NCT00269165

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
Last Updated

May 31, 2010

Status Verified

May 1, 2010

First QC Date

December 22, 2005

Last Update Submit

May 28, 2010

Conditions

Interventions

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Ron Waksman, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

November 1, 2005

Last Updated

May 31, 2010

Record last verified: 2010-05