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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
  Purpose

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.


Condition
Structural and Valvular Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A PHASE 1 FEASIBILITY STUDY OF VOLUME INTRACARDIAC ECHO IN ASSESSMENT OF PATIENTS WITH STRUCTURAL AND VALVULAR HEART DISEASE UNDERGOING PERCUTANEOUS TRANSCATHETER THERAPY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Structural or Valvular Heart Disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with structural or valvular heart disease

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669551

Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Howard Herrmann, M.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01669551     History of Changes
Other Study ID Numbers: UPenn 815656
Study First Received: August 16, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013