Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
• Age \>18 years and \<70 years
• Operating surgeon believes that both surgeries could be safe and effective
Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Montreal Heart Institute
RECRUITING
Montreal
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
RECRUITING
Québec
University Health Network
RECRUITING
Toronto
Contact Information
Primary
Khatira Mehdiyeva
kmehdiyeva@ottawaheart.ca
613-696-7000
Backup
Alice Black
AlBlack@ottawaheart.ca
403-389-8958
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 50
Treatments
Active_comparator: Hemiarch repair
Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.
Active_comparator: Extended arch repair
Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.
Authors
Related Therapeutic Areas
Sponsors
Leads: Ottawa Heart Institute Research Corporation