NCT04800913Recruiting
The Role of Multimodality Imaging in Left Atrial Appendage Closure
Source: ClinicalTrials.gov · Last updated 22 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging. According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging. Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (PDL, device thrombi).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 4 Mar 2021
- Start date
- 8 Nov 2021
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Hungarian Institute of Cardiology
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT04800913
What you commit to
- Study type: Interventional
- Planned participants: 44
- From 8 Nov 2021 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active esophageal bleeding
- CT-contrast agent allergy
- Active infection
- Mechanical heart valve
- Open heart surgery is indicated
Lab values
- Severe chronic kidney disease (GFR\<15 ml/min/1,73 m2)
Age
- Age under 18 years
Other
- Pregnancy
- Incapacitation
- Absence of consent
- Esophageal stenosis or diverticulum
- Appendage thrombus (mobile/with significant embolic risk)
- Life expectancy shorter than 12 months
- Significant mitral valve stenosis
Who the study is looking for
- Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025
- Age above 18 years
- Informed consent
- Legal capacity
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hungarian Institute of Cardiology (Gottsegen National Cardiovascular Center) Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.