Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Public ClinicalTrials.gov record NCT03536312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance (TITAN:SvS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03536312
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 610 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 79 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2018
- Primary completion
- May 30, 2035
- Completion
- May 30, 2035
- Last update posted
- Sep 21, 2025
2018 – 2035
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California at San Francisco Medical Center | San Francisco | California | 94121 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Recruiting |
| Mayo Clinic | Rochester | Minnesota | 55905 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| The Valley Hospital, Inc | Ridgewood | New Jersey | 07652 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| Duke University | Durham | North Carolina | 27705 | Recruiting |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | Recruiting |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | Recruiting |
| The Trustees of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| MUSC Health University Medical Center | Charleston | South Carolina | 29425 | Recruiting |
| University of Texas Health Science Centre | Houston | Texas | 77030 | Recruiting |
| Baylor Scott & White Research Institute | Plano | Texas | 75093 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03536312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2025 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03536312 live on ClinicalTrials.gov.