NCT03536312

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
610

participants targeted

Target at P75+ for not_applicable

Timeline
110mo left

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Sep 2018May 2035

First Submitted

Initial submission to the registry

April 18, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
16.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2035

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

16.8 years

First QC Date

April 18, 2018

Last Update Submit

September 17, 2025

Conditions

Ascending Aortic Aneurysm EnlargementAscending Aorta Aneurysm

Keywords

Ascending Aorta AneurysmAneurysmRandomized Control Trial

Outcome Measures

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

    2 years

Secondary Outcomes (7)

  • Intraoperative mortality and 30 day mortality of ascending aortic aneurysm repair

    30 days from surgery

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

    2 years

  • Non aneurysm related death

    2 years

  • Aneurysm related death

    2 years

  • Incidence of cerebrovascular accidents (CVA)

    2 years

  • +2 more secondary outcomes

Study Arms (2)

Surveillance Arm

NO INTERVENTION

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.

Surgery/Treatment Arm

OTHER

Patients in the Operative Registry will have thoracic aortic surgery

Procedure: Thoracic Aortic Surgery

Interventions

Thoracic Aortic SurgeryPROCEDURE

Thoracic aortic surgery to treat thoracic aortic aneurysm

Surgery/Treatment Arm

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Previous cardiac surgery
  • Patients whose primary indication for cardiac surgery is non-AsAA related
  • Known AsAA expansion rate exceeding 0.5 cm/year during the past 5 years
  • Arch aneurysms with no ascending aorta involvement (no aneurysmal segments before the innominate artery)
  • Ascending aortic and arch aneurysm with descending thoracic aorta involvement
  • Patients with known connective tissue disease (E.g. Marfan syndrome, Loey-Dietz syndrome, Turner syndrome etc) syndrome, etc.)
  • Patients with possible genetic aortopathies (eg known family history of aortic aneurysms/premature aortic dissections/ruptures)
  • Patients with inflammatory arteritis (e.g. takayasu's arteritis, syphilitic arteritis, etc.)
  • Female patients who are pregnant or planning to become pregnant
  • 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.
  • Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include:
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

University of California at San Francisco Medical Center

San Francisco, California, 94121, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

The Valley Hospital, Inc

Ridgewood, New Jersey, 07652, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MUSC Health University Medical Center

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas Health Science Centre

Houston, Texas, 77030, United States

RECRUITING

Baylor Scott & White Research Institute

Plano, Texas, 75093, United States

RECRUITING

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 0M9, Canada

RECRUITING

Horizon Health Network

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, B3S 0H6, Canada

RECRUITING

Health Sciences North

Greater Sudbury, Ontario, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

RECRUITING

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Toronto General Hospital

Toronto, Ontario, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, H3H2R9, Canada

RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (1)

  • Guo MH, Appoo JJ, Wells GA, Chu M, Ouzounian M, Fortier J, Boodhwani M. Protocol for a randomised controlled trial for Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS). BMJ Open. 2021 May 26;11(5):e052070. doi: 10.1136/bmjopen-2021-052070.

    PMID: 34039580DERIVED

MeSH Terms

Conditions

Aneurysm, Ascending AortaAneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm, ThoracicAortic AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Munir Boodhwani, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

  • Jehangir Appoo, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Khatira Mehdiyeva

CONTACT

613-696-7000kmehdiyeva@ottawaheart.ca

Alice Black

CONTACT

613-696-7230alblack@ottawaheart.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Patients between the age of 18 and 79 with an asymptomatic ascending aortic aneurysm between 5.0 cm and 5.4 cm in maximal diameter are entered into the randomization study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 24, 2018

Study Start

September 1, 2018

Primary Completion (Estimated)

May 31, 2035

Study Completion (Estimated)

May 31, 2035

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(15)CA(13)