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.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me