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Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Study acronym: TITAN:SvS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial sites expanded: 28 → 31 locations Show 4 more changesShow less
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Collaborators: 21 to 29
    • Publications: details revised at 2 of 2 entries
  2. Notable Primary completion date: May 31, 2025 to May 31, 2035
    • Study sites: 21 to 28
    • Study completion date: May 31, 2026 to May 31, 2035
    • Collaborators: 1 to 21
    v14
  3. Minor Site details revised at 2 of 21 sitesv13
  4. Minor Re-verified, no change to tracked fieldsv12
  5. Minor Study sites: 20 to 21v11
Show 9 earlier versionsHide 9 earlier versions
  1. Minor Site contacts updated at 1 of 20 sitesv10
  2. Minor Study sites: 7 to 20
    • Eligibility criteria expanded, about 28 words
    v9
  3. Notable Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 7 of 7 sites
    v8
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 7 of 7 sites
    v7
  5. Minor Study sites: 2 to 7v6
  6. Minor Enrollment target: 446 to 610v5
  7. Notable Lead sponsor: University of Calgary to Ottawa Heart Institute Research Corporationv4 Show 5 more changesShow less
    • Primary completion date: May 31, 2020 to May 31, 2025
    • Study completion date: May 31, 2020 to May 31, 2026
    • Start date changed from estimate of Jan 1, 2019 to Sep 1, 2018
    • Study sites revised (2)
    • Collaborator revised
  8. Notable Start date: Jul 1, 2018 to Jan 1, 2019v3
  9. Minor Site contacts updated at 1 of 2 sitesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The ascending aorta conducts blood from the heart to the rest of the body. The ascending aorta can become enlarged, and the risk of tearing and rupturing becomes higher with larger aorta. When the ascending aorta tears or ruptures, the risk dying is high even if surgery is done as soon as possible. Traditionally, when the ascending aorta gets above 5.5 cm, surgery is recommended to replace the aorta. However, this threshold is based relatively weak evidence, and sometimes patients with smaller aorta can tear or rupture. On the other hand, surgery carries its own risk as well. Since there are risk of waiting or doing surgery, there is currently no great support for either approach for patients with a smaller aorta. In the TITAN SvS trial, patients with an ascending aorta between 5.0 to 5.5 cm is assigned by chance to the early surgery group, in which they will undergo replacement of aorta, or the surveillance group, in which they will be closely monitored. The chance of dying or suffer tearing or rupture of aorta between the two groups will be compared. The result of the trial will guide future practice for patients with enlarged ascending aorta. This is a prospective, multi-centre randomized control trial that compares the all-cause mortality, aneurysm-related aortic events, rate of stroke, and quality of life for those patients undergoing early elective ascending aortic surgery to those patients undergoing surveillance. Patients referred for an ascending aortic aneurysm that meets the inclusion criteria will be randomized to the early elective surgery group or the surveillance group. Recruitment will end when the desired sample size is reached, and the patients will be followed for a minimum 2-year period. The primary objective of the trial is to compare the composite outcome of the all-cause mortality and incidence of acute aortic events between surveillance and elective ascending aortic surgery for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. The hypothesis is that the early surgery group will have a significantly lower all-cause mortality and incidence of acute aortic events at 2 years of follow up compare to the surveillance group. The result of this trial will provide evidence based guidance in the appropriate management of ascending aortic aneurysm based on the size criteria, and establish a large database for future investigations.
Trial Details
NCT Number NCT03536312
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: University of Calgary, University Health Network, Toronto, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Hamilton General Hospital, Montreal Heart Institute, University of Pennsylvania, Massachusetts General Hospital, McGill University, University of Michigan, Ohio State University, Icahn School of Medicine at Mount Sinai, Washington University School of Medicine, University Hospitals Cleveland Medical Center, University of Alberta, Mayo Clinic, Medical University of South Carolina, Nova Scotia Health Authority, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Horizon Health Network, The University of Texas Health Science Center, Houston, San Francisco Veterans Affairs Medical Center, Health Sciences North Research Institute, Baylor Scott and White Health, Duke Clinical Research Institute, Oxford Diabetes Trials Unit, The Valley Hospital, Beth Israel Deaconess Medical Center, Newfoundland Health Services, University of Iowa, Skang University Hospital
Conditions
(from sponsor)
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Related terms Aneurysm, Aneurysm, Ascending Aorta
Enrollment 610 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov