What side effects are associated with this type of intervention?

The most common treatment for Ascending Aortic Aneurysm, particularly prophylactic replacement of the ascending aorta, carries several potential side effects and risks. These include bleeding, infection, and complications related to anesthesia. There is also a risk of stroke, heart attack, and kidney failure. Postoperative complications can include arrhythmias, graft leakage, and issues related to wound healing. Despite these risks, the procedure is often recommended to prevent the life-threatening consequences of aortic rupture or dissection.

What prior FDA approvals exist?

The FDA has approved various surgical interventions for the treatment of ascending aortic aneurysms, primarily focusing on the prophylactic replacement of the ascending aorta to prevent rupture or tearing. These surgical treatments are similar to those being studied in the Early Elective Ascending Aortic Surgery trial. While specific drugs for the direct treatment of ascending aortic aneurysms are not typically highlighted, medications such as beta-blockers and angiotensin II receptor blockers (e.g., losartan) are often used to manage associated conditions like hypertension, which can contribute to aneurysm progression.

What other types of research exist?

Promising novel alternatives to early elective ascending aortic surgery for ascending aortic aneurysm patients include: 1) Enhanced surveillance protocols using advanced imaging techniques like 4D flow MRI to monitor aneurysm progression more accurately. 2) Pharmacological interventions such as beta-blockers, angiotensin receptor blockers (ARBs), and statins to manage blood pressure and reduce aortic wall stress. 3) Endovascular stent-grafting, which is less invasive than open surgery and can be used in select cases to reinforce the aortic wall. 4) Genetic and molecular therapies targeting the underlying causes of aortic aneurysm formation, which are currently under investigation in clinical trials.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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.

0 / 12Eligibility criteria met

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.