Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Aortic DissectionHEADSTART 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.
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 to 70
Participation Criteria
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
Study Location
New Brunswick Heart Centre
New Brunswick Heart CentreSaint John, New Brunswick
Canada
Contact Study Team
Mazankowski Alberta Heart Institute
Mazankowski Alberta Heart InstituteEdmonton, Alberta
Canada
Contact Study Team
London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
Contact Study Team
University of Calgary
University of CalgaryCalgary, Alberta
Canada
Contact Study Team
- Study Sponsored By
- University of Calgary
- Participants Required
- More Information
- Study ID:
NCT03885635