|September 13, 2005
|September 17, 2013
|November 2009 (Final data collection date for primary outcome measure)
- Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation (MR). [ Time Frame: 12 months ]
- Major adverse events (MAE) [ Time Frame: 30 days ]
defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
- The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 12 months.
- The primary safety endpoint is freedom from major adverse events (MAE) at 30 days.
|Complete list of historical versions of study NCT00209274 on ClinicalTrials.gov Archive Site
- Major adverse events (MAE) [ Time Frame: 12 months. ]
- Major bleeding complications. [ Time Frame: 30 days and 12 months. ]
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital
- Non-cerebral thromboembolism. [ Time Frame: 30 days and 12 months. ]
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
- Endocarditis. [ Time Frame: 30 days and 12 months. ]
Defined as a diagnosis of endocarditis based on the Duke criteria.From The American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Patients with Valvular Heart Disease, Journal of the American College of Cardiology (JACC), Vol 32, No.5,November 1, 1998:pg1541, Table 21
- Thrombosis. [ Time Frame: 30 days and 12 months. ]
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
- Hemolysis. [ Time Frame: 30 days and 12 months. ]
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.
Reported as major or minor as defined below:
Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
- Clinically significant Atrial septal defect (ASD). [ Time Frame: 30 days and 12 months. ]
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
- Mitral Valve stenosis. [ Time Frame: 30 days and 12 months. ]
Defined as a mitral valve planimetered orifice area of less than 1.5 cm2 as measured by echocardiography.
- New York Heart Association (NYHA) functional class cardiac disease. [ Time Frame: 30 days, 6 months and 12 months ]
Class I Patients with cardiac disease but without resulting limitations of physical activity. Class II Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
- Acute procedural success [ Time Frame: 30 Days ]
Defined as successful MitraClip implantation with resulting MR of 2+ or less.
- Post-procedure length of hospital stay. [ Time Frame: 30 Days ]
- Post-procedure intensive care unit (ICU) / critical care unit (CCU)/(post-anesthesia care unit) PACU duration. [ Time Frame: 30 Days ]
- Short Form (SF)-36 Quality of Life questionnaire. [ Time Frame: 30 days and 12 months ]
- MAE in patients over 75 years of age. [ Time Frame: 12 months ]
- Mitral valve repair success. [ Time Frame: 12 months ]
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
- Procedural success [ Time Frame: 30 days ]
Defined as successful implant of the Clip(s) with resulting MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
- Freedom from surgery for valve dysfunction, death, and moderate to severe (3+) or severe (4+) mitral regurgitation. [ Time Frame: 18 and 24 months ]
- Clip implant rate [ Time Frame: Day 0 ]
defined as the rate of successful implantation of MitraClip(s).
- Procedural freedom from MAE. [ Time Frame: Day 0 ]
- Acute surgical success [ Time Frame: 30 Days ]
Defined as successful mitral valve repair or replacement.
- Left Ventricular Status [ Time Frame: 30 days and 12 months ]
Left Ventricular Status is defined a including including Left ventricular (LV) ejection fraction (EF), LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), LV internal dimension systole (LVIDs), and LV internal dimension diastole (LVIDd) as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer, and 12 months.
- Incidence of hospital readmissions for congestive heart failure (CHF). [ Time Frame: 12 months pre- versus post-MitraClip ]
- Number of days hospitalized for CHF. [ Time Frame: 12 months pre- versus post-MitraClip ]
- 6 Minute Walk Test. [ Time Frame: 30 days, 6 months, 12 months ]
- Major vascular [ Time Frame: 30 days and 12 months. ]
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer:
- Hematoma at access site >6 cm.;
- Retroperitoneal hematoma;
- Arteriovenous (AV) fistula;
- Symptomatic peripheral ischemia/ nerve injury or the clinical signs or symptoms lasting >48 hours;
- Vascular Surgical Repair at catheter access sites;
- Pulmonary embolism;
- Ipsilateral deep vein thrombus; or
- Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
- Major vascular and bleeding complications
- Non-cerebral thromboembolism
- Atrial septal defect
- MV stenosis
- NYHA classification
- Acute procedural success
- Post-procedure length of hospital stay
- Quality of Life
- Cardiac output [ Time Frame: 30 days and 12 months ]
Cardiac output as measured by core lab echocardiography
- Cardiac index [ Time Frame: 30 days and 12 months ]
Defined as cardiac index (cardiac output divided by body surface area) as measured by core lab echocardiography
- Incidence of new Coumadin (warfarin) usage [ Time Frame: 30 days and 6 months ]
- Incidence of discharge to a nursing home or skilled nursing facility. [ Time Frame: 30 Days ]
- Mitral valve index [ Time Frame: 30 Days ]
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
- Mitral valve area [ Time Frame: 30 Days ]
Defined as mitral valve area as measured by core lab echocardiography.
- Transvalvular flow gradient [ Time Frame: 30 Days ]
Peak and Mean
- Regurgitant volume [ Time Frame: 30 Days ]
Regurgitant volume as determined by the core echo laboratory.
- Regurgitant fraction [ Time Frame: 30 Days ]
Regurgitant fraction as determined by the core echo laboratory.
- Incidence of mitral valve replacement [ Time Frame: 30 Days and 12 months ]
- Hospital re-admissions [ Time Frame: 30 Days and 12 months ]
|Pivotal Study of a Percutaneous Mitral Valve Repair System
|Pivotal Study: A Study of the Evalve Cardiovascular Valve Repair System - Endovascular Valve Edge-to-Edge REpair STudy (EVERESTIIRCT)
|EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
Prospective, multi-center, randomized study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant).
A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT.
38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM.
The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
- Mitral Valve Insufficiency
- Mitral Valve Regurgitation
- Mitral Valve Incompetence
- Mitral Regurgitation
- Mitral Insufficiency
- Experimental: 1
Percutaneous mitral valve repair using MitraClip implant. The expected number of patients in the device arm is 186 (172 evaluable)
Intervention: Device: Percutaneous mitral valve repair using MitraClip implant
- Active Comparator: 2
Mitral valve repair or replacement surgery.The expected number of patients in the active comparator arm is 93 (86 evaluable).
Intervention: Procedure: Mitral valve repair or replacement surgery
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- St Goar FG, Fann JI, Komtebedde J, Foster E, Oz MC, Fogarty TJ, Feldman T, Block PC. Endovascular edge-to-edge mitral valve repair: short-term results in a porcine model. Circulation. 2003 Oct 21;108(16):1990-3.
- Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132.
- Tamburino C, Immè S, Barbanti M, Mulè M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip® percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
- Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
- Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051.
- Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators.. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
- Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x.
- Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators.. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
- Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators.. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42.
- Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001.
- Pope NH, Lim S, Ailawadi G. Late calcific mitral stenosis after MitraClip procedure in a dialysis-dependent patient. Ann Thorac Surg. 2013 May;95(5):e113-4. doi: 10.1016/j.athoracsur.2012.10.067.
- Cikirikcioglu M, Cherian S, Schussler O, Kalangos A. Regarding "The EVEREST II Trial: design and rationale for a randomized study of the Evalve MitraClip system compared with mitral valve surgery for mitral regurgitation". Am Heart J. 2011 Jul;162(1):e11-2; author reply e13. doi: 10.1016/j.ahj.2011.04.004.
- Condado JA, Vélez-Gimón M. Catheter-based approach to mitral regurgitation. J Interv Cardiol. 2003 Dec;16(6):523-34. Review.
- Fann JI, St Goar FG. Percutaneous aortic valve replacement and mitral valve repair. Future Cardiol. 2005 May;1(3):393-403. doi: 10.1517/147966184.108.40.2063.
- Cohn LH. Percutaneous mitral valve repair with the edge-to-edge technique: a surgeon's perspective. J Am Coll Cardiol. 2005 Dec 6;46(11):2141-2.
- Condado JA, Acquatella H, Rodriguez L, Whitlow P, Vélez-Gimo M, St Goar FG. Percutaneous edge-to-edge mitral valve repair: 2-year follow-up in the first human case. Catheter Cardiovasc Interv. 2006 Feb;67(2):323-5.
- Feldman T, Glower D. Patient selection for percutaneous mitral valve repair: insight from early clinical trial applications. Nat Clin Pract Cardiovasc Med. 2008 Feb;5(2):84-90. doi: 10.1038/ncpcardio1068. Review.
- Biner S, Siegel RJ, Feldman T, Rafique AM, Trento A, Whitlow P, Rogers J, Moon M, Lindman B, Zajarias A, Glower D, Kar S; EVEREST investigators.. Acute effect of percutaneous MitraClip therapy in patients with haemodynamic decompensation. Eur J Heart Fail. 2012 Aug;14(8):939-45.
- Dang NC, Aboodi MS, Sakaguchi T, Wasserman HS, Argenziano M, Cosgrove DM, Rosengart TK, Feldman T, Block PC, Oz MC. Surgical revision after percutaneous mitral valve repair with a clip: initial multicenter experience. Ann Thorac Surg. 2005 Dec;80(6):2338-42.
- Feldman T, Wasserman HS, Herrmann HC, Gray W, Block PC, Whitlow P, St Goar F, Rodriguez L, Silvestry F, Schwartz A, Sanborn TA, Condado JA, Foster E. Percutaneous mitral valve repair using the edge-to-edge technique: six-month results of the EVEREST Phase I Clinical Trial. J Am Coll Cardiol. 2005 Dec 6;46(11):2134-40.
- Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8.
- Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40.
- Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
- Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators.. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.
- Herrmann HC, Gertz ZM, Silvestry FE, Wiegers SE, Woo YJ, Hermiller J, Segar D, Heimansohn D, Gray W, Homma S, Argenziano M, Wang A, Jollis J, Lampert MB, Alexander J, Mauri L, Foster E, Glower D, Feldman T. Effects of atrial fibrillation on treatment of mitral regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized trial. J Am Coll Cardiol. 2012 Apr 3;59(14):1312-9. doi: 10.1016/j.jacc.2011.12.023.
- Glower D, Ailawadi G, Argenziano M, Mack M, Trento A, Wang A, Lim DS, Gray W, Grayburn P, Dent J, Gillam L, Sethuraman B, Feldman T, Foster E, Mauri L, Kron I; EVEREST II Investigators.. EVEREST II randomized clinical trial: predictors of mitral valve replacement in de novo surgery or after the MitraClip procedure. J Thorac Cardiovasc Surg. 2012 Apr;143(4 Suppl):S60-3. doi: 10.1016/j.jtcvs.2012.01.047.
- Smith T, McGinty P, Bommer W, Low RI, Lim S, Fail P, Rogers JH. Prevalence and echocardiographic features of iatrogenic atrial septal defect after catheter-based mitral valve repair with the MitraClip system. Catheter Cardiovasc Interv. 2012 Oct 1;80(4):678-85. doi: 10.1002/ccd.23485.
- Mauri L, Foster E, Glower DD, Apruzzese P, Massaro JM, Herrmann HC, Hermiller J, Gray W, Wang A, Pedersen WR, Bajwa T, Lasala J, Low R, Grayburn P, Feldman T; EVEREST II Investigators.. 4-year results of a randomized controlled trial of percutaneous repair versus surgery for mitral regurgitation. J Am Coll Cardiol. 2013 Jul 23;62(4):317-28. doi: 10.1016/j.jacc.2013.04.030.
- Foster E, Kwan D, Feldman T, Weissman NJ, Grayburn PA, Schwartz A, Rogers JH, Kar S, Rinaldi MJ, Fail PS, Hermiller J, Whitlow PL, Herrmann HC, Lim DS, Glower DD; EVEREST Investigators.. Percutaneous mitral valve repair in the initial EVEREST cohort: evidence of reverse left ventricular remodeling. Circ Cardiovasc Imaging. 2013 Jul;6(4):522-30. doi: 10.1161/CIRCIMAGING.112.000098.
- Feldman T, Kar S, Elmariah S, Smart SC, Trento A, Siegel RJ, Apruzzese P, Fail P, Rinaldi MJ, Smalling RW, Hermiller JB, Heimansohn D, Gray WA, Grayburn PA, Mack MJ, Lim DS, Ailawadi G, Herrmann HC, Acker MA, Silvestry FE, Foster E, Wang A, Glower DD, Mauri L; EVEREST II Investigators.. Randomized Comparison of Percutaneous Repair and Surgery for Mitral Regurgitation: 5-Year Results of EVEREST II. J Am Coll Cardiol. 2015 Dec 29;66(25):2844-54. doi: 10.1016/j.jacc.2015.10.018.
- Wang A, Sangli C, Lim S, Ailawadi G, Kar S, Herrmann HC, Grayburn P, Foster E, Weissman NJ, Glower D, Feldman T. Evaluation of renal function before and after percutaneous mitral valve repair. Circ Cardiovasc Interv. 2015 Jan;8(1). pii: e001349. doi: 10.1161/CIRCINTERVENTIONS.113.001349.
- Glower DD, Kar S, Trento A, Lim DS, Bajwa T, Quesada R, Whitlow PL, Rinaldi MJ, Grayburn P, Mack MJ, Mauri L, McCarthy PM, Feldman T. Percutaneous mitral valve repair for mitral regurgitation in high-risk patients: results of the EVEREST II study. J Am Coll Cardiol. 2014 Jul 15;64(2):172-81. doi: 10.1016/j.jacc.2013.12.062.
- Grayburn PA, Foster E, Sangli C, Weissman NJ, Massaro J, Glower DG, Feldman T, Mauri L. Relationship between the magnitude of reduction in mitral regurgitation severity and left ventricular and left atrial reverse remodeling after MitraClip therapy. Circulation. 2013 Oct 8;128(15):1667-74. doi: 10.1161/CIRCULATIONAHA.112.001039.
- Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators.. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043.
- Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators.. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Erratum in: N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].
- Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators.. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130.
|November 2009 (Final data collection date for primary outcome measure)
Key Inclusion/Exclusion Criteria:
Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines:
- Are 18 years or older.
- If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction
- Are candidates for mitral valve surgery
- Are candidates for transseptal catheterization
- Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve
- Appropriate valve anatomy for MitraClip
- Does not need other cardiac surgery or any emergency surgery
- Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days
- Mitral valve orifice area ≥ 4 cm2
- Do not have renal insufficiency
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
|Sexes Eligible for Study:
|18 Years and older (Adult, Senior)
|Contact information is only displayed when the study is recruiting subjects
|Protocol #0401, Protocol #0401
||Ted Feldman, M.D.
||NorthShore University HealthSystem Research Institute
||Donald G Glower Jr., MD
||Duke University Medical Center, Department of Surgery