Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance (TITAN:SvS)

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• Patients between the age of 18 and 79 inclusive.

• Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast.

• Patients with ascending aortic aneurysm with a diameter of 4.5 cm - 4.9 cm will be observed with serial CT, and will be considered for enrollment into the trial once the aneurysm reaches 5.0 cm.

Locations
United States
California
University of California at San Francisco Medical Center
RECRUITING
San Francisco
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
New Jersey
The Valley Hospital, Inc
RECRUITING
Ridgewood
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Ohio
University Hospitals Cleveland
RECRUITING
Cleveland
Ohio State University Medical Center
RECRUITING
Columbus
Pennsylvania
The Trustees of the University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
MUSC Health University Medical Center
RECRUITING
Charleston
Texas
University of Texas Health Science Centre
RECRUITING
Houston
Baylor Scott & White Research Institute
RECRUITING
Plano
Other Locations
Canada
University of Calgary
RECRUITING
Calgary
Mazankowski Alberta Heart Institute
RECRUITING
Edmonton
Health Sciences North
RECRUITING
Greater Sudbury
Nova Scotia Health Authority
RECRUITING
Halifax
Hamilton General Hospital
RECRUITING
Hamilton
London Health Sciences Centre
RECRUITING
London
McGill University Health Centre
RECRUITING
Montreal
Montreal Heart Institute
RECRUITING
Montreal
University of Ottawa Heart Institute
RECRUITING
Ottawa
Institut universitaire de cardiologie et de pneumologie de Québec
RECRUITING
Québec
Horizon Health Network
RECRUITING
Saint John
St. Michael's Hospital
NOT_YET_RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
Contact Information
Primary
Khatira Mehdiyeva
kmehdiyeva@ottawaheart.ca
613-696-7000
Backup
Alice Black
alblack@ottawaheart.ca
613-696-7230
Time Frame
Start Date: 2018-09-01
Estimated Completion Date: 2035-05-31
Participants
Target number of participants: 610
Treatments
No_intervention: Surveillance Arm
Patients in the Non-Operative Registry will be followed in clinic annually with a CT scan to monitor the status of their ascending aortic aneurysm, until the end of the study, the occurrence of an aortic event, or death.
Other: Surgery/Treatment Arm
Patients in the Operative Registry will have thoracic aortic surgery
Related Therapeutic Areas
Sponsors
Collaborators: Mayo Clinic, San Francisco Veterans Affairs Medical Center, Medical University of South Carolina, Washington University School of Medicine, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Icahn School of Medicine at Mount Sinai, University of Michigan, Hamilton General Hospital, Massachusetts General Hospital, University of Calgary, McGill, University Health Network, Toronto, University Hospitals Cleveland Medical Center, Nova Scotia Health Authority, Horizon Health Network, University of Pennsylvania, The University of Texas Health Science Center, Houston, University of Alberta, Montreal Heart Institute, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, Ohio State University
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov

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