Actively Recruiting
Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Led by Ottawa Heart Institute Research Corporation · Updated on 2025-09-22
50
Participants Needed
4
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
- Age greater than 18 years and less than 70 years
- Operating surgeon believes both surgical options are safe and effective
You will not qualify if you...
- Hemodynamic instability or shock defined as systolic blood pressure less than 90 mm Hg
- Previous cardiac surgery with sternotomy or thoracic endograft placement
- Aortic arch diameter greater than 6 cm requiring concomitant arch replacement
- Salvage operations where survival to hospital discharge is unlikely
- Glasgow Coma Scale less than 8 for more than 6 hours
- History of cirrhosis
- History of chronic renal failure with baseline eGFR less than 50
- Metastatic malignancy
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
London Health Sciences Centre
London, Ontario, Canada, N6A5A5
Actively Recruiting
2
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
3
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
4
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
K
Khatira Mehdiyeva
CONTACT
A
Alice Black
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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