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NCT03536312 · ClinicalTrials.gov registry record · NA
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
A NA study of Ascending Aortic Aneurysm Enlargement and Ascending Aorta Aneurysm, sponsored by Ottawa Heart Institute Research Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 610
- Enrollment target
- 20
- Study locations
NCT03536312: Recruiting NA study of Ascending Aortic Aneurysm Enlargement and Ascending Aorta Aneurysm, sponsored by Ottawa Heart Institute Research Corporation.
NCT03536312 is a NA study of Ascending Aortic Aneurysm Enlargement and Ascending Aorta Aneurysm that is actively recruiting participants, run by Ottawa Heart Institute Research Corporation. The registered enrollment target is 610 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03536312, a NA study of Ascending Aortic Aneurysm Enlargement and Ascending Aorta Aneurysm, is actively recruiting participants, sponsored by Ottawa Heart Institute Research Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 610 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
At 2 years follow up, number of patients in surveillance versus treatment group suffering from mortality or acute aortic dissection
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 |
What NCT03536312 shows while recruiting
NCT03536312 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower).
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.
NCT03536312 names 20 study sites across 16 states, led by Massachusetts, Ohio, Texas.
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.
What interventions are being tested in trial NCT03536312?
The interventions under investigation include: Thoracic Aortic Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03536312?
This trial is sponsored by Ottawa Heart Institute Research Corporation, which has 10 total clinical trials registered on ClinicalTrials.gov.
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 this trial's enrollment target compares
Where NCT03536312's enrollment target sits among peer trials
610 161st of 2000 higher than 1,839 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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