Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorOttawa Heart Institute Research Corporation

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who refused to be randomized

Patients with symptomatic attributable to ascending aortic aneurysms

Patients who are unable to provide informed consents

Patients who are unable to attend for regular follow-up/ remain compliant with protocol

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thoracic Aortic Surgery

    Procedure/Surgery

    Thoracic aortic surgery to treat thoracic aortic aneurysm

Treatment groups

610 Participants
are divided into 2 treatment groups
Group A: Surveillance ArmNo intervention 0 interventions
Group B: Surgery/Treatment ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

At 2 years follow up, number of patients in surveillance versus treatment group suffering from mortality or acute aortic dissection

Time frame
2 years

Secondary outcomes

1

Intraoperative mortality and 30 day mortality of ascending aortic aneurysm repair

Document death during surgery or within 30 days post surgery

Time frame
30 days from surgery
2

Incidence of need for elective ascending aortic aneurysm repair in the surveillance group

How many patients on the surveillance arm of the trial need to have surgery prior to the end of trial surveillance

Time frame
2 years
3

Non aneurysm related death

How many patients in either surgical or surveillance arm have a non aneurysm related death

Time frame
2 years
4

Aneurysm related death

How many patients in either the surveillance or surgical arm have an aneurysm related death

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

University of Calgary

Collaborator

University Health Network, Toronto

Collaborator

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator

Hamilton General Hospital

Collaborator

Montreal Heart Institute

Collaborator

University of Pennsylvania

Collaborator

Massachusetts General Hospital

Collaborator

McGill University

Collaborator

University of Michigan

Collaborator

Ohio State University

Collaborator

Icahn School of Medicine at Mount Sinai

Collaborator

Washington University School of Medicine

Collaborator

University Hospitals Cleveland Medical Center

Collaborator

University of Alberta

Collaborator

Mayo Clinic

Collaborator

Medical University of South Carolina

Collaborator

Nova Scotia Health Authority

Collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Horizon Health Network

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

San Francisco Veterans Affairs Medical Center

Collaborator

Health Sciences North Research Institute

Collaborator

Baylor Scott and White Health

Collaborator

Duke Clinical Research Institute, Oxford Diabetes Trials Unit

Collaborator

The Valley Hospital

Collaborator

Beth Israel Deaconess Medical Center

Collaborator

Newfoundland Health Services

Collaborator

University of Iowa

Collaborator

Skang University Hospital

Collaborator