Recruiting

Surgery vs. SurveillanceTreatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT03536312

Conditions

Ascending Aortic Aneurysm Enlargement

Ascending Aorta Aneurysm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Thoracic Aortic Surgery

Study Details

Brief 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.

Conditions

Ascending Aortic Aneurysm Enlargement

Ascending Aorta Aneurysm

Study ID

NCT03536312

Start date

Sep 1, 2018

Status verified date

Sep, 2025

Completion date

May 31, 2035

Anticipated

Primary completion date

May 31, 2035

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients between the age of 18 and 79 inclusive.
2. Ascending aortic aneurysm between 5.0cm and 5.4cm in maximal diameter as measured by CT with contrast.
3. 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.

Exclusion Criteria:

1. Patients who refused to be randomized
2. Patients with symptomatic attributable to ascending aortic aneurysms
3. Patients who are unable to provide informed consents
4. Patients who are unable to attend for regular follow-up/ remain compliant with protocol
5. Previous cardiac surgery
6. Patients whose primary indication for cardiac surgery is non-AsAA related
7. Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years
8. Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery)
9. Ascending aortic and arch aneurysm with descending thoracic aorta involvement
10. Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.)
11. Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
12. Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.)
13. Female patients who are pregnant or planning to become pregnant
14. Patients who have a history or presence of a medical condition or disease or psychiatric condition that in the investigator's assessment would render the subject ineligible for study participation.
15. Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include:

Severe pulmonary disease
Cr = 250umol/L
Child Pugh Class B or C
NYHA III or IV
MI within the last 6 months
Major surgical procedure or angioplasty within 3 months
Expected survival less than 5 years because of other disease (e.g. invasive cancer)

Study Design

Enrollment

610 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

Thoracic Aortic Surgery

Thoracic aortic surgery to treat thoracic aortic aneurysm

Primary outcome measure

All-cause mortality and incidence of acute aortic events in both surveillance and elective ascending aortic surgery groups for patients with degenerative or bicuspid valve-related ascending aortic aneurysm after 2 years of follow up. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Khatira Mehdiyeva

613-696-7000 kmehdiyeva@ottawaheart.ca

Alice Black

613-696-7230 alblack@ottawaheart.ca

Locations

University of California at San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94121

Principal Investigator:

Elaine Tseng, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Arminder Jassar, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jenifer Kaufman

617-632-8956 jmkaufma@bidmc.harvard.edu

Principal Investigator:

Brett Carroll, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Himanshu Patel, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Disrud Levi

507-284-2511 Disrud.Levi@mayo.edu

Principal Investigator:

Gabor Bagameri, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Allison Schuck

314-362-5000 aschuck@wustl.edu

Principal Investigator:

Puja Kachroo, MD

The Valley Hospital, Inc

Recruiting

Ridgewood, New Jersey, United States, 07652

Principal Investigator:

Juan Grau, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Ismail El-Hamamsy, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Principal Investigator:

G. Chad Hughes, MD

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Nisreen Zueiter

216-844-1000 nisreen.zueiter@UHhospitals.org

Principal Investigator:

Cristian Baeza, MD

Ohio State University Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Jovan Bovinovski, MD

The Trustees of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Nimesh Desai, MD

MUSC Health University Medical Center

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Hannah Culpepper

843-792-7244 culpepph@musc.edu

Principal Investigator:

Sanford Zeigler, MD

University of Texas Health Science Centre

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Anthony Estrera, MD

Baylor Scott & White Research Institute

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

William Brinkman, MD

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Principal Investigator:

Alexander Gregory, MD

Mazankowski Alberta Heart Institute

Recruiting

Edmonton, Alberta, Canada, T6G 0M9

Contacts

Nasim Boroumand

780-407-2667 nasim.boroumand@ahs.ca

Principal Investigator:

Michael Moon, MD

Horizon Health Network

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

Principal Investigator:

Zlatko Pozeg, MD

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3S 0H6

Contacts

Cynthia Ukeoma

902-473-2847 Cynthia.Ukeoma@nshealth.ca

Principal Investigator:

Christine Herman, MD

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada

Principal Investigator:

Rony Atoui, MD

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada

Principal Investigator:

Richard Whitlock, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Principal Investigator:

Michael Chu, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Munir Boodhwani, MD

613-696-7237 MBoodhwani@ottawaheart.ca

Azmat Sheikh

613-696-7000 AzSheikh@ottawaheart.ca

Principal Investigator:

Munir Boodhwani, MD

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada

Principal Investigator:

Maral Ouzounian, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Principal Investigator:

Philippe Demers, MD

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3H2R9

Principal Investigator:

Kevin Lachapelle, MD

Institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Principal Investigator:

François Dagenais, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

Ascending Aorta Aneurysm
Aneurysm
Randomized Control Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2025-09-22.