole in your heart called an atrial septal defect.I need emergency surgery or intervention.If you have atrial fibrillation and need both catheter-based and surgical ablation, your local heart team must confirm that you are eligible for both procedures.I have a mass or clot inside my heart.I do not have severe heart issues like very low blood pressure or need for heart support devices.You have another serious medical condition that the local heart team thinks will make it unlikely for you to live more than 2 years.I am 65 or older with severe valve leakage as shown by an echo test.My heart condition is considered low, intermediate, or high risk by my medical team.I am a candidate for a specific heart valve repair procedure as assessed by my heart care team.I can walk for 6 minutes and fill out a heart disease questionnaire.I have not had a fever or flu-like illness in the last 30 days.You have a device in your heart that could cause problems with the study, as determined by your local heart team.You are currently using drugs or alcohol excessively.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical mitral valve repair
- Group 2: Transcatheter edge-to-edge repair
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you enumerate the locations in which this experiment is conducted within the United States?
"This trial is accessible in 30 different medical centres, including The Johns Hopkins Hospital (Baltimore), Massachusetts General Hospital (Boston), and Medical University of South carolina (Charleston). Additional participating sites are scattered around the United States."
Answered by AI
Are participants being accepted into the trial at this time?
"Clinicaltrials.gov states that this experiment is presently searching for participants; it was first announced on January 14th of 2022 and last updated on October 26th."
Answered by AI
What is the aggregate amount of subjects participating in this investigation?
"Affirmative. Data from clinicaltrials.gov reveals that this medical trial is presently enrolling patients, with the initial posting on January 14th 2022 and most recent update made on October 26th 2022. 450 individuals need to be recruited at 30 different research sites."
Answered by AI
Who else is applying?
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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