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Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Aortic Dissection

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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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 Centre
Saint John, New Brunswick
Canada

Contact Study Team

Primary Contact

Carole Dube

[email protected]
5066487360
Mazankowski Alberta Heart Institute
Mazankowski Alberta Heart Institute
Edmonton, Alberta
Canada

Contact Study Team

Primary Contact

Jeff Cheng

[email protected]
7804076861
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Stephen Mardell

[email protected]
5196858500
University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Backup Contact

Linet Kiplagat, MSc

[email protected]
4032203370
Primary Contact

Vamshi Kotha, MD

[email protected]
4033898958
Study Sponsored By
University of Calgary
Participants Required
More Information
Study ID: NCT03885635