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Comparing surgery and monitoring for ascending aortic aneurysms

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

Not applicable Interventional Ottawa Heart Institute Research Corporation · NCT03536312

This study tests whether early surgery or careful monitoring is better for people aged 18 to 79 with asymptomatic ascending aortic aneurysms that are between 5.0 cm and 5.4 cm.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment610 (estimated)
Ages18 Years to 79 Years
SexAll
SponsorOttawa Heart Institute Research Corporation Academic / other
Locations28 sites (San Francisco, California and 27 other locations)
Trial IDNCT03536312 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of early surgical intervention versus surveillance in patients with asymptomatic ascending aortic aneurysms measuring between 5.0 cm and 5.4 cm. Patients aged 18 to 79 will be randomly assigned to either undergo surgery or be closely monitored. The study aims to gather data on patient outcomes, including the risk of aneurysm rupture and overall survival rates. Comprehensive baseline assessments will be conducted, including imaging and quality of life evaluations, to ensure appropriate patient selection and monitoring.

Who should consider this trial

Good fit: Ideal candidates are asymptomatic patients aged 18 to 79 with an ascending aortic aneurysm measuring between 5.0 cm and 5.4 cm.

Not a fit: Patients with symptomatic ascending aortic aneurysms or those unable to comply with follow-up may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide clearer guidelines for managing ascending aortic aneurysms, potentially reducing unnecessary surgeries and improving patient outcomes.

How similar studies have performed: While there have been studies on surgical intervention for aortic aneurysms, this specific randomized approach comparing surgery to surveillance in this size range is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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)

Where this trial is running

San Francisco, California and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ascending Aortic Aneurysm EnlargementAscending Aorta AneurysmAneurysmRandomized Control Trial
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.