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Taking people in SwedenNo phase

Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Key facts

Who runs it
Ottawa Heart Institute Research Corporation
Where
Malmö, SwedenSee the siteAlso in 2 other countries, 30 sites
Trial code
Status
Recruiting
People taking part
610 people, planned
Started
1 Sept 2018
Expected to end
31 May 2035
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Thoracic Aortic Surgery
Record updated
2 November 2026

Who can take part

Age
18 years to 79 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

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

Who cannot take part

  • Previous cardiac surgery
  • Patients whose primary indication for cardiac surgery is non-AsAA related
  • Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.)
  • Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
  • 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
  • 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)
  • Patients who refused to be randomized
  • Patients with symptomatic attributable to ascending aortic aneurysms
  • Patients who are unable to provide informed consents
  • Patients who are unable to attend for regular follow-up/ remain compliant with protocol
  • Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years
  • Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery)
  • Ascending aortic and arch aneurysm with descending thoracic aorta involvement
  • Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.)
  • Female patients who are pregnant or planning to become pregnant

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 79 years old?

Where in Sweden

Also in 2 other countries, 30 sites

  • Skåne University HospitalMalmö, SwedenContact: Louise ThelausTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Surveillance ArmNo study treatment, for comparison

    Patients in the Non-Operative Registry will be followed in clinic annually with a CT scan to monitor the status of their ascending aortic aneurysm, until the end of the study, the occurrence of an aortic event, or death.

  • Surgery/Treatment ArmOther group

    Patients in the Operative Registry will have thoracic aortic surgery

    Treatment: Thoracic Aortic Surgery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance (TITAN:SvS)
Fit questions
Built from NCT03536312, who can take part
Record updated
2 November 2026