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Percutaneous or Surgical Mitral Valve Repair (PRIMARY)

Primary Purpose

Mitral Valve Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitral valve repair
Transcatheter edge-to-edge repair
Sponsored by
Annetine Gelijns
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Regurgitation focused on measuring surgical mitral valve repair, transcatheter edge-to-edge repair

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity.

Inclusion Criteria:

  • 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
  • Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on the local heart team assessment (see 2020 ACC/AHA guidelines for the management of patients with valvular heart disease)
  • Patients with AF who meet an indication for concomitant ablation may be included provided the local heart team verifies they are eligible for both catheter-based and surgical ablation.
  • Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument

Exclusion Criteria:

  • Other forms of primary MR (e.g., cleft leaflet, endocarditis)
  • Secondary or functional MR
  • Hypertrophic obstructive cardiomyopathy
  • Presence of an IVC filter or pacing/ICD leads that would interfere with TEER per local heart team assessment
  • Known allergic reactions to intravenous contrast
  • Febrile illness within 30-days prior to randomization
  • Any absolute contraindication to transesophageal echocardiography
  • Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia
  • Any prior MV intervention or any prior repair of atrial septal defect
  • Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery
  • Patients with CAD requiring revascularization
  • Need for any emergency intervention or surgery
  • Active endocarditis
  • Hemodynamic instability defined as cardiac index <2.0 l/min/m2 or systolic blood pressure <90mmHg or need for inotropic support or any mechanical circulatory support
  • Left ventricular ejection fraction <25%
  • Intracardiac mass or thrombus
  • Co-morbid medical or oncologic condition for which local heart team believes that meaningful survival beyond 2 years is unlikely
  • Current substance abuse disorder
  • Suspected inability to adhere to follow-up
  • Treatment with another investigational drug or other intervention, assessment of which has not completed its primary endpoint or that clinically interferes with the present study endpoints.

Sites / Locations

  • Keck Hospital of the University of Southern CaliforniaRecruiting
  • Cedars Sinai Medical CenterRecruiting
  • University of California San FranciscoRecruiting
  • Stanford UniversityRecruiting
  • Piedmont Heart InstituteRecruiting
  • Emory UniversityRecruiting
  • Ochsner ClinicRecruiting
  • Maine Medical CenterRecruiting
  • The Johns Hopkins HospitalRecruiting
  • Massachusetts General HospitalRecruiting
  • Brigham and Women'sRecruiting
  • University of Michigan HospitalRecruiting
  • Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung SurgeonsRecruiting
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Nyph/CumcRecruiting
  • Weill Cornell Medicine/ New York-Presbyterian HospitalRecruiting
  • Northwell HealthRecruiting
  • Duke University HospitalRecruiting
  • Cleveland ClinicRecruiting
  • Hospital of the University of PennsylvaniaRecruiting
  • Medical University of South CarolinaRecruiting
  • Baylor, Scott and WhiteRecruiting
  • University of Virginia Medical CenterRecruiting
  • West Virginia University HospitalRecruiting
  • London Health Sciences
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)Recruiting
  • Deutsches Herzzentrum der CharitéRecruiting
  • South Tees Hospitals NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical mitral valve repair

Transcatheter edge-to-edge repair

Arm Description

Patients who are randomized to the surgical arm will undergo mitral surgery.

In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.

Outcomes

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.
Composite score of all-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum follow-up of 3 years post randomization (including a one-month post intervention blanking period for HF hospitalizations/urgent visits). Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean.

Secondary Outcome Measures

Adequacy of MR correction
Adequacy of MR correction at one year post intervention, defined as < 2+ MR as assessed by TTE
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Disease-specific quality of life as measured by the KCCQ at 6-month time intervals up to 5 years. KCCQ has 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score. All scores are scaled 0 to 100, with higher scores indicating better health outcome.
Procedure failure
Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
Procedure failure
Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
All-cause mortality
All-cause mortality through 5 years post randomization
All-cause mortality
All-cause mortality from randomization through 10 years post intervention
Cardiovascular and non-cardiovascular mortality
Cardiovascular and non-cardiovascular mortality from randomization through 5 years post intervention
Cardiovascular and non-cardiovascular mortality
Cardiovascular and non-cardiovascular mortality from randomization through 10 years post intervention
Valve re-interventions
Valve re-interventions through 5 years post intervention
Valve re-interventions
Valve re-interventions through 10 years post intervention
Serious or protocol-defined adverse events
Serious or protocol-defined adverse events, including stroke, acute kidney injury (AKI), and renal failure, through 5 years
MR grade
Mitral Regurgitation (MR) grade as mild, moderate, or severe. (grade I-IV, with higher grade indicating poorer health outcomes.)
Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction.
Left Ventricular End Diastolic Dimension (LVEDD)
Left ventricular end diastolic dimension (LVEDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
Left Ventricular End Systolic Dimension (LVESD)
Left ventricular end systolic dimension (LVESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
Left Ventricular End Diastolic Volume (LVEDV)
Left Ventricular end diastolic volume (LVEDV) is the volume of blood in the left ventricle at the end of the diastole or ventricular filling.
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular end systolic volume (LVESV) is the volume of blood in the left ventricle at the end of the systolic ejection phase immediately before the beginning of diastole or ventricular filling.
Mitral valve gradient
The valve gradient is the difference in pressure on each side of the valve. When a valve is narrowed (a condition called stenosis), the pressure on the front of the valve builds up as blood is forced through the narrow opening. This causes a larger pressure difference between the front and back of the valve. The valve gradient can be used to determine the severity of the valve disorder.
Forward stroke volume
The forward stroke volume is the volume entering the aorta.
6 Minute Walk Test (6MWT)
Functional status as measured by the 6MWT at yearly time intervals over 5 years. 6MT - The distance covered over a time of 6 minutes
EuroQol- 5 Dimension (EQ-5D)
Generic QoL as measured by the EuroQol-5D (EQ-5D). The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Length of stay (LOS)
Length of stay as measured by number of days hospitalized.
ICU days of index hospitalization
Number of ICU days of index hospitalization
Number and reasons for readmissions
Number and reasons for readmissions, including for valve re-intervention and readmissions/urgent visits for heart failure
Cost
Costs associated with the index hospitalization as well as follow-up readmissions will be measured.
Cost-effectiveness
A cost-effectiveness analysis (CEA) comparing cumulative costs and quality-adjusted life years (QALYs) of transcatheter edge-to-edge repair vs surgical repair will be performed from U.S., Canadian, German and United Kingdom health care sector perspectives according to national guidelines.

Full Information

First Posted
September 10, 2021
Last Updated
July 10, 2023
Sponsor
Annetine Gelijns
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05051033
Brief Title
Percutaneous or Surgical Mitral Valve Repair
Acronym
PRIMARY
Official Title
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
January 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Annetine Gelijns
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
Detailed Description
The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER compared with surgical repair in patients with primary, degenerative MR. The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations/urgent care visits, valve re-interventions, and quality of life). The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation. The patient population for this trial consists of adult patients with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Because the use of the commercial edge-to-edge mitral repair device in the U.S. is approved only in patients considered to be at prohibitive risk of MV surgery by a heart team, use of such devices in this trial is considered investigational by the FDA. As such, this trial will be conducted under an Investigational Device Exemption (IDE ). Outcomes will be measured from randomization over a period of 5 years post intervention. The estimated enrollment period is 36 months, and all patients will be followed from randomization for up to 10 years post intervention for particular endpoints. Long-term follow-up will include leveraging administrative datasets linked to clinical trial data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
Keywords
surgical mitral valve repair, transcatheter edge-to-edge repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible and consented patients will be randomized 1:1 to a TEER versus surgical repair. Patient randomization will be stratified by clinical site and by surgical risk profile, namely low, intermediate, and high surgical risk. Primary effectiveness will be analyzed by intention-to-treat; that is, the patients will be grouped by their assignment at randomization whether or not they actually received the treatment to which they were assigned.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical mitral valve repair
Arm Type
Active Comparator
Arm Description
Patients who are randomized to the surgical arm will undergo mitral surgery.
Arm Title
Transcatheter edge-to-edge repair
Arm Type
Active Comparator
Arm Description
In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Intervention Type
Procedure
Intervention Name(s)
Mitral valve repair
Other Intervention Name(s)
Mitral valve surgery
Intervention Description
Patients who are randomized to the surgical arm will undergo mitral surgery. 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. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.
Intervention Type
Device
Intervention Name(s)
Transcatheter edge-to-edge repair
Other Intervention Name(s)
TEER
Intervention Description
Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.
Primary Outcome Measure Information:
Title
All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) composite score.
Description
Composite score of all-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum follow-up of 3 years post randomization (including a one-month post intervention blanking period for HF hospitalizations/urgent visits). Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean.
Time Frame
3 years post intervention
Secondary Outcome Measure Information:
Title
Adequacy of MR correction
Description
Adequacy of MR correction at one year post intervention, defined as < 2+ MR as assessed by TTE
Time Frame
one year post intervention
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
Disease-specific quality of life as measured by the KCCQ at 6-month time intervals up to 5 years. KCCQ has 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score. All scores are scaled 0 to 100, with higher scores indicating better health outcome.
Time Frame
up to 10 years post intervention
Title
Procedure failure
Description
Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
Time Frame
End of procedure
Title
Procedure failure
Description
Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
Time Frame
10 years post randomization
Title
All-cause mortality
Description
All-cause mortality through 5 years post randomization
Time Frame
5 years post randomization
Title
All-cause mortality
Description
All-cause mortality from randomization through 10 years post intervention
Time Frame
10 years post intervention
Title
Cardiovascular and non-cardiovascular mortality
Description
Cardiovascular and non-cardiovascular mortality from randomization through 5 years post intervention
Time Frame
5 years post intervention
Title
Cardiovascular and non-cardiovascular mortality
Description
Cardiovascular and non-cardiovascular mortality from randomization through 10 years post intervention
Time Frame
10 years post intervention
Title
Valve re-interventions
Description
Valve re-interventions through 5 years post intervention
Time Frame
5 years post intervention
Title
Valve re-interventions
Description
Valve re-interventions through 10 years post intervention
Time Frame
10 years post intervention
Title
Serious or protocol-defined adverse events
Description
Serious or protocol-defined adverse events, including stroke, acute kidney injury (AKI), and renal failure, through 5 years
Time Frame
5 years post intervention
Title
MR grade
Description
Mitral Regurgitation (MR) grade as mild, moderate, or severe. (grade I-IV, with higher grade indicating poorer health outcomes.)
Time Frame
through 5 years post intervention
Title
Left Ventricular Ejection Fraction (LVEF)
Description
Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction.
Time Frame
through 5 years post intervention
Title
Left Ventricular End Diastolic Dimension (LVEDD)
Description
Left ventricular end diastolic dimension (LVEDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
Time Frame
through 5 years post intervention
Title
Left Ventricular End Systolic Dimension (LVESD)
Description
Left ventricular end systolic dimension (LVESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
Time Frame
through 5 years post intervention
Title
Left Ventricular End Diastolic Volume (LVEDV)
Description
Left Ventricular end diastolic volume (LVEDV) is the volume of blood in the left ventricle at the end of the diastole or ventricular filling.
Time Frame
through 5 years post intervention
Title
Left Ventricular End Systolic Volume (LVESV)
Description
Left Ventricular end systolic volume (LVESV) is the volume of blood in the left ventricle at the end of the systolic ejection phase immediately before the beginning of diastole or ventricular filling.
Time Frame
through 5 years post intervention
Title
Mitral valve gradient
Description
The valve gradient is the difference in pressure on each side of the valve. When a valve is narrowed (a condition called stenosis), the pressure on the front of the valve builds up as blood is forced through the narrow opening. This causes a larger pressure difference between the front and back of the valve. The valve gradient can be used to determine the severity of the valve disorder.
Time Frame
through 5 years post intervention
Title
Forward stroke volume
Description
The forward stroke volume is the volume entering the aorta.
Time Frame
through 5 years post intervention
Title
6 Minute Walk Test (6MWT)
Description
Functional status as measured by the 6MWT at yearly time intervals over 5 years. 6MT - The distance covered over a time of 6 minutes
Time Frame
through 5 years post intervention
Title
EuroQol- 5 Dimension (EQ-5D)
Description
Generic QoL as measured by the EuroQol-5D (EQ-5D). The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Time Frame
through 10 years post intervention
Title
Length of stay (LOS)
Description
Length of stay as measured by number of days hospitalized.
Time Frame
through 10 years post intervention
Title
ICU days of index hospitalization
Description
Number of ICU days of index hospitalization
Time Frame
through 10 years post intervention
Title
Number and reasons for readmissions
Description
Number and reasons for readmissions, including for valve re-intervention and readmissions/urgent visits for heart failure
Time Frame
through 10 years post intervention
Title
Cost
Description
Costs associated with the index hospitalization as well as follow-up readmissions will be measured.
Time Frame
through 10 years post intervention
Title
Cost-effectiveness
Description
A cost-effectiveness analysis (CEA) comparing cumulative costs and quality-adjusted life years (QALYs) of transcatheter edge-to-edge repair vs surgical repair will be performed from U.S., Canadian, German and United Kingdom health care sector perspectives according to national guidelines.
Time Frame
through 10 years post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity. Inclusion Criteria: 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 Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on the local heart team assessment (see 2020 ACC/AHA guidelines for the management of patients with valvular heart disease) Patients with AF who meet an indication for concomitant ablation may be included provided the local heart team verifies they are eligible for both catheter-based and surgical ablation. Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument Exclusion Criteria: Non-degenerative types of primary MR (e.g., cleft leaflet) Secondary or functional MR Hypertrophic obstructive cardiomyopathy Presence of an IVC filter or pacing/ICD leads that would interfere with TEER per local heart team assessment Known allergic reactions to intravenous contrast Febrile illness within 30-days prior to randomization Any absolute contraindication to transesophageal echocardiography Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia Patients with CAD requiring revascularization Any prior mitral valve intervention or any prior repair of atrial septal defect Any prior MV intervention or any prior repair of atrial septal defect Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery Need for any emergency intervention or surgery Active endocarditis Hemodynamic instability defined as cardiac index <2.0 l/min/m2 or systolic blood pressure <90mmHg or need for inotropic support or any mechanical circulatory support Left ventricular ejection fraction <25% Intracardiac mass or thrombus Co-morbid medical or oncologic condition for which local heart team believes that meaningful survival beyond 2 years is unlikely Active substance abuse Suspected inability to adhere to follow-up Treatment with another investigational drug or other intervention, assessment of which has not completed its primary endpoint or that clinically interferes with the present study endpoints.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chari Ponder, RN, BSN
Phone
(646) 899-8106
Email
chari.ponder@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Moquete, RN
Phone
646-734-7229
Email
ellen.moquete@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joann Chikwe, MD
Organizational Affiliation
Cedars Sinai
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martin Leon, MD
Organizational Affiliation
Columbia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Patrick O'Gara, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Keck Hospital of the University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Lozano
Email
edwardlo@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Vaughn Starnes, MD
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achille Peiris
Email
Achille.Peiris@cshs.org
First Name & Middle Initial & Last Name & Degree
Joanna Chikwe
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Liu
Email
Donna.Liu@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Tom Nguyen, MD
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luz Memije
Email
memije16@stanford.edu
First Name & Middle Initial & Last Name & Degree
Jack Boyd, MD
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akimi Rhodes
Email
Akimi.Rhodes@piedmont.org
First Name & Middle Initial & Last Name & Degree
Vinod Thourani, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Matheson
Email
sbmathe@emory.edu
First Name & Middle Initial & Last Name & Degree
Michael Halkos, MD
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Scholl
Email
Nicolle.scholl@ochsner.org
First Name & Middle Initial & Last Name & Degree
E. Patrick Parrino, MD
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Betsey Gallant
Email
Betsey.Gallant@mainehealth.org
First Name & Middle Initial & Last Name & Degree
Robert Kramer, MD
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Fornaresio, PhD
Email
lisa.fornaresio@jhmi.edu
First Name & Middle Initial & Last Name & Degree
James Gammie, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Ramsay
Email
agramsay@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Serguei Melnitchouk, MD
Facility Name
Brigham and Women's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Ramsay
Email
AGRAMSAY@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Mark Cunningham, MD
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
China Green
Email
chjgreen@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Gorav Ailawadi
Facility Name
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Peterman, RN, BSN, CCRC
Email
Dpeterman@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Keith Allen, MD
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prezley Duncan, MS
Email
Prezley.M.Duncan@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Jock McCullough, MD
Facility Name
Nyph/Cumc
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olutobi Adewale
Email
oa2386@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Isaac George
Facility Name
Weill Cornell Medicine/ New York-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marshagay Rodrigues
Email
mar4028@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Stephanie Mick, MD
Facility Name
Northwell Health
City
New York
State/Province
New York
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efstathia (Effe) Mihelis, PA-C, MBA
Email
emihelis@northwell.edu
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Lane
Email
kathleen.rohrback@duke.edu
First Name & Middle Initial & Last Name & Degree
Donlad Glower, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanell Hill, MSN, RN, CNE
Email
HILLS@ccf.org
First Name & Middle Initial & Last Name & Degree
Anna M Simmons
Email
SIMMONA8@ccf.org
First Name & Middle Initial & Last Name & Degree
Marc Gillinov
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Lou Mayer, RN, BSN
Email
MaryLou.Mayer@pennmedicine.upenn.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Katz, MD
Facility Name
Baylor, Scott and White
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Kennedy
Email
Jasmine.Kennedy@BSWHealth.org
First Name & Middle Initial & Last Name & Degree
Molly Szerlip, MD
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Sprouse
Email
NJB6M@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Linda Bryceland
Email
lgs2m@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Scott Lim
First Name & Middle Initial & Last Name & Degree
Kenan Yount
Facility Name
West Virginia University Hospital
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josh Bombard
Email
josh.bombard@wvumedicine.org
First Name & Middle Initial & Last Name & Degree
Vinay Badhwar
Facility Name
London Health Sciences
City
London
State/Province
Ontario
ZIP/Postal Code
ON N6A 5W9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
QC G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Bergeron
Email
annie.bergeron@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Pierre Voisine
Facility Name
Deutsches Herzzentrum der Charité
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volkmar Falk
Facility Name
South Tees Hospitals NHS Foundation Trust
City
Middlesbrough
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arran Morgan
Email
arra.morgan@nhs.net
First Name & Middle Initial & Last Name & Degree
Enoch Akowuah

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.
IPD Sharing Access Criteria
Anyone who wishes to access the data. Any purpose. Data are available indefinitely at link included in the URL field below.
IPD Sharing URL
https://biolincc.nhlbi.nih.gov/studies/

Learn more about this trial

Percutaneous or Surgical Mitral Valve Repair

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