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Aortic Valve StenosisPhase 2/3RADARNCT00538759

Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

A Phase 2/3 study testing External beam radiation therapy in people with Aortic Valve Stenosis, run by Minneapolis Heart Institute Foundation at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
External beam radiation therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
2 sitesUnited States
Study dates
Sep 2007to Jul 2010
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • Patient has undergone previous BAV or AVR.
  • Patient is undergoing BAV as a bridge to AVR.
  • 4 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.
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  • 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.
  • Known allergy/sensitivity to ASA.
  • Known allergy/sensitivity to both clopidogrel and ticlopidine.
  • Gastrointestinal bleed requiring transfusion less than or equal to 2 weeks prior to planned BAV procedure.
  • Prior external beam radiation therapy to the chest that, in the judgment of the radiation oncologist, will compromise patient safety or interfere with the interpretation of the study results. This includes any prior radiation to the thoracic contents, except for radiation treatments for malignant or benign lesions of the skin.
  • Untreated pneumonia or other systemic infection associated with fever greater than 38.5˚c or WBC count greater than 10,000 less than or equal to 72 hours prior to planned BAV procedure.
  • Concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival of less than 6 months.
  • Major surgery less than or equal to 2 weeks prior to planned BAV procedure.
  • Any illness or condition which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.
  • Involvement in any study of an investigational drug, device or procedure less than or equal to 30 days prior to planned BAV procedure.
  • Previous enrollment in this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

Other trials in United States

About this study

Official title: RADiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

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.

Read the detailed description

The RADAR trial is a prospective, randomized, double-blind, sham-controlled, two-stage, adaptive clinical trial. Following successful Balloon Aortic Valvuloplasty, patients with severe aortic stenosis will be randomized in a 2:1 fashion to External Beam Radiation Therapy (EBRT) plus standard medical therapy or standard medical therapy along with sham EBRT (placebo). During Stage One, approximately 110 patients will be enrolled in order to have 80 patients randomized and 66 patients with valid 6 month data. The sample size for Stage Two will be calculated at the end of Stage One. At the time of study commencement, the expectation is that the total sample size will be approximately 155 patients with valid 6-month data, and thus 195 will be randomized and up to 250 enrolled.

Patients will be followed for a period of two (2) years. Echocardiographic and clinical endpoint data will be collected and analyzed.

Being tested
External beam radiation therapy, Sham Control
Keywords
Aortic valve stenosis, Balloon aortic valvuloplasty, Aortic valve restenosis
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • External beam radiation therapyDevice

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

  • Sham ControlOther

Study groups in NCT00538759
Study groupRoleWhat they receive
EBRTExperimentalExternal beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
Receives: Device: External beam radiation therapy
ControlSham comparatorSham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.
Receives: Other: Sham Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aortic Valve Area as a Continuous Variable, Measured by Echocardiography

    Measured: 6 months

  2. Incidence of Major External Beam Radiation Therapy-related Complications

    Measured: 6 months

Secondary outcomes (5)

  1. NYHA Improvement

    Improvement from pre-procedural NYHA class. Patients' heart failure were graded according to the severity of their symptoms. The New York Heart Association (NYHA) Functional Classification was used. It places patients in one of four categories based on how much they are limited during physical activity.

    I No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).

    II Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

    III Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

    IV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

    Measured: 6 months

  2. CHF Rehospitalization

    Measured: 6 months

  3. Aortic Valve Reintervention

    Measured: 6 months

  4. Aortic Valve Area Late Loss Index

    The difference between the Aortic Valve Area at 6 months and the Aortic Valve Area post procedure indexed to the subject

    Measured: 6 months

  5. Aortic Valve Mean Gradient

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2007 (estimated)
  2. Study startSep 2007
  3. Primary completionJul 2010
  4. Study completionJul 2010

Why it stopped: Funding shortfall

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00538759
Sponsor's protocol ID
G060198
Acronym
RADAR
Status last verified
Sep 2019
First submitted
1 Oct 2007
Last updated
1 Oct 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16810699

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing External beam radiation therapy in people with Aortic Valve Stenosis, run by Minneapolis Heart Institute Foundation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aortic Valve Area as a Continuous Variable, Measured by Echocardiography (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00538759, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.

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