Clinical trial NCT00209339: Feasibility Study of a Percutaneous Mitral Valve Repair System.
Official title: A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Keywords: Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve
MR
Mitral Valve Prolapse
E2E - Edge to Edge
Alfieri Technique
MitraClip
Functional MR
Degenerative MR
Echocardiogram
CAD - Coronary Artery Disease
Heart Failure
Heart Attack
EVEREST
EVEREST I
EVEREST II
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.

Detailed description: Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System.

The study is a prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. A minimum of 20 patients will be enrolled (an additional maximum of 12 roll in-patients, a maximum of 2 per site, may be enrolled and analyzed separately). Patients will undergo 30-day, 6 month and 12 month clinical follow-up.

Up to 12 clinical sites throughout the US may participate.

The primary endpoint is acute safety at thirty days, with a secondary efficacy endpoint of reduction of MR.

Eligibility criteria: Inclusion Criteria:

* Have moderate to severe mitral regurgitation, symptomatic or asymptomatic with evidence of left ventricular dysfunction;
* Experience regurgitation origination from the central two-thirds of the valve;
* Qualify as a candidate for mitral valve surgery including cardiopulmonary bypass.

Exclusion Criteria:

* Ejection fraction \< 30%
* Endocarditis
* Rheumatic heart disease
* Renal insufficiency

Primary outcomes:
measure: Mitral Regurgitation Severity
timeFrame: At baseline
measure: Mitral Regurgitation Severity
timeFrame: At discharge or within 30 days of the procedure
measure: Mitral Regurgitation Severity
timeFrame: At 12 months
measure: Mitral Regurgitation Severity
timeFrame: At 24 months
measure: Mitral Regurgitation Severity
timeFrame: At 3 years
measure: Mitral Regurgitation Severity
timeFrame: At 4 years
measure: Mitral Regurgitation Severity
timeFrame: At 5 years
measure: Major Adverse Events (MAE)
timeFrame: Through 30 days
measure: Major Adverse Events (MAE)
timeFrame: Through 6 Months
Secondary outcomes:
measure: Procedure Time
timeFrame: At day 0 (on the day of index procedure)
measure: Device Time
timeFrame: At day 0 (on the day of index procedure)
measure: Contrast Volume
timeFrame: At day 0 (on the day of index procedure)
measure: Fluoroscopy Duration
timeFrame: At day 0 (on the day of index procedure)
measure: Number of Mitraclip Devices Implanted
timeFrame: At day 0 (on the day of index procedure)
measure: Intra-procedural Major Adverse Events
timeFrame: At day 0 (on the day of index procedure)
measure: Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration
timeFrame: Post index procedure within 30 days
measure: Post-procedure Hospital Stay
timeFrame: Post-index procedure until hospital discharge (1 to 19 days)
measure: Second Intervention to Place a Second MitraClip Device
timeFrame: Post index procedure through 5 years
measure: MitraClip Device Embolizations and Single Leaflet Device Attachment
timeFrame: Post index procedure through 5 years
measure: Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
timeFrame: At baseline
measure: Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
timeFrame: At 12 months
measure: Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
timeFrame: At 24 months
measure: Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
timeFrame: At 3 Years
measure: Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
timeFrame: At 4 Years
measure: Mitral Valve Surgery Post-MitraClip Device Implant Procedure (Kaplan-Meier Freedom From Mitral Valve Surgery)
timeFrame: At 5 Years
measure: Death (Kaplan-Meier Freedom From Death)
timeFrame: Within 30 days of the procedure
measure: Death (Kaplan-Meier Freedom From Death)
timeFrame: At 12 months
measure: Death (Kaplan-Meier Freedom From Death)
timeFrame: At 24 months
measure: Death (Kaplan-Meier Freedom From Death)
timeFrame: At 3 years
measure: Death (Kaplan-Meier Freedom From Death)
timeFrame: At 4 years
measure: Death (Kaplan-Meier Freedom From Death)
timeFrame: At 5 years
measure: Major Vascular and Bleeding Complications
timeFrame: Through 30 days
measure: Major Vascular and Bleeding Complications
timeFrame: Through 6 Months
measure: Other Secondary Safety Events
timeFrame: Through 30 days
measure: Other Secondary Safety Events
timeFrame: Through 6 months
measure: Left Ventricular End Diastolic Volume
timeFrame: Baseline
measure: Left Ventricular End Diastolic Volume
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Left Ventricular End Diastolic Volume
timeFrame: 12 months
measure: Left Ventricular End Diastolic Volume
timeFrame: 24 months
measure: Left Ventricular End Diastolic Volume
timeFrame: 60 months
measure: Left Ventricular End Systolic Volume
timeFrame: Baseline
measure: Left Ventricular End Systolic Volume
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Left Ventricular End Systolic Volume
timeFrame: 12 months
measure: Left Ventricular End Systolic Volume
timeFrame: 24 months
measure: Left Ventricular End Systolic Volume
timeFrame: 60 months
measure: Mitral Valve Area - Single Orifice
timeFrame: Baseline
measure: Mitral Valve Area - Single Orifice
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Mitral Valve Area - Single Orifice
timeFrame: 12 months
measure: Mitral Valve Area - Single Orifice
timeFrame: 24 months
measure: Mitral Valve Area - Single Orifice
timeFrame: 60 months
measure: Mitral Valve Area (MVA) by Pressure Half-Time
timeFrame: Baseline
measure: Mitral Valve Area (MVA) by Pressure Half-Time
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Mitral Valve Area (MVA) by Pressure Half-Time
timeFrame: 12 months
measure: Mitral Valve Area (MVA) by Pressure Half-Time
timeFrame: 24 months
measure: Mitral Valve Area (MVA) by Pressure Half-Time
timeFrame: 60 months
measure: Mitral Valve Gradient
timeFrame: Baseline
measure: Mitral Valve Gradient
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Mitral Valve Gradient
timeFrame: 12 months
measure: Mitral Valve Gradient
timeFrame: 24 months
measure: Mitral Valve Gradient
timeFrame: 60 months
measure: Cardiac Output
timeFrame: Baseline
measure: Cardiac Output
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Cardiac Output
timeFrame: 12 months
measure: Cardiac Output
timeFrame: 24 months
measure: Cardiac Output
timeFrame: 60 months
measure: Cardiac Index
timeFrame: Baseline
measure: Cardiac Index
timeFrame: During the hospital stay with a maximum of 3 days post index procedure (Discharge)
measure: Cardiac Index
timeFrame: 12 months
measure: Cardiac Index
timeFrame: 24 months
measure: Cardiac Index
timeFrame: 60 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: Baseline
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 6 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 30 days
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 12 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 18 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 24 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 36 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 48 months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: 60 months
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Ted Feldman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1161/01.CIR.0000096052.78331.CA. Epub 2003 Oct 6.
citation: Fann JI, St Goar FG, Komtebedde J, Oz MC, Block PC, Foster E, Butany J, Feldman T, Burdon TA. Beating heart catheter-based edge-to-edge mitral valve procedure in a porcine model: efficacy and healing response. Circulation. 2004 Aug 24;110(8):988-93. doi: 10.1161/01.CIR.0000139855.12616.15. Epub 2004 Aug 9.
citation: 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. doi: 10.1002/ccd.20917.
citation: 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. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13.
citation: 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. Epub 2008 Aug 13.
citation: 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. doi: 10.4244/eijv4i4a76.
citation: 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. Epub 2009 Jul 24.
citation: 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.
citation: Franzen O, Baldus S, Rudolph V, Meyer S, Knap M, Koschyk D, Treede H, Barmeyer A, Schofer J, Costard-Jackle A, Schluter M, Reichenspurner H, Meinertz T. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J. 2010 Jun;31(11):1373-81. doi: 10.1093/eurheartj/ehq050. Epub 2010 Mar 10.
citation: 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. Epub 2010 Mar 18.
citation: Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
citation: Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23.
citation: 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.
citation: Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
citation: Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish.
citation: 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.
citation: Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
citation: Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
citation: 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. Epub 2010 Oct 29. No abstract available.
citation: 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.
citation: 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. Epub 2013 Apr 30.
citation: 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.
citation: 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. Epub 2011 Mar 21.