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A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01669551
First received: August 16, 2012
Last updated: December 8, 2014
Last verified: August 2012

August 16, 2012
December 8, 2014
July 2012
December 2014   (final data collection date for primary outcome measure)
Comparison of volume intracardiac echo imaging to 2 dimensional echo [ Time Frame: Comparison study ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01669551 on ClinicalTrials.gov Archive Site
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A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy
A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy
This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Patients with structural or valvular heart disease
Structural and Valvular Heart Disease
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Structural or Valvular Heart Disease

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease

Exclusion Criteria:

  • Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01669551
UPenn 815656
No
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University of Pennsylvania
University of Pennsylvania
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Principal Investigator: Howard Herrmann, M.D. University of Pennsylvania
University of Pennsylvania
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP