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History of Changes for Study: NCT01626079
Clinical Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients (COAPT)
Latest version (submitted January 6, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 21, 2012 None (earliest Version on record)
2 August 1, 2012 Contacts/Locations and Study Status
3 August 9, 2012 Outcome Measures and Study Status
4 October 12, 2012 Contacts/Locations and Study Status
5 December 13, 2012 Recruitment Status, Study Status and Contacts/Locations
6 December 19, 2012 Contacts/Locations and Study Status
7 January 2, 2013 Study Status and Contacts/Locations
8 January 23, 2013 Contacts/Locations and Study Status
9 January 30, 2013 Contacts/Locations and Study Status
10 February 4, 2013 Study Status and Contacts/Locations
11 February 26, 2013 Contacts/Locations and Study Status
12 March 7, 2013 Study Status, Contacts/Locations, Eligibility and Study Design
13 June 3, 2013 Outcome Measures, Study Status and Eligibility
14 July 22, 2013 Outcome Measures, Eligibility and Study Status
15 October 14, 2013 Contacts/Locations, Study Status, Eligibility and Outcome Measures
16 October 16, 2013 Contacts/Locations and Study Status
17 January 14, 2014 Study Status, Outcome Measures, Study Description, Study Identification, References, Eligibility, Study Design and Oversight
18 January 29, 2014 Contacts/Locations and Study Status
19 March 5, 2014 Contacts/Locations and Study Status
20 October 24, 2014 Contacts/Locations, Study Status, Eligibility and Study Identification
21 December 16, 2014 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Status, Eligibility, Conditions and Study Description
22 March 11, 2015 Contacts/Locations, Study Description, Study Status, Eligibility, Outcome Measures and Conditions
23 April 23, 2015 Study Status and Contacts/Locations
24 June 3, 2015 Contacts/Locations and Study Status
25 October 9, 2015 Contacts/Locations and Study Status
26 February 10, 2016 Study Status and Contacts/Locations
27 June 6, 2016 Contacts/Locations, Study Status, Study Design and Study Description
28 January 31, 2017 Contacts/Locations, Outcome Measures, Study Description, Study Status, Study Identification, Eligibility and Study Design
29 July 14, 2017 Contacts/Locations, Study Status, Outcome Measures, Conditions, Study Description, References, Eligibility and Study Design
30 November 6, 2017 Contacts/Locations and Study Status
31 December 1, 2017 Study Status and Contacts/Locations
32 May 30, 2018 Contacts/Locations, Study Status, Outcome Measures and Study Description
33 September 10, 2018 Study Status, Study Description and Study Identification
34 November 5, 2018 Study Status and Study Identification
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Results Submission Events
35 April 26, 2020 Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Study Design, Study Description, Documents, Results and Study Identification
36 January 6, 2021 Study Status
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Study NCT01626079
Submitted Date:  March 7, 2013 (v12)

Open or close this module Study Identification
Unique Protocol ID: 11-512
Brief Title: Clinical Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients (COAPT)
Official Title: Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2013
Overall Status: Recruiting
Study Start: August 2012
Primary Completion: January 2017 [Anticipated]
Study Completion: August 2019 [Anticipated]
First Submitted: June 20, 2012
First Submitted that
Met QC Criteria:
June 21, 2012
First Posted: June 22, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 7, 2013
Last Update Posted: March 8, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Abbott Medical Devices
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary: The purpose of the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in high surgical risk subjects.
Detailed Description:
Open or close this module Conditions
Conditions: Mitral Regurgitation
Mitral Valve Regurgitation
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 420 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Percutaneous mitral valve repair using MitraClip System Device: MitraClip System
Percutaneous mitral valve repair using MitraClip System
Other Names:
  • MitraClip device
  • MitraClip
No Intervention: Control Group
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Primary safety endpoint
Composite of death (all-cause), stroke (major and minor), new onset or worsening of kidney dysfunction resulting in Stage 2 or 3 classification, left ventricular assist device (LVAD) implant, and heart transplant

[Time Frame: 12 months]
2. Primary Effectiveness Endpoint
Recurrent heart failure (HF) hospitalizations

[Time Frame: 12 months]
Secondary Outcome Measures:
3. Composite 30 day secondary safety endpoint
Composite of death (all-cause), stroke (major and minor), myocardial infarction (MI), and non-elective cardiovascular surgery for device related complications

[Time Frame: 30 days post-procedure in the Device group]
4. Mitral Regurgitation severity of 2+ or less
12 months
5. Improvement in distance walked on the 6 Minute Walk Test (6MWT)
12 months over baseline
6. Improvement in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
12 months over baseline
7. Improvement in Left Ventricular End Diastolic Volume (LVEDV)
12 months over baseline
8. New York Heart Association (NYHA) Functional Class I/II
12 months
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Symptomatic (NYHA Functional Class II, III or ambulatory IV) functional mitral regurgitation(≥3+) determined by assessment of a TTE obtained within the prior 6 months of enrollment and mitral regurgitation severity is confirmed by the Echocardiography Core Lab
  • Subject must have comorbidities such that a CT surgeon investigator at the site determines that medical factors preclude surgery based on a conclusion that the probability of death or serious morbidity, exceeds the probability of meaningful improvement and this conclusion is confirmed by the Eligibility Committee.
  • In the judgment of an experienced cardiologist investigator at the site, the subject is likely to benefit from mitral regurgitation reduction, and this conclusion is confirmed by the Eligibility Committee
  • The subject has been adequately treated per applicable standards, such as for coronary artery disease left ventricular dysfunction, mitral regurgitation or heart failure (e.g., cardiac resynchronization therapy revascularization optimal medical therapy).
  • Left ventricular ejection fraction (LVEF) > 20% and left ventricular end-systolic dimension (LVESD) ≤ 60 mm based on an echocardiogram obtained within the prior 6 months
  • The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve. If a secondary jet exists, it must be considered clinically insignificant.
  • Transseptal catheterization and femoral vein access is determined to be feasible.
  • Age 18 years or older
  • The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent

Exclusion Criteria:

  • Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR)
  • Evidence of an acute myocardial infarction in the prior 90 days (defined as: Q wave or non-Q wave infarction having CK enzymes ≥ 2X the upper laboratory normal limit with the presence of a CK-MB elevated above the institution's upper limit of normal)
  • Untreated clinically significant coronary artery disease requiring revascularization.
  • Cerebrovascular accident within 6 months prior to randomization or severe carotid stenosis (> 70% by ultrasound)
  • ACC/AHA Stage D heart failure
  • Presence of any of the following:
  • Severe TR or AR or moderate to severe AS (< 1.0 cm2)
  • Estimated pulmonary artery systolic pressure (PASP) > 60 mm Hg assessed by echocardiography
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
  • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
  • Hemodynamic instability requiring inotropic support or mechanical heart assistance
  • Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within the 6 months prior to randomization.
  • Implant of any rhythm management device (i.e., pacemaker, Cardiac Resynchronization Therapy (CRT) Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD)) within the last 90 days or revision of any implanted rhythm management device within the last 90 days
  • Mitral valve orifice area < 4.0 cm2
  • If leaflet tethering is present, vertical coaptation length is less than 2 mm.
  • Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in mitral regurgitation. This may include:
  • Evidence of calcification in the grasping area of the A2 and/or P2 scallops
  • Presence of a significant cleft of A2 or P2 scallops
  • Lack of both primary and secondary chordal support
  • Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction cardiogenic shock or the need for inotropic support or intra-aortic balloon pump
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  • Life expectancy < 12 months due to non-cardiac conditions
  • Modified Rankin Scale ≥ 4
  • Status 1 heart transplant or prior orthotopic heart transplantation.
  • Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve.
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  • Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic diseased (i.e., noncompliant, perforated).
  • Active infections requiring current antibiotic therapy.
  • Subjects in whom transesophageal echocardiography (TEE) is contraindicated
  • A known hypersensitivity or contraindication to procedure medications which cannot be adequately managed medically
  • Pregnant or planning pregnancy within next 12 months
  • In the judgment of the Investigator, subjects in whom the presence of a permanent pacemaker or pacing leads would interfere with placement of the MitraClip device or the placement of the MitraClip device would disrupt the leads
  • Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational trials
Open or close this module Contacts/Locations
Central Contact Person: Barathi Sethuraman
Telephone: 650 833-1638
Email: barathi.sethuraman@av.abbott.com
Study Officials: Barathi Sethuraman
Study Director
Abbott Vascular Structural Heart (Evalve Inc)
Michael Mack, MD
Principal Investigator
Baylor Health Care System
Gregg Stone, MD
Principal Investigator
Columbia University Medical Center / New York-Presbyterian Hospital
Locations: United States, District of Columbia
Washington Hospital Center
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: Kenneth Kent, MD 202-877-5975 kenneth.m.kent@medstar.net
Contact:Principal Investigator: Kenneth Kent, MD
United States, Illinois
Northwestern Memorial Hospital
[Recruiting]
Chicago, Illinois, United States, 60611
Contact:Contact: Patrick McCarthy, MD 312-695-3114 pmccart@nmh.org
Contact:Principal Investigator: Patrick McCarthy, MD
United States, Maine
Maine Medical Center
[Recruiting]
Portland, Maine, United States, 04102
Contact:Contact: Mirle Kellet, Jr, MD 207-662-2414 kellem@mmc.org
Contact:Principal Investigator: Mirle Kellet, Jr, MD
United States, New York
Columbia University Medical Center
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: William Gray, MD 212-305-7060
Contact:Principal Investigator: William Gray, MD
United States, North Carolina
Duke University Hospital
[Recruiting]
Durham, North Carolina, United States, 27710
Contact:Contact: Andrew Wang, MD 919-681-6197 a.wang@duke.edu
Contact:Principal Investigator: Andrew Wang, MD
United States, Oklahoma
Oklahoma Heart Hospital
[Recruiting]
Oklahoma City, Oklahoma, United States, 73120
Contact:Contact: Mohammad Ghani, MD 405-608-3800 mghani@ohkeart.com
Contact:Principal Investigator: Mohammad Ghani, MD
United States, Pennsylvania
University of Pittsburgh Medical Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15213
Contact:Contact: Anson Jay C Smith, M.D. 412-647-8117 smithaj@upmc.edu
Contact:Principal Investigator: Anson Jay C Smith, M.D.
Pinnacle Health at Harrisburg Hospital
[Recruiting]
Wormleysburg, Pennsylvania, United States, 17043
Contact:Contact: Brijeshwar Maini, MD 717-731-0101 bmaini@pinnaclehealth.org
Contact:Principal Investigator: Brijeshwar Maini, MD
United States, Virginia
University of Virginia
[Recruiting]
Charlottesville, Virginia, United States, 22908
Contact:Contact: Scott Lim, MD 434-982-1058 sl9pc@virginia.edu
Contact:Principal Investigator: Scott Lim, MD
United States, Washington
Swedish Medical Center
[Not yet recruiting]
Seattle, Washington, United States, 98122
Contact:Contact: Mark Reisman, MD 206-861-8550
Contact:Principal Investigator: Mark Reisman, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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