Clinical Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients (COAPT)
This study is currently recruiting participants.
Verified October 2013 by Evalve
Information provided by (Responsible Party):
First received: June 20, 2012
Last updated: October 16, 2013
Last verified: October 2013
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.
Mitral Valve Regurgitation
Device: MitraClip System
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk Patients
Primary Outcome Measures:
- Primary safety endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Composite of death (all-cause), stroke, worsening kidney dysfunction, permanent left ventricular assist device (LVAD) implant, or heart transplant
- Primary effectiveness endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Recurrent heart failure (HF) hospitalizations
Secondary Outcome Measures:
- Composite 30 day secondary safety endpoint [ Time Frame: 30 days post-procedure in the Device group ] [ Designated as safety issue: Yes ]
Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications
- Mitral Regurgitation severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Change in distance walked on the 6 Minute Walk Test (6MWT distance or 6MWD) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
- Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
- Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
- New York Heart Association (NYHA) Functional Class I/II [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Recurrent hospitalizations - all cause [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- All-cause mortality at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Freedom from all-cause mortality at 12 months will be a secondary measure of safety
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2017 (Final data collection date for primary outcome measure)
Experimental: Percutaneous mitral valve repair using MitraClip System
Device: MitraClip System
Percutaneous mitral valve repair using MitraClip System
- MitraClip device
No Intervention: Control Group
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a transthoracic echocardiogram (TTE)obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to enrollment, with MR severity confirmed by the Echocardiography Core Lab.
- In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or optimal therapy as appropriate
- New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
- The subject is extremely high risk for open mitral valve surgery due to comorbidities such that the calculated Society of Thoracic Surgeons (STS) mortality risk is ≥ 8%, or the Local Site Heart Team concludes that comorbidities result in extremely high operative risk of stroke or death. A candidate who does not meet the STS mortality risk criterion of ≥ 8% can be included in the trial if the Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur and document that the subject has extremely high operative risk of stroke or death from open mitral valve surgery for reasons not captured by the STS risk calculator. The local site surgeon's assessment of operative comorbidities not captured by the STS risk calculator must be documented in the case report form as well as in the subject's medical record.
- The subject has had at least one hospitalization for heart failure in the 12 months prior to enrollment and/or B-type natriuretic peptide (BNP) ≥400 pg/ml or N-terminal fragment pro B-type natriuretic peptide (NT-proBNP) ≥1600 pg/ml measured within 90 days prior to enrollment.
- 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.
- Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN)
- Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
- Age 18 years or older.
- The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be enrolled in this trial.
- 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.
- The subject has severe LV dysfunction based on a transthoracic echocardiogram(TTE) obtained within 60 days prior to enrollment (severe LV dysfunction is defined as Left Ventricular End Systolic Dimension (LVESD) >60mm or Left Ventricular Ejection Fraction (LVEF) <20%) and confirmed by the Echocardiography Core Laboratory.
- Evidence of an acute myocardial infarction within 30 days prior to enrollment.
- Untreated clinically significant coronary artery disease requiring revascularization or tricuspid or aortic valve disease requiring surgery.
- Cerebrovascular accident within 6 months prior to enrollment or severe symptomatic carotid stenosis (> 70% by ultrasound).
- American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure.
Presence of any of the following:
- Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by echocardiography or right heart catheterization
- 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
- Severe right ventricular failure identified by severely reduced/poor wall motion or severe tricuspid regurgitation.
- Any percutaneous cardiac intervention or carotid surgery within 30 days prior to enrollment, or any cardiac surgery within 6 months prior to enrollment.
- 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 prior to enrollment, or revision of any implanted rhythm management device within last 90 days prior to enrollment.
- Mitral valve orifice area < 4.0 cm2 based on a transthoracic echocardiogram (TTE)within 60 days prior to enrollment, and confirmed by the Echocardiography Core Laboratory.
- If leaflet tethering is present, vertical coaptation length is less than 2 mm based on a transesophageal echocardiogram (TEE) within 180 days prior to enrollment.
Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR. This include, but are not limited to:
- Evidence of calcification in the grasping area
- Presence of a significant cleft in the grasping area
- Lack of both primary and secondary chordal support in the grasping area
- Leaflet mobility length < 1 cm
- Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
- 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 disability.
- Status 1 heart transplant or prior orthotopic heart transplantation.
- Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
- Active infections requiring current antibiotic therapy.
- Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
- Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
- Pregnant or planning pregnancy within next 12 months.
- Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626079
||Abbott Vascular Structural Heart (Evalve Inc)
||Michael Mack, MD
||Baylor Health Care System
||Gregg Stone, MD
||Columbia University Medical Center / New York-Presbyterian Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 20, 2012
||October 16, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Mitral Valve Insufficiency
Heart Valve Diseases