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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
TITAN:SvS Trial Summary
This trial is investigating whether it is better to do surgery or just monitor patients with an enlarged ascending aorta.
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.Check my eligibility
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.See study design
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.
TITAN:SvS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 79 years old.
Select...
My aortic aneurysm is between 5.0cm and 5.4cm in size.
TITAN:SvS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Aneurysm related death
Annual growth rate in diameter of ascending aortic aneurysm in the surveillance group
Incidence of cerebrovascular accidents (CVA)
+4 moreTITAN:SvS 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.
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
91,826 Total Patients Enrolled
University of CalgaryOTHER
792 Previous Clinical Trials
868,544 Total Patients Enrolled
Jehangir Appoo, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant or planning to become pregnant.I am unable to understand or sign the consent form.You have a known connective tissue disease, such as Marfan syndrome, Loey-Dietz syndrome, or Turner syndrome.My aneurysm is in the arch without affecting the ascending aorta.I have a condition where my arteries are inflamed.I have an aneurysm in my aorta that extends from the ascending part through the arch to the descending thoracic area.My family has a history of aortic aneurysms or dissections.I am considered unfit for surgery due to severe health issues.I have had heart surgery in the past.My aortic aneurysm has grown more than 0.5 cm/year in the last 5 years.I am between 18 and 79 years old.My aortic aneurysm is between 5.0cm and 5.4cm in size.My aortic aneurysm is being monitored and will be eligible for the trial once it reaches 5.0 cm.I have refused to be randomly assigned to a treatment group.I can regularly attend follow-ups and stick to the study plan.I have symptoms caused by an enlarged ascending aorta.You are having heart surgery for a reason not related to a condition called non-AsAA.
Research Study Groups:
This trial has the following groups:- Group 1: Surveillance Arm
- Group 2: Surgery/Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment include elderly individuals over the age of eighty?
"As per the eligibility requirements for this trial, suitable candidates must be aged between 18 to 79 years. In addition, there are 7 trials available for minors and 150 slots allocated for seniors above 65."
Answered by AI
Do I qualify for involvement in this trial?
"This 610-participant trial is seeking out individuals aged 18 to 79 who have an aortic aneurysm measuring between 4.5 and 5 cm in diameter upon serial CT scans. Once the aneurysm grows past 5 cm, these patients will be eligible for enrollment into the study."
Answered by AI
How many US locations are hosting this research endeavor?
"At the moment, this trial is open to participants from 21 distinct locations. For example, there are sites in Québec City and London; patients should choose the closest center to them in order to alleviate travel requirements."
Answered by AI
Is this research program presently welcoming participants?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is currently recruiting participants, with the initial post dating to September 1st 2018 and a recent update on April 26th 2022. 610 volunteers are needed from 21 different medical locations."
Answered by AI
What is the current enrollment capacity of this trial?
"Correct. According to clinicaltrials.gov, this scientific trial is still enrolling volunteers and has been since September 1st 2018. It was last edited on April 26th 2022 and requires 610 participants to be enrolled across 21 sites."
Answered by AI
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