ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe

NCT01288976 | Completed Results

• 1 other identifier: EU-0901
• Study Type: observational
• Target: 721
• Locations: 1 country
• Sites: 1

Brief Summary

The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.

Conditions

Mitral Valve (MV) Regurgitation

Keywords

Mitral Valve; Mitral Regurgitation; MitraClip; Mitral Valve Surgery; Mitral Valve Insufficiency or Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• MR Severity

  MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at followup is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.

  At baseline

• MR Severity

  MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe. MR severity was not consistently captured for patients in the Medical Management and Mitral Valve Surgery groups. The Medical Therapy \& Mitral Valve Surgery comparator groups were followed \& studied primarily from a health economic perspective. Availability of clinical outcomes at follow-up is limited \& has not been validated. Clinical outcomes for the comparator groups will not be reported.

  At 12 months

Secondary Outcomes (20)

• Procedure Time

  Day 0 (On the day of procedure)

• Contrast Volume

  Day 0 (On the day of procedure)

• Fluoroscopy Duration

  Day 0 (On the day of procedure)

• Number of MitraClip Devices Implanted

  Day 0 (On the day of procedure)

• ICU and Hospital Stay

  From the day of procedure throughout 12 months of study period

Study Arms (3)

MitraClip Therapy

Patients treated with the MitraClip System.

Device: MitraClip

Medical Management

Patients with MR managed non-surgically based on standard hospital clinical practice.

Drug: Medical Management

Mitral Valve Surgery

Patients with MR managed surgically (repair or replacement) based on standard hospital clinical practice.

Procedure: Mitral Valve Surgery

Interventions

MitraClip DEVICE

The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets

MitraClip Therapy

Medical Management DRUG

The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included

Medical Management

Mitral Valve Surgery PROCEDURE

The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.

Mitral Valve Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Mitral Regurgitation

You may qualify if:

• Per the current approved labeling for the Conformity European (CE) Marked MitraClip System.

You may not qualify if:

• Per the current approved labeling for the CE Marked MitraClip System.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Universitatsmedizin Gottingen

Göttingen, 37075, Germany

Location

Related Publications (21)

• 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.

  PMID: 19682161 BACKGROUND

• 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.

  PMID: 19679246 BACKGROUND

• 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.

  PMID: 19284064 BACKGROUND

• 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.

  PMID: 18703359 BACKGROUND

• 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.

  PMID: 17570634 BACKGROUND

• 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.

  PMID: 21036802 BACKGROUND

• 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.

  PMID: 20948505 BACKGROUND

• 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.

  PMID: 20876188 BACKGROUND

• 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.

  PMID: 20839359 BACKGROUND

• 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.

  PMID: 20806217 BACKGROUND

• 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.

  PMID: 20609795 BACKGROUND

• 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.

  PMID: 20598968 BACKGROUND

• 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.

  PMID: 20583881 BACKGROUND

• 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.

  PMID: 20336809 BACKGROUND

• 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.

  PMID: 20299349 BACKGROUND

• 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.

  PMID: 20219746 BACKGROUND

• 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.

  PMID: 20103209 BACKGROUND

• Maisano F, Franzen O, Baldus S, Schafer U, Hausleiter J, Butter C, Ussia GP, Sievert H, Richardt G, Widder JD, Moccetti T, Schillinger W. Percutaneous mitral valve interventions in the real world: early and 1-year results from the ACCESS-EU, a prospective, multicenter, nonrandomized post-approval study of the MitraClip therapy in Europe. J Am Coll Cardiol. 2013 Sep 17;62(12):1052-1061. doi: 10.1016/j.jacc.2013.02.094. Epub 2013 Jun 7.

  PMID: 23747789 RESULT

• Ussia GP, Cammalleri V, Scandura S, Imme S, Pistritto AM, Ministeri M, Chiaranda M, Caggegi A, Barbanti M, Aruta P, Tamburino C. Update on percutaneous mitral valve therapy: clinical results and real life experience. Minerva Cardioangiol. 2012 Feb;60(1):57-70.

  PMID: 22322574 RESULT

• Maisano F, Godino C, Giacomini A, Denti P, Buzzatti N, Arendar I, Colombo A, Alfieri O, La Canna G. Patient selection for MitraClip therapy impaired left ventricular systolic function. Minerva Cardioangiol. 2011 Oct;59(5):455-71.

  PMID: 21983306 RESULT

• Blazek S, Lurz P, Mangner N, Fuernau G, Seeburger J, Luecke C, Gutberlet M, Ender J, Desch S, Eitel I, Schuler G, Thiele H. Incidence, characteristics and functional implications of cerebral embolic lesions after the MitraClip procedure. EuroIntervention. 2015 Feb;10(10):1195-203. doi: 10.4244/EIJY14M05_10.

  PMID: 24831647 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Mitral Valve Insufficiency

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Jeffrey T Ellis
• Organization: Abbott Vascular

jeffrey.ellis@av.abbott.com

Study Officials

• Barathi Sethuraman, PhD

  Abbott Vascular Structural Heart (Evalve Inc)

  STUDY DIRECTOR

• Wolfgang Schillinger, MD

  Universitatsmedizin Gottingen

  PRINCIPAL INVESTIGATOR

• Francesco Maisano, MD

  Fondazion Ctr San Raffaele Del Monte Tabor Istituto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: February 3, 2011
• Study Start: October 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 7, 2018
• Results First Posted: December 18, 2017

Record last verified: 2018-11

Locations

DE (1)