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Recruiting Not applicable Interventional

Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

ClinicalTrials.gov ID: NCT03536312

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.

ClinicalTrials.gov public records Last synced Sep 15, 2026, 6:01 PM EDT

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

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