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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Structural and Valvular Heart Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Structural or Valvular Heart Disease

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Herrmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

References

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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.

Reference Type DERIVED

PMID: 24930123 (View on PubMed)

Kadakia MB, Silvestry FE, Herrmann HC. Intracardiac echocardiography-guided transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):497-501. doi: 10.1002/ccd.25409. Epub 2014 Feb 10.