Hemiarch vs Extended Arch in Type 1 Aortic Dissection
ConditionAortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOttawa Heart Institute Research Corporation
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Hemodynamic instability/shock defined as systolic BP < 90 mm Hg
Previous cardiac surgery with sternotomy or thoracic endograft placement
Aortic arch diameter > 6cm in which a concomitant arch replacement is judged necessary
Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge.
Trial design
Treatments tested in this trial
- Hemiarch repair
- Extended arch repair
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
4London Health Sciences CentreN6A5A5, LondonOntario, Canada
University Health NetworkM5G 2C4, TorontoOntario, Canada
Montreal Heart InstituteH1T 1C8, MontrealQuebec, Canada
Institut Universitaire De Cardiologie Et De Pneumologie de QuébecG1V 4G5, QuébecQuebec, Canada
Sponsors and collaborators
Ottawa Heart Institute Research Corporation
Lead sponsor
Source ClinicalTrials.gov