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Mitral Regurgitation FunctionalOne-Plus-OneNCT03503851

Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation

A study testing MitraClip implantation in people with Mitral Regurgitation Functional, run by Asklepios proresearch.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Regurgitation Functional
What is being tested?
MitraClip implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
May 2018to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • patients with primary regurgitation

About this study

Official title: Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation (One-Plus-One)

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.

Read the detailed description

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.

Purpose To demonstrate the noninferiority of a 1-clip strategy vs. a 2-clip strategy of MitraClip implantation, when the second clip in the 2-clip study arm is implanted for stabilizing/supporting purposes.

Being tested
MitraClip implantation
Keywords
Mitral Regurgitation, transcatheter mitral valve repair, MitraClip
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitraClip implantationDevice

    Device to approximate the mitral valve leaflets

Study groups in NCT03503851
Study groupRoleWhat they receive
One CLIPActive comparatorImplantation of single MitraClip
Receives: Device: MitraClip implantation
Two CLIPsActive comparatorImplantation of second MitraClip (after successful Implantation of single MitraClip)
Receives: Device: MitraClip implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of number of participants who died death within one year

    death

    Measured: 1 year

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

    heart failure rehospitalization

    Measured: 1 year

  3. Evaluation of number of participants with recurrent regurgitation within one year

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

    Measured: 1 year

Secondary outcomes (15)

  1. death

    freedom from death (1-year)

    Measured: 1 year

  2. heart failure

    freedom from heart failure (1-year)

    Measured: 1 year

  3. rehospitalization

    rehospitalization

    Measured: 1-year

  4. regurgitation

    freedom from recurrence of mitral regurgitation (>2+; 1-year)

    Measured: 1-year

  5. success rate

    procedural success rate in 2-clip arm

    Measured: 1-year

  6. procedure duration

    procedure duration

    Measured: 1-year

  7. total device time

    total device time

    Measured: 1-year

  8. fluoroscopy time

    fluoroscopy time

    Measured: 1-year

  9. contrast volume

    contrast volume

    Measured: 1-year

  10. complications

    periprocedural (30-day) complications

    Measured: 1-year

  11. echocardiographic variables

    The following echocardiographic variables will be assessed by 2-dimensional transthoracic echocardiography at 12 months: Left ventricular (LV) end-diastolic diameter and volume; LV end-systolic diameter and volume; LV ejection fraction; LV outflow tract diameter and velocity time integral in LV outflow tract (to calculate forward stroke volume).

    Measured: 1-year

  12. changes in echocardiographic variables

    Changes from baseline to 12 months in echocardiographically assessed (at both time points) LV end-diastolic diameter and volume; LV end-systolic diameter and volume; LV ejection fraction; and forward stroke volume.

    Measured: 1-year

  13. NYHA

    NYHA functional class

    Measured: 1-year

  14. 6-minutes walk

    6-minutes walk distance

    Measured: 1-year

  15. quality of life

    Assessment of the Minnesota Living With Heart Failure Questionnaire (MLHFQ) quality-of-life score. The questionnaire consists of 21 quality-of-life questions to be answered by the patient on a grading scale of 0 (best) to 5 (worst). Thus, the overall MLHFQ score ranges from 0 to 105.

    Measured: 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study startMay 2018 (estimated)
  3. Primary completionNov 2019 (estimated)
  4. Study completionDec 2020 (estimated)

Why it stopped: Delay during study initiation. Change of MitraClip design in meantime.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, multi-center, randomized, parallel-arm trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503851
Sponsor's protocol ID
#3150
Acronym
One-Plus-One
Status last verified
Jan 2019
First submitted
6 Mar 2018
Last updated
3 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26718672

  • 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.

    PubMed 21463154

  • 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.

    PubMed 20219746

  • 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.

    PubMed 22685268

  • 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.

    PubMed 23433761

  • 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.

    PubMed 23343688

  • 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.

    PubMed 23747789

  • 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.

    PubMed 25169171

  • 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.

    PubMed 25601532

Questions about this trial

What is this clinical trial studying?

A study testing MitraClip implantation in people with Mitral Regurgitation Functional, run by Asklepios proresearch.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of number of participants who died death within one year (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503851, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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