NCT01708265

Brief Summary

The purpose of this study is to compare early mitral valve repair versus a watchful waiting strategy in asymptomatic patients with severe organic mitral valve regurgitation and preserved left ventricular function.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

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

October 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 23, 2016

Status Verified

November 1, 2016

Enrollment Period

8 years

First QC Date

October 11, 2012

Last Update Submit

November 22, 2016

Conditions

Heart; Disease, Mitral(Valve)Diseases of Mitral ValveMitral Valve Insufficiency

Keywords

Mitral Valve InsufficiencyMitral Valve RegurgitationAsymptomatic Mitral Valve RegurgitationAsymptomatic Mitral Valve InsufficiencyMitral Valve RepairWatchful Waiting

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events

    The primary outcome is defined as 'time to first event'. It concerns time to first event of the composite endpoint of cardiovascular mortality, congestive heart failure, non-fatal cardiovascular events requiring hospitalization, defined as: stroke/cerebrovascular accident (CVA), atrial fibrillation (permanent or requiring hospitalization) and/or reoperation after elective MV surgery.

    Min. 5 years

Secondary Outcomes (15)

  • Cardiovascular mortality

    Min. 5 years

  • Congestive heart failure

    Min. 5 years

  • Hospitalization for nonfatal cardiovascular events

    Min. 5 years

  • All-cause mortality

    Min. 5 years

  • Costs and effectiveness

    Min. 5 years

  • +10 more secondary outcomes

Other Outcomes (2)

  • Surgery complication rate

    Min. 5 years

  • Rate for the need of facilitated surgery

    Min. 5 years

Study Arms (2)

Early mitral valve repair

ACTIVE COMPARATOR

Early mitral valve repair

Procedure: Early mitral valve repair

Watchful waiting

ACTIVE COMPARATOR

Watchful waiting

Other: Watchful waiting

Interventions

Watchful waitingOTHER

In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.

Watchful waiting
Early mitral valve repairPROCEDURE

Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.

Early mitral valve repair

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asymptomatic
  • Severe organic mitral valve regurgitation.
  • Preserved left ventricular function (left ventricular ejection fraction \>60% and left ventricular end-systolic dimension ≤45 mm)
  • The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon

You may not qualify if:

  • Pulmonary hypertension (\>50 mmHg at rest)
  • Atrial fibrillation
  • Physical inability as determined by the heart team to undergo surgery
  • Other life-threatening morbidity
  • Higher expected surgical risks in advance, according to the dedicated heart team
  • Moderate to severe kidney disease (eGFR less than 30 mL/min)
  • Flail leaflet together with a left ventricular end systolic diameter (LVESD) \>40 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

University Medical Center Utrecht (UMC Utrecht)

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Amsterdam Medisch Centrum

Amsterdam, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Related Publications (6)

  • Ling LH, Enriquez-Sarano M, Seward JB, Orszulak TA, Schaff HV, Bailey KR, Tajik AJ, Frye RL. Early surgery in patients with mitral regurgitation due to flail leaflets: a long-term outcome study. Circulation. 1997 Sep 16;96(6):1819-25. doi: 10.1161/01.cir.96.6.1819.

    PMID: 9323067BACKGROUND

  • Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.

    PMID: 15745978BACKGROUND

  • Chenot F, Montant P, Vancraeynest D, Pasquet A, Gerber B, Noirhomme PH, El Khoury G, Vanoverschelde JL. Long-term clinical outcome of mitral valve repair in asymptomatic severe mitral regurgitation. Eur J Cardiothorac Surg. 2009 Sep;36(3):539-45. doi: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.

    PMID: 19632855BACKGROUND

  • Rosenhek R, Rader F, Klaar U, Gabriel H, Krejc M, Kalbeck D, Schemper M, Maurer G, Baumgartner H. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation. 2006 May 9;113(18):2238-44. doi: 10.1161/CIRCULATIONAHA.105.599175. Epub 2006 May 1.

    PMID: 16651470BACKGROUND

  • Tietge WJ, de Heer LM, van Hessen MW, Jansen R, Bots ML, van Gilst W, Schalij M, Klautz RJ, Van den Brink RB, Van Herwerden LA, Doevendans PA, Chamuleau SA, Kluin J. Early mitral valve repair versus watchful waiting in patients with severe asymptomatic organic mitral regurgitation; rationale and design of the Dutch AMR trial, a multicenter, randomised trial. Neth Heart J. 2012 Mar;20(3):94-101. doi: 10.1007/s12471-012-0249-y.

    PMID: 22354529BACKGROUND

  • Jansen R, Kluin J, Chamuleau SA. Research versus clinical practice in asymptomatic patients with severe organic mitral regurgitation and preserved LV function. J Am Coll Cardiol. 2014 Oct 14;64(15):1639-40. doi: 10.1016/j.jacc.2014.07.964. No abstract available.

    PMID: 25301470BACKGROUND

Related Links

MeSH Terms

Conditions

DiseaseMitral Valve Insufficiency

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Steven AJ Chamuleau, MD, PhD

    University Medical Center Utrecht (UMC Utrecht)

    PRINCIPAL INVESTIGATOR

  • Jolanda Kluin, MD, PhD

    University Medical Center Utrecht (UMC Utrecht)

    PRINCIPAL INVESTIGATOR

  • Robert JM Klautz, Prof. MD PhD

    Leiden University Medical Center (LUMC Leiden)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 16, 2012

Study Start

February 1, 2013

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 23, 2016

Record last verified: 2016-11

Locations

NL(4)