Balloon Aortic Valvuloplasty During Surgical Aortic Valve... | NCT00584116

Studies
Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement

NCT00584116

Sponsor

University of California, Davis

Status

Completed

Last Update Posted

May 30, 2017Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Aortic Stenosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Dec 26, 2007

First Submission Date that Met QC Criteria

Dec 26, 2007

First Posted Date

Jan 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2017

Last Update Posted Date

May 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (BAV) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (SAVR) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
aortic annulus size	Show the correlation between the size of the aortic annulus measured intra-operatively with surgical rings (gold standard) with other methods of aortic annulus measurement that would not require surgical intervention (CT, TEE, TTE)	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older
Any patient with severe, symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.
- Severe AS: aortic valve area (AVA) ≤ 1.0 cm2
- Symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to AS

Exclusion Criteria:

Emergent surgical aortic valve replacement.
Inability to undergo TTE or TEE intra-operatively.
Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any patient with severe symptomatic calcific aortic stenosis (AS) referred for elective surgical aortic valve replacement.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason Rogers, MD	University of California, Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC Davis Medical Center		Sacramento	California	95817	United States

Label	URL
Clinical Trials at UC Davis Medical Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided