Assessing long-term outcomes of LAA contrast flow after heart procedure
Long-Term Outcomes of Left Atrial Appendage Contrast Flow in CT Scans After Endocardial LAA Closure: The CF-CT Registry
This study looks at how well heart devices used to close the left atrial appendage work over time in patients, especially those at high risk, to see if they prevent leaks, blood clots, and strokes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kansas City Heart Rhythm Research Foundation Academic / other |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT06075628 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the long-term outcomes of left atrial appendage (LAA) contrast flow in patients who have undergone LAA closure using FDA-approved devices. It will involve a retrospective review of approximately 100 patient charts to investigate the incidence of peri-device leaks, device-related thrombosis, and the occurrence of strokes or transient ischemic attacks. The study seeks to understand the correlation between LAA contrast flow and the effectiveness of the closure devices over time, particularly in high-risk patients transitioning from anticoagulation to antiplatelet therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone LAA closure with either the Watchman/Watchman FLX or Amplatzer Amulet devices between January 2019 and June 2022.
Not a fit: Patients who have not undergone LAA closure with the specified devices or those under 18 years of age may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the long-term safety and effectiveness of LAA closure devices, potentially improving patient outcomes in atrial fibrillation management.
How similar studies have performed: This study is novel as there are currently no existing studies or registries focusing on the long-term follow-up of left atrial appendage contrast flow.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must be at least 18 years of age. * Subjects underwent LAA closure with Watchman/Watchman FLX or Amplatzer Amulet at our institution from January 2019 till June 2022 Exclusion Criteria: * No definite exclusion criteria are defined for the study as all patients with Watchman-FLX or Amplatzer Amulet will be included in the study.
Where this trial is running
Overland Park, Kansas
- Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Dhanunjaya Lakkireddy, MD — Kansas City Heart Rhythm Institute
- Study coordinator: Donita Atkins
- Email: datkins@kchrf.com
- Phone: 816-651-1969
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.