Study Summary
This trial is investigating whether it is better to do surgery or just monitor patients with an enlarged ascending aorta.
Eligible Conditions
- Ascending Aortic Aneurysm Enlargement
- Ascending Aortic Aneurysm
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 2 years
2 years
All-cause mortality and incidence of acute aortic events in both surveillance and elective ascending aortic surgery groups for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up.
Aneurysm related death
Annual growth rate in diameter of ascending aortic aneurysm in the surveillance group
Incidence of cerebrovascular accidents (CVA)
Incidence of need for elective ascending aortic aneurysm repair in the surveillance group
Non aneurysm related death
Quality of life at 1 year and 2 years for both groups
30 days from surgery
Intraoperative mortality and 30 day mortality of ascending aortic aneurysm repair
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Surveillance Arm
1 of 1
Active Control
610 Total Participants · 1 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Surveillance ArmNoIntervention Group · 1 Intervention: Surveillance Arm · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
University of CalgaryOTHER
705 Previous Clinical Trials
492,161 Total Patients Enrolled
Ottawa Heart Institute Research CorporationLead Sponsor
179 Previous Clinical Trials
87,262 Total Patients Enrolled
Munir Boodhwani, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
282 Total Patients Enrolled
Jehangir Appoo, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
182 Total Patients Enrolled
Eligibility Criteria
Age 18 - 79 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have an ascending aortic aneurysm of 5.0 cm to 5.
Patients with ascending aortic aneurysm with a diameter of 4.5 cm - 4.9 cm will be observed with serial CT, and will be considered for enrollment into the trial once the aneurysm reaches 5.
References
- Guo, Ming Hao, Jehangir J Appoo, George A Wells, Michael Chu, Maral Ouzounian, Jacqueline Fortier, and Munir Boodhwani. 2021. “Protocol for a Randomised Controlled Trial for Treatment in Thoracic Aortic Aneurysm: Surgery Versus Surveillance (TITAN: Svs)”. BMJ Open. BMJ. doi:10.1136/bmjopen-2021-052070.
- 2018. "Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03536312.
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Conditions
Cancer Related
Treatments