Adjuvant Radiation in Aortic Valvuloplasty - ARAVA | NCT00269165

Studies
Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

NCT00269165

Sponsor

Medstar Health Research Institute

Status

Terminated

Last Update Posted

May 31, 2010Estimated

Enrollment

Phase

Phase 3

Conditions

Aortic Valve Stenosis

Interventions

Balloon Aortic Valvuloplasty
External Beam Radiation

Countries

Not provided

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 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 22, 2005

First Submission Date that Met QC Criteria

Dec 22, 2005

First Posted Date

Dec 23, 2005Estimated

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 28, 2010

Last Update Posted Date

May 31, 2010Estimated

Description Module

Brief Summary

This study will examine the effect of external beam radiation therapy in the prevention of restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic stenosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe Aortic Stenosis
NYHA Class 2-4 CHF Symptoms
Age > 75
EuroSCORE > 7
Prohibitively High Risk for Aortic Valve Replacement Surgery as Designated by a Cardiac Surgeon

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ron Waksman, MD	Medstar Health Research Institute	Principal Investigator

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

Name	Type	Description	Arm Group Labels	Other Names
Balloon Aortic Valvuloplasty	Procedure
External Beam Radiation	Procedure