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Hemiarch vs Extended Arch in Type 1 Aortic Dissection

RecruitingNAAges 18 Years - 70 YearsAllOttawa Heart Institute Research Corporation
NCT03885635 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.

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📋 Eligibility rules (as published)
Inclusion Criteria 1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection 2. Age \>18 years and \<70 years 3. Operating surgeon believes that both surgeries could be safe and effective Exclusion Criteria 1. Hemodynamic instability/shock defined as systolic BP \< 90 mm Hg 2. Previous cardiac surgery with sternotomy or thoracic endograft placement 3. Aortic arch diameter \> 6cm in which a concomitant arch replacement is judged necessary 4. Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge. 5. GCS \< 8 for more than 6 hours 6. History of cirrhosis. 7. History of chronic renal failure (baseline eGFR \< 50) 8. Metastatic malignancy 9. Pregnancy
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What it tests

  • Hemiarch repair
  • Extended arch repair
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Where

5 sites
London Health Sciences Centre
London, Canada
University of Ottawa Heart Institute
Ottawa, Canada
University Health Network
Toronto, Canada
Montreal Heart Institute
Montreal, Canada
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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