NCT00538759

Brief Summary

The objective of the RADAR trial is to determine the impact of External Beam Radiation Therapy (EBRT) on aortic valve restenosis following successful percutaneous balloon aortic valvuloplasty (BAV) in elderly patients with severe calcific aortic stenosis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2007

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

October 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

October 1, 2007

Results QC Date

August 22, 2019

Last Update Submit

September 30, 2019

Conditions

Aortic Valve Stenosis

Keywords

Aortic valve stenosisBalloon aortic valvuloplastyAortic valve restenosis

Outcome Measures

Primary Outcomes (2)

  • Aortic Valve Area as a Continuous Variable, Measured by Echocardiography

    6 months

  • Incidence of Major External Beam Radiation Therapy-related Complications

    6 months

Secondary Outcomes (5)

  • NYHA Improvement

    6 months

  • CHF Rehospitalization

    6 months

  • Aortic Valve Reintervention

    6 months

  • Aortic Valve Area Late Loss Index

    6 months

  • Aortic Valve Mean Gradient

    6 months

Study Arms (2)

EBRT

EXPERIMENTAL

External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.

Device: External beam radiation therapy

Control

SHAM COMPARATOR

Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.

Other: Sham Control

Interventions

External beam radiation therapyDEVICE

Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty

EBRT
Sham ControlOTHER
Control

Eligibility Criteria

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

You may qualify if:

  • Calcific aortic valve stenosis with an echocardiographically derived AV index of less than 0.45 cm2/m2.
  • Any symptoms of severe AS, including near syncope/syncope, angina, excessive fatigue and/or shortness of breath with NYHA functional class II-IV limitation.
  • Age greater than 75 and risk of aortic valve replacement surgery greater than or equal to 15 percent. This may be assessed by using the STS Risk Predictor (see appendix C), confirmed by consultation with a cardiac surgeon experienced in high risk aortic valve surgery
  • OR by having a cardiac surgeon experienced in high risk aortic valve surgery document comorbid conditions (such as porcelain aorta, malnutrition or other comorbidities not captured by the STS scoring system) that make the risk greater than or equal to 15 percent by the estimation of the surgeon.
  • If age greater than or equal to 90 a cardiac surgeon experienced in high risk aortic valve surgery must document that BAV is a better option for the patient than aortic valve replacement surgery.
  • Probable survival greater than 6 months after successful valvuloplasty.
  • Patient is competent, willing to comply with follow-up, understands risks, benefits and alternatives and has signed the Informed Consent form.

You may not qualify if:

  • Patient has undergone previous BAV or AVR.
  • Patient is undergoing BAV as a bridge to AVR.
  • plus (severe) Aortic insufficiency by echocardiogram obtained prior to planned BAV procedure.
  • Known congenital AV abnormality (e.g., bicuspid AV).
  • ST Elevation Myocardial Infarction (STEMI) associated with CKMB greater than or equal to 3 times ULN or stroke less than or equal to 6 weeks prior to planned BAV procedure.
  • Bacterial endocarditis less than or equal to 1 year prior to planned BAV procedure.
  • Left ventricular ejection fraction less than 30% by preprocedural echocardiography.
  • Baseline mean AV gradient less than 30 mm Hg by echocardiogram unless associated with a left ventricular ejection fraction of less than 40 per cent and true severe AS confirmed by dobutamine stress echocardiogram, i.e., AVA index less than or equal to 0.45cm2/m2 at peak dobutamine infusion. See Appendix D for suggested protocol.
  • Patients who do not achieve successful BAV performed as a part of RADAR Trial: success being defined as an improvement in 4-24 hour post-valvuloplasty echocardiographically-derived AVA that is greater than 35 per cent over baseline and AVA greater than or equal to 0.7 cm2 and the absence of 4+ plus AI.
  • Percutaneous Coronary Intervention with drug eluting stent placement less than or equal to 6 months prior to planned BAV procedure or bare metal stent placement/balloon angioplasty less than or equal to 8 weeks prior to planned BAV procedure.
  • Cardiogenic shock, as defined by a consistent systolic blood pressure less than 80 mm Hg off vasopressors or less than 90 mm Hg on vasopressors.
  • Patients requiring ventilator support less than or equal to 48 hours prior to planned BAV procedure.
  • Creatinine greater than 2.2 mg/dL less than or equal to 48 hours prior to planned BAV procedure.
  • Platelet count less than or equal to 100,000/mm3 less than or equal to 48 hours prior to planned BAV procedure.
  • Hemoglobin less than or equal to 9.0 gm/dL less than or equal to 48 hours prior to planned BAV procedure.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

  • Pedersen WR, Van Tassel RA, Pierce TA, Pence DM, Monyak DJ, Kim TH, Harris KM, Knickelbine T, Lesser JR, Madison JD, Mooney MR, Goldenberg IF, Longe TF, Poulose AK, Graham KJ, Nelson RR, Pritzker MR, Pagan-Carlo LA, Boisjolie CR, Zenovich AG, Schwartz RS. Radiation following percutaneous balloon aortic valvuloplasty to prevent restenosis (RADAR pilot trial). Catheter Cardiovasc Interv. 2006 Aug;68(2):183-92. doi: 10.1002/ccd.20818.

    PMID: 16810699BACKGROUND

Related Links

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Results Point of Contact

Title
Lisa Tindell, Director of Clinical Operations
Organization
Minneapolis Heart Institute Foundation
Lisa.Tindell@allina.com
6128633816

Study Officials

  • Wes R Pedersen, MD

    Minneapolis Heart Institute Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 3, 2007

Study Start

September 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 1, 2019

Results First Posted

October 1, 2019

Record last verified: 2019-09

Locations

US(2)