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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 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. The trial reports 20 study locations across 16 states.
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
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?
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, categorized as NA. 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 10 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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