NCT00005199

Brief Summary

To establish a registry in order to collect and analyze baseline and outcome data on patients with severe valvular stenosis treated with balloon valvuloplasty.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jun 1987

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

June 1, 1987

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1994

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2000

First QC Date

May 25, 2000

Last Update Submit

June 23, 2005

Conditions

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (11)

  • Reid CL, Otto CM, Davis KB, Labovitz A, Kisslo KB, McKay CR. Influence of mitral valve morphology on mitral balloon commissurotomy: immediate and six-month results from the NHLBI Balloon Valvuloplasty Registry. Am Heart J. 1992 Sep;124(3):657-65. doi: 10.1016/0002-8703(92)90274-y.

    PMID: 1514494BACKGROUND
  • Davidson CJ, Bashore TM, Mickel M, Davis K. Balloon mitral commissurotomy after previous surgical commissurotomy. The National Heart, Lung, and Blood Institute Balloon Valvuloplasty Registry participants. Circulation. 1992 Jul;86(1):91-9. doi: 10.1161/01.cir.86.1.91.

    PMID: 1617794BACKGROUND
  • Otto CM, Davis KB, Holmes DR Jr, O'Neill W, Ferguson J, Bashore TM, Bonan R. Methodologic issues in clinical evaluation of stenosis severity in adults undergoing aortic or mitral balloon valvuloplasty. The NHLBI Balloon Valvuloplasty Registry. Am J Cardiol. 1992 Jun 15;69(19):1607-16. doi: 10.1016/0002-9149(92)90712-8.

    PMID: 1598878BACKGROUND
  • Complications and mortality of percutaneous balloon mitral commissurotomy. A report from the National Heart, Lung, and Blood Institute Balloon Valvuloplasty Registry. Circulation. 1992 Jun;85(6):2014-24. doi: 10.1161/01.cir.85.6.2014.

    PMID: 1591821BACKGROUND
  • Multicenter experience with balloon mitral commissurotomy. NHLBI Balloon Valvuloplasty Registry Report on immediate and 30-day follow-up results. The National Heart, Lung, and Blood Institute Balloon Valvuloplasty Registry Participants. Circulation. 1992 Feb;85(2):448-61. doi: 10.1161/01.cir.85.2.448.

    PMID: 1735143BACKGROUND
  • Otto CM, Nishimura RA, Davis KB, Kisslo KB, Bashore TM. Doppler echocardiographic findings in adults with severe symptomatic valvular aortic stenosis. Balloon Valvuloplasty Registry Echocardiographers. Am J Cardiol. 1991 Dec 1;68(15):1477-84. doi: 10.1016/0002-9149(91)90282-p.

    PMID: 1746430BACKGROUND
  • Percutaneous balloon aortic valvuloplasty. Acute and 30-day follow-up results in 674 patients from the NHLBI Balloon Valvuloplasty Registry. Circulation. 1991 Dec;84(6):2383-97. doi: 10.1161/01.cir.84.6.2383.

    PMID: 1959194BACKGROUND
  • Otto CM, Mickel MC, Kennedy JW, Alderman EL, Bashore TM, Block PC, Brinker JA, Diver D, Ferguson J, Holmes DR Jr, et al. Three-year outcome after balloon aortic valvuloplasty. Insights into prognosis of valvular aortic stenosis. Circulation. 1994 Feb;89(2):642-50. doi: 10.1161/01.cir.89.2.642.

    PMID: 8313553BACKGROUND
  • Otto CM, Davis KB, Reid CL, Slater JN, Kronzon I, Kisslo KB, Bashore TM. Relation between pulmonary artery pressure and mitral stenosis severity in patients undergoing balloon mitral commissurotomy. Am J Cardiol. 1993 Apr 1;71(10):874-8. doi: 10.1016/0002-9149(93)90844-3. No abstract available.

    PMID: 8456774BACKGROUND
  • Douglas PS, Otto CM, Mickel MC, Labovitz A, Reid CL, Davis KB. Gender differences in left ventricle geometry and function in patients undergoing balloon dilatation of the aortic valve for isolated aortic stenosis. NHLBI Balloon Valvuloplasty Registry. Br Heart J. 1995 Jun;73(6):548-54. doi: 10.1136/hrt.73.6.548.

    PMID: 7626355BACKGROUND
  • Engbaek F, Voldby B. Radioimmunoassay of serotonin (5-hydroxytryptamine) in cerebrospinal fluid, plasma, and serum. Clin Chem. 1982 Apr;28(4 Pt 1):624-8.

    PMID: 7074830BACKGROUND

MeSH Terms

Conditions

Heart DiseasesMitral Valve StenosisAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHeart Valve DiseasesAortic Valve DiseaseVentricular Outflow Obstruction

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

June 1, 1987

Study Completion

November 1, 1994

Last Updated

June 24, 2005

Record last verified: 2000-05