Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
NCT03536312 · View on ClinicalTrials.gov ↗
Study Summary
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 a
Conditions Studied
Interventions
- PROCEDURE Thoracic Aortic Surgery
Study Locations (20)
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Medical Center — Boston
Ohio
- University Hospitals Cleveland — Cleveland
- Ohio State University Medical Center — Columbus
Texas
- University of Texas Health Science Centre — Houston
- Baylor Scott & White Research Institute — Plano
Alberta
- University of Calgary — Calgary
- Mazankowski Alberta Heart Institute — Edmonton
California
- University of California at San Francisco Medical Center — San Francisco
Michigan
- University of Michigan — Ann Arbor
Minnesota
- Mayo Clinic — Rochester
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2035-05-31 |
| Phase | NA |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03536312
The ClinicalTrials.gov registry entry for NCT03536312 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ottawa Heart Institute Research Corporation, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Ascending Aortic Aneurysm Enlargement appearing as the primary indexed condition, and to 1 intervention — of which Thoracic Aortic Surgery is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03536312 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Massachusetts, Ohio, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03536312 about?
NCT03536312 is a clinical study titled "Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance". 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. ...
What is the current status of trial NCT03536312?
This trial is currently recruiting. It is a NA study. The enrollment target is 610 participants. The study started on 2018-09-01. Estimated completion is 2035-05-31.
What conditions does trial NCT03536312 study?
This clinical trial studies the following conditions: Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03536312?
The interventions under investigation include: Thoracic Aortic Surgery (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03536312?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03536312 being conducted?
This trial has 20 study locations across California, Massachusetts, Michigan, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.