Testing Thoracic Aortic Surgery for ascending aortic aneurysm enlargement
Official title: Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance (TITAN:SvS)
- 2 groups
- Sites in Calgary, Edmonton and 9 more cities
- Recruiting
Interventions
- Medical procedure
Thoracic Aortic Surgery
Thoracic aortic surgery to treat thoracic aortic aneurysm
Canadian Sites (13)
12 of 13 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta
- Recruiting
Horizon Health Network
Saint John, New Brunswick
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia
- Recruiting
Health Sciences North
Greater Sudbury, Ontario
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Recruiting
Toronto General Hospital
Toronto, Ontario
- Recruiting
Montreal Heart Institute
Montreal, Quebec
- Recruiting
McGill University Health Centre
Montreal, Quebec
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for25 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → into the trial once the aneurysm reaches 5.0 cm.
Exclusion
- −Patients who refused to be randomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
- −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-upFollow-upContinued check-ins after the treatment part is finished.Read more →/ remain compliant with protocolProtocolThe detailed plan a study must follow.Read more →
- −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.)
- −Patients who have a history or presence of a medical condition or disease or psychiatric condition that in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s assessment would render the subject ineligible for study participation.
- −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)
- −Female patients who are pregnant or planning to become pregnant
- −Previous cardiac surgery
- −Patients whose primary indication for cardiac surgery is non-AsAA related
- −Patients who, in the opinion of the investigator, are deemed unfit for surgery for reasons that may include:
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study does not fall into the standard research categories.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives no study treatment and is followed for comparison.
Registry label: A: Surveillance Arm
Group B receives Thoracic Aortic Surgery.
Registry label: B: Surgery/Treatment Arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 79 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 610 people.
The study is currently expected to finish around May 2035.
The main measurement is taken over: 2 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study 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 upFollow-upContinued check-ins after the treatment part is finished.Read more → — measured over 2 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT03536312 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Thoracic Aortic SurgeryProcedure
Thoracic aortic surgery to treat thoracic aortic aneurysm
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 79 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 79 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 2 years.
The study as a whole is currently expected to finish around 2035-05-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 610 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Saint John, New Brunswick, Canada; Halifax, Nova Scotia, Canada; Greater Sudbury, Ontario, Canada; Hamilton, Ontario, Canada, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (3)
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.