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Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

RecruitingNAAges 18 Years - 79 YearsAllOttawa Heart Institute Research Corporation
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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)
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What it tests

  • Thoracic Aortic Surgery
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Where

31 sites
University of California at San Francisco Medical Center
San Francisco, United States
University of Iowa
Iowa City, United States
Massachusetts General Hospital
Boston, United States
Beth Israel Deaconess Medical Center
Boston, United States
University of Michigan
Ann Arbor, United States
Mayo Clinic
Rochester, United States
Washington University School of Medicine
St Louis, United States
The Valley Hospital, Inc
Ridgewood, United States

โ€ฆand 23 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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