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A PHASE 1 FEASIBILITY STUDY OF VOLUME INTRACARDIAC ECHO IN ASSESSMENT OF PATIENTS WITH STRUCTURAL AND VALVULAR HEART DISEASE UNDERGOING PERCUTANEOUS TRANSCATHETER THERAPY

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01669551
First received: August 16, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

August 16, 2012
August 16, 2012
July 2012
July 2013   (final data collection date for primary outcome measure)
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No Changes Posted
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A PHASE 1 FEASIBILITY STUDY OF VOLUME INTRACARDIAC ECHO IN ASSESSMENT OF PATIENTS WITH STRUCTURAL AND VALVULAR HEART DISEASE UNDERGOING PERCUTANEOUS TRANSCATHETER THERAPY
A PHASE 1 FEASIBILITY 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.

Not Provided
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
Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
December 2013
July 2013   (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
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01669551
UPenn 815656
No
University of Pennsylvania
University of Pennsylvania
Not Provided
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