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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014