Device Related Thrombosis, Peri-device Leak
Conditions
Keywords
Watchman FLX, Left atrial appendage (LAA), Transesophageal echocardiography (TEE), Cardiac CTA
Brief summary
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure. Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone check in at 1 year.
Interventions
TEE will be performed using a 3D probe. TEE images will be acquired at the standard 0, 45, 90, and 135 degree views along with a 3D acquisition encompassing the entire LAA, device, left pulmonary vein and lateral mitral annular landmarks.
PROCEDURECardiac CTA
Cardiac CTA will be performed with ECG gating using systems with ≥ 64 detector rows and with temporal resolution that is at least 175 msec (rotation speed ≤ 350 msec for single source systems). Cardiac CTA images will be acquired for the entire cardiac cycle without ECG phase specific pulsing and with contrast appropriately timed for peak left atrial/arterial phase contrast enhancement. In addition, a targeted end systolic only delayed phase image set (45 seconds after the arterial phase scan and limited to the left atrium and appendage device) will be acquired.
Sponsors
Boston Scientific Corporation
University Hospitals Cleveland Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects \>18 years old planned to undergo LAAC * eGFR ≥ 30 mL/min per 1.73 m2
Exclusion criteria
* Subjects below the age of 18 * non-English speaking subjects * eGFR \< 30 mL/min per 1.73 m2 * Subjects with history of contrast allergy * Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE | 3 months post procedure |
| LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE. | 3 months post procedure |
| LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE. | 3 months post procedure |
| Number of detected device-related thrombus (DRT) as measured by CT scan/TEE. | 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average size of device measured in millimeters (mm) | 3 months | — |
| Number of adverse events as measured by medical record | Up to 7 days | Adverse events can include respiratory failure requiring intubation or an esophageal perforation from TEE probe insertion or serious contrast related event including anaphylaxis during the CTA or acute renal failure (ARF) requiring dialysis within 7 days of the CTA. |
| Percent of compression as measured by CT scan/TEE | 3 months | Percent compression is comprised by dividing the device diameter over the device size represented as one single score. |
| Average depth of implant measured in millimeters (mm) | 3 months | — |
| Average hypo-attenuated thickening (HAT) measured in millimeters (mm) | 3 months | — |
Countries
United States
Contacts
Primary ContactAmy McKnight, RN, BSN, BCCV
Outcome results
None listed