TEE vs Cardiac CTA for Blood Clot Prevention

Not yet recruiting at 4 trial locations

Overseen By Amy McKnight, RN, BSN, BCCV

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Steven Filby, MD

Disqualifiers: Under 18, Non-English, Low eGFR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two heart imaging tests, TEE and cardiac CTA, to determine which better detects blood clots after a left atrial appendage closure (LAAC) procedure. TEE uses a probe in the esophagus to perform a heart ultrasound, while cardiac CTA employs x-rays and dye to create heart images. Individuals who have undergone an LAAC procedure and have normal kidney function may qualify for this trial. Participants will undergo both tests on the same day, 90 days after the procedure, to help researchers identify the most comfortable and effective method for patients. As an unphased trial, this study allows participants to contribute to the advancement of heart imaging techniques for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these imaging techniques are safe for patients undergoing LAAC?

Research has shown that the Watchman FLX device, used in a heart procedure called left atrial appendage occlusion (LAAC), is generally safe for patients. In a large study with over 97,000 patients, only 0.45% experienced significant safety issues related to the device or procedure. After one year, the Watchman FLX was associated with a lower risk of major problems, such as serious complications or strokes.

These results suggest that the Watchman FLX is well-tolerated and has a strong safety record. This information is important for anyone considering participation in a clinical trial with this device, as it indicates a low chance of serious side effects or complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing Cardiac CTA and Transesophageal echocardiography (TEE) for blood clot prevention because these methods might offer new insights into heart health. Unlike traditional methods, Cardiac CTA is non-invasive and uses advanced imaging to provide detailed pictures of the heart and blood vessels, potentially improving the detection of clots without the need for more invasive procedures. TEE, on the other hand, is already known for its ability to provide close-up images of the heart, but it involves inserting a probe into the esophagus, which can be uncomfortable for some patients. By comparing these techniques, researchers hope to find out which is more effective and comfortable for patients, which could lead to better prevention of blood clots with fewer side effects.

What evidence suggests that this trial's imaging techniques could be effective for blood clot prevention?

This trial will compare the effectiveness of transesophageal echocardiography (TEE) and cardiac computerized tomography angiography (CTA) for blood clot prevention. Research has shown that TEE effectively finds blood clots, especially in the left atrial appendage, a common spot for clots. This method significantly impacts patient care, aiding doctors in making better treatment decisions for about 24% of patients tested. In contrast, cardiac CTA is a precise, non-invasive test that uses x-rays to create detailed images of the heart. It effectively detects heart-related blood clots and can help reduce hospital costs and the length of hospital stays. Both TEE and cardiac CTA are valuable tools for identifying blood clots, although they operate in slightly different ways. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven Filby, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for patients who have had a procedure to close off a part of the heart called the left atrial appendage. They must be able to undergo both an ultrasound of the heart via the esophagus and a special type of X-ray imaging using contrast dye, scheduled for 90 days after their procedure.

Inclusion Criteria

My kidney function is at a safe level for the trial.

Exclusion Criteria

Non-English speaking subjects

Subjects with history of contrast allergy

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo both TEE and cardiac CTA 90 days after their LAAC procedure

3 months

1 visit (in-person)

Follow-up

Participants have a routine follow-up visit and a brief phone check-in at 1 year

1 year

1 visit (in-person), 1 visit (phone)

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac CTA
• Transesophageal echocardiography (TEE)

Trial Overview The study compares two types of heart imaging: transesophageal echocardiography (TEE), which involves an ultrasound probe in the esophagus, and cardiac CTA, a non-invasive X-ray with contrast dye. Both tests are done on day 90 post-procedure.

How Is the Trial Designed?

Group I: Left Atrial Appendage Occlusion (LAAC) with Watchman FLX. Experimental Treatment 2 Interventions

Patients who are status post LAAC using the Watchman FLX.

Who Is Running the Clinical Trial?

Steven Filby, MD

Lead Sponsor

Trials

1

Recruited

320+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8802838/

Cardiac CT angiography in current practice - PubMed Central CCTA offers several advantages beyond other testing modalities, due to its ability to identify and characterize coronary stenosis severity and ...

2. journalofcardiovascularct.com journalofcardiovascularct.com/article/S1934-5925(22)00278-7/fulltext

2022 use of coronary computed tomographic angiography ... Coronary CTA was associated with 20% reduction in hospital costs, and a 34% reduction in length-of-stay (13.5 hrs vs 20.7 hrs, p ​< ​0.0001).

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.122.041018

Results From the ENCLOSE Study | Stroke Extending the stroke CTA to cover the heart increases the chance of detecting cardiac thrombi and helps to identify cardioembolic sources in the acute stage of ...

4. cleerlyhealth.com cleerlyhealth.com/blog/benefits-of-cardiac-ct-angiogram-as-diagnostic-tool

The Benefits of Cardiac CT Angiogram as a Diagnostic Tool Cardiologists use cardiac computed tomography angiogram (CCTA) as an accurate, non-invasive tool for diagnosing and treating coronary artery ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666084925007764

The Importance of CT Angiography in Detecting Impending ... CTA is a useful imaging modality for detecting IPDE even when transthoracic echocardiography cannot detect it.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.123.013750

Outcomes With the WATCHMAN FLX in Everyday Clinical ... Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39056187/

Outcomes With the WATCHMAN FLX in Everyday Clinical ... The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke ...

8. watchman.com watchman.com/en-us-implanter/clinical-evidence.html

Clinical Evidence - Studies and Trials - WATCHMAN FLX The OPTION clinical trial is the first randomized, head-to-head study comparing left atrial appendage closure (LAAC) to oral anticoagulants (OACs)—95% of ...

9. jacc.org jacc.org/doi/abs/10.1016/j.jcin.2025.03.025

Left Atrial Appendage Occlusion With Watchman FLX At 1 year, Watchman FLX was associated with a significantly lower risk for major adverse events (adjusted HR: 0.84; 95% CI: 0.80-0.88; P < 0.0001), ischemic ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S247487062400109X

Left Atrial Appendage Occlusion: Expanding Indications ... Safety was excellent, with only 0.37% of patients experiencing a device or procedure-related event (all-cause death, stroke/SE, device/procedure complication) ...