NCT03885635 Hemiarch vs Extended Arch in Type 1 Aortic Dissection
| NCT ID | NCT03885635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-30 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-07-30 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Munir Boodhwani, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT03885635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03885635 currently recruiting?
Yes, NCT03885635 is actively recruiting participants. Contact the research team at kmehdiyeva@ottawaheart.ca for enrollment information.
Where is the NCT03885635 trial being conducted?
This trial is being conducted at London, Canada, Ottawa, Canada, Toronto, Canada, Montreal, Canada and 1 additional location.
Who is sponsoring the NCT03885635 clinical trial?
NCT03885635 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Munir Boodhwani, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 50 participants.