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Procedure

Surgery vs Surveillance for Thoracic Aortic Aneurysm (TITAN:SvS Trial)

N/A
Recruiting
Led By Jehangir Appoo, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Female patients who are pregnant or planning to become pregnant
Patients who are unable to provide informed consents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares early surgery to close monitoring for adults with a slightly enlarged main artery from the heart. The goal is to see which approach better prevents serious complications like tearing or rupture.

Who is the study for?
This trial is for adults aged 18-79 with an ascending aortic aneurysm measuring between 5.0 and 5.4 cm, who can provide informed consent and commit to follow-up. It excludes those unfit for surgery, with certain medical conditions or previous cardiac surgeries, pregnant women, or those with rapid aneurysm growth.
What is being tested?
The TITAN SvS trial randomly assigns patients to either early elective surgery to replace the enlarged part of the aorta or close monitoring (surveillance). The goal is to see which approach better reduces death and aortic tearing/rupture after two years.
What are the potential side effects?
Potential side effects from early elective thoracic aortic surgery may include risks associated with anesthesia, bleeding, infection, stroke, damage to surrounding organs or tissues, and prolonged recovery time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 79 years old.
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My aortic aneurysm is between 5.0cm and 5.4cm in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am pregnant or planning to become pregnant.
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I am unable to understand or sign the consent form.
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My aneurysm is in the arch without affecting the ascending aorta.
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I have a condition where my arteries are inflamed.
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I have an aneurysm in my aorta that extends from the ascending part through the arch to the descending thoracic area.
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I have had heart surgery in the past.
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My aortic aneurysm has grown more than 0.5 cm/year in the last 5 years.
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I have refused to be randomly assigned to a treatment group.
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I can regularly attend follow-ups and stick to the study plan.
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I have symptoms caused by an enlarged ascending aorta.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
Secondary study objectives
Aneurysm related death
Annual growth rate in diameter of ascending aortic aneurysm in the surveillance group
Incidence of cerebrovascular accidents (CVA)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Surgery/Treatment ArmExperimental Treatment1 Intervention
Patients in the Operative Registry will have thoracic aortic surgery
Group II: Surveillance ArmActive Control1 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatment for Ascending Aortic Aneurysm is early elective ascending aortic surgery, which involves the prophylactic replacement of the enlarged section of the aorta. This surgical intervention aims to prevent the aorta from tearing or rupturing, which can be life-threatening. By replacing the weakened portion of the aorta before it reaches a critical size, the risk of catastrophic events such as aortic dissection or rupture is significantly reduced. This is particularly important for patients with ascending aortic aneurysms, as the condition can progress silently and rapidly, leading to sudden and severe complications. Early surgical intervention provides a proactive approach to managing the aneurysm, improving patient outcomes and survival rates.
Outcome of reoperative aortic root or ascending aorta replacement after prior aortic valve replacement.

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
194 Previous Clinical Trials
92,402 Total Patients Enrolled
University of CalgaryOTHER
806 Previous Clinical Trials
883,306 Total Patients Enrolled
Jehangir Appoo, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
182 Total Patients Enrolled

Media Library

Thoracic Aortic Surgery (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03536312 — N/A
Ascending Aortic Aneurysm Research Study Groups: Surveillance Arm, Surgery/Treatment Arm
Ascending Aortic Aneurysm Clinical Trial 2023: Thoracic Aortic Surgery Highlights & Side Effects. Trial Name: NCT03536312 — N/A
Thoracic Aortic Surgery (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03536312 — N/A
~53 spots leftby May 2025