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NCT03536312From ClinicalTrials.govRecruiting

Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance (TITAN:SvS)

  • Ascending Aortic Aneurysm Enlargement
  • Ascending Aorta Aneurysm

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Ottawa Heart Institute Research Corporation
Enrolment target
610
Started
1 September 2018
Main results due
31 May 2035
Study sites
31
Registry updated
28 September 2026

Can you take part?

  • Ages 18 years to 79 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

1. Patients between the age of 18 and 79 inclusive.
2. Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast.
3. 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 5.0 cm.

Exclusion Criteria:

1. Patients who refused to be randomized
2. Patients with symptomatic attributable to ascending aortic aneurysms
3. Patients who are unable to provide informed consents
4. Patients who are unable to attend for regular follow-up/ remain compliant with protocol
5. Previous cardiac surgery
6. Patients whose primary indication for cardiac surgery is non-AsAA related
7. Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years
8. Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery)
9. Ascending aortic and arch aneurysm with descending thoracic aorta involvement
10. Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.)
11. Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
12. Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.)
13. Female patients who are pregnant or planning to become pregnant
14. Patients who have a history or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would render the subject ineligible for study participation.
15. Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include:

    * Severe pulmonary disease
    * Cr = 250umol/L
    * Child Pugh Class B or C
    * NYHA III or IV
    * MI within the last 6 months
    * Major surgical procedure or angioplasty within 3 months
    * Expected survival less than 5 years because of other disease (e.g. invasive cancer)

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(31)

  • University of California at San Francisco Medical Center

    San Francisco, California, United States

    Recruiting

  • University of Iowa

    Iowa City, Iowa, United States

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

    Recruiting

  • University of Michigan

    Ann Arbor, Michigan, United States

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, United States

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, United States

    Recruiting

  • The Valley Hospital, Inc

    Ridgewood, New Jersey, United States

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, United States

    Recruiting

  • Duke University

    Durham, North Carolina, United States

    Recruiting

  • University Hospitals Cleveland

    Cleveland, Ohio, United States

    Recruiting

  • Ohio State University Medical Center

    Columbus, Ohio, United States

    Recruiting

  • The Trustees of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States

    Recruiting

  • MUSC Health University Medical Center

    Charleston, South Carolina, United States

    Recruiting

  • University of Texas Health Science Centre

    Houston, Texas, United States

    Recruiting

  • Baylor Scott & White Research Institute

    Plano, Texas, United States

    Recruiting

  • University of Calgary

    Calgary, Alberta, Canada

    Active, not recruiting

  • Mazankowski Alberta Heart Institute

    Edmonton, Alberta, Canada

    Recruiting

  • Horizon Health Network

    Saint John, New Brunswick, Canada

    Recruiting

  • Newfoundland Health Services

    St. John's, Newfoundland and Labrador, Canada

    Recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, Canada

    Recruiting

  • Health Sciences North

    Greater Sudbury, Ontario, Canada

    Recruiting

  • Hamilton General Hospital

    Hamilton, Ontario, Canada

    Active, not recruiting

  • London Health Sciences Centre

    London, Ontario, Canada

    Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario, Canada

    Recruiting

  • St. Michael's Hospital

    Toronto, Ontario, Canada

    Not yet recruiting

  • Toronto General Hospital

    Toronto, Ontario, Canada

    Recruiting

  • Montreal Heart Institute

    Montreal, Quebec, Canada

    Recruiting

  • McGill University Health Centre

    Montreal, Quebec, Canada

    Recruiting

  • Institut universitaire de cardiologie et de pneumologie de Québec

    Québec, Quebec, Canada

    Recruiting

  • Skåne University Hospital

    Malmö, Skåne County, Sweden

    Recruiting

Showing 31 of 31 sites. 28 of the 31 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT03536312. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance | Trialion