NCT03503851

Brief Summary

Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

March 6, 2018

Last Update Submit

January 2, 2019

Conditions

Mitral Regurgitation Functional

Keywords

Mitral Regurgitationtranscatheter mitral valve repairMitraClip

Outcome Measures

Primary Outcomes (3)

  • Evaluation of number of participants who died death within one year

    death

    1 year

  • Evaluation of number of rehospitalizations due to heart failure among patients receiving one or two clips

    heart failure rehospitalization

    1 year

  • Evaluation of number of participants with recurrent regurgitation within one year

    recurrence of mitral regurgitation (\>grade 2+ at 1 year)

    1 year

Secondary Outcomes (15)

  • death

    1 year

  • heart failure

    1 year

  • rehospitalization

    1-year

  • regurgitation

    1-year

  • success rate

    1-year

  • +10 more secondary outcomes

Study Arms (2)

One CLIP

ACTIVE COMPARATOR

Implantation of single MitraClip

Device: MitraClip implantation

Two CLIPs

ACTIVE COMPARATOR

Implantation of second MitraClip (after successful Implantation of single MitraClip)

Device: MitraClip implantation

Interventions

MitraClip implantationDEVICE

Device to approximate the mitral valve leaflets

One CLIPTwo CLIPs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of a structural abnormality of the mitral valve giving rise to MR.
  • MR severity of US grade 3+ or 4+ of central or noncentral origin
  • Patient must consent to randomization in the hybrid operating theater upon successful implantation of a single MitraClip. Written informed consent must be provided prior to the MitraClip procedure.

You may not qualify if:

  • patients with primary regurgitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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):2844-2854. doi: 10.1016/j.jacc.2015.10.018.

    PMID: 26718672BACKGROUND

  • 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. Epub 2011 Apr 4.

    PMID: 21463154BACKGROUND

  • 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: 20219746BACKGROUND

  • Baldus S, Schillinger W, Franzen O, Bekeredjian R, Sievert H, Schofer J, Kuck KH, Konorza T, Mollmann H, Hehrlein C, Ouarrak T, Senges J, Meinertz T; German Transcatheter Mitral Valve Interventions (TRAMI) investigators. MitraClip therapy in daily clinical practice: initial results from the German transcatheter mitral valve interventions (TRAMI) registry. Eur J Heart Fail. 2012 Sep;14(9):1050-5. doi: 10.1093/eurjhf/hfs079. Epub 2012 Jun 8.

    PMID: 22685268BACKGROUND

  • Grasso C, Capodanno D, Scandura S, Cannata S, Imme S, Mangiafico S, Pistritto A, Ministeri M, Barbanti M, Caggegi A, Chiaranda M, Dipasqua F, Giaquinta S, Occhipinti M, Ussia G, Tamburino C. One- and twelve-month safety and efficacy outcomes of patients undergoing edge-to-edge percutaneous mitral valve repair (from the GRASP Registry). Am J Cardiol. 2013 May 15;111(10):1482-7. doi: 10.1016/j.amjcard.2013.01.300. Epub 2013 Feb 20.

    PMID: 23433761BACKGROUND

  • Surder D, Pedrazzini G, Gaemperli O, Biaggi P, Felix C, Rufibach K, der Maur CA, Jeger R, Buser P, Kaufmann BA, Moccetti M, Hurlimann D, Buhler I, Bettex D, Scherman J, Pasotti E, Faletra FF, Zuber M, Moccetti T, Luscher TF, Erne P, Grunenfelder J, Corti R. Predictors for efficacy of percutaneous mitral valve repair using the MitraClip system: the results of the MitraSwiss registry. Heart. 2013 Jul;99(14):1034-40. doi: 10.1136/heartjnl-2012-303105. Epub 2013 Jan 23.

    PMID: 23343688BACKGROUND

  • 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: 23747789BACKGROUND

  • Nickenig G, Estevez-Loureiro R, Franzen O, Tamburino C, Vanderheyden M, Luscher TF, Moat N, Price S, Dall'Ara G, Winter R, Corti R, Grasso C, Snow TM, Jeger R, Blankenberg S, Settergren M, Tiroch K, Balzer J, Petronio AS, Buttner HJ, Ettori F, Sievert H, Fiorino MG, Claeys M, Ussia GP, Baumgartner H, Scandura S, Alamgir F, Keshavarzi F, Colombo A, Maisano F, Ebelt H, Aruta P, Lubos E, Plicht B, Schueler R, Pighi M, Di Mario C; Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Research Programme of the European Society of Cardiology. Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011-2012 Pilot European Sentinel Registry. J Am Coll Cardiol. 2014 Sep 2;64(9):875-84. doi: 10.1016/j.jacc.2014.06.1166.

    PMID: 25169171BACKGROUND

  • Eggebrecht H, Schelle S, Puls M, Plicht B, von Bardeleben RS, Butter C, May AE, Lubos E, Boekstegers P, Ouarrak T, Senges J, Schmermund A. Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry. Catheter Cardiovasc Interv. 2015 Oct;86(4):728-35. doi: 10.1002/ccd.25838. Epub 2015 Feb 12.

    PMID: 25601532BACKGROUND

Related Links

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Karl-Heinz Kuck, MD, PHD

    Asklepios Klinik St. Georg, Dept. of Cardiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multi-center, randomized, parallel-arm trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

April 20, 2018

Study Start

May 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 1, 2020

Last Updated

January 3, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share