Feasibility Study of a Percutaneous Mitral Valve Repair System. - Full Text View

Sponsor:	Evalve
Information provided by:	Evalve
ClinicalTrials.gov Identifier:	NCT00209339

Purpose

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.

Condition	Intervention	Phase
Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency	Device: Percutaneous mitral valve repair (MitraClip Implant)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Study of the Evalve Cardiovascular Valve Repair System Endovascular Valve Edge-to-Edge REpair STudy (EVEREST I).

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Evalve:

Primary Outcome Measures:

Acute safety at 30 days, defined as freedom from major adverse events (MAE), defined as a combined clinical endpoint of death, myocardial infarction, cardiac tamponade, cardiac surgery for failed Clip, Clip detachment, stroke and septicemia. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

30 day and 6-month assessment of mitral regurgitation severity determined by echocardiography. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	July 2003
Estimated Study Completion Date:	July 2011
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardovascular Valve Repair System.

Other Name: EVEREST I, MitraClip

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209339

Locations

United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201

Sponsors and Collaborators

Evalve

Investigators

Principal Investigator:

Ted Feldman, M.D.

NorthShore University HealthSystem Research Institute

More Information

Additional Information:

Evalve corporate web site This link exits the ClinicalTrials.gov site

Web site listing study sites and describing mitral regurgitation, symptoms, clinical consequences and treatments This link exits the ClinicalTrials.gov site

Publications:

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.

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. Epub 2003 Oct 6.

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. Epub 2004 Aug 9.

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. Epub 2007 Jun 13.

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. 2008 Aug 12; [Epub ahead of print]

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.

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. Epub 2009 Jul 24.

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.

Franzen O, Baldus S, Rudolph V, Meyer S, Knap M, Koschyk D, Treede H, Barmeyer A, Schofer J, Costard-Jäckle A, Schlüter 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. Epub 2010 Mar 10.

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. Epub 2010 Mar 18.

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.

Jönsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47.

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.

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.

Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polo?ski 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.

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.

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. 2010 Sep 27; [Epub ahead of print]

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.

Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2010 Oct 29; [Epub ahead of print] No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. Epub 2011 Mar 21.

Responsible Party:	Elizabeth McDermott, Divisional Vice President of Regulatory and Clinical Affairs, Abbott Vascular Structural Heart (Evalve, Inc)
ClinicalTrials.gov Identifier:	NCT00209339 History of Changes
Other Study ID Numbers:	Protocol #0301, Protocol #0301
Study First Received:	September 13, 2005
Last Updated:	February 2, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Evalve:

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

Additional relevant MeSH terms:

Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012