Last updated: March 9, 2021
Sponsor: R&D Cardiologie
Overall Status: Active - Recruiting
Phase
N/A
Condition
Chest Pain
Atrial Fibrillation
Dysrhythmia
Treatment
N/AClinical Study ID
NCT04705688
RDC-2020.02
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subject is aged 18 years or older
- The subject is accepted/scheduled for left atrial appendage occlusion
- The subject has a CHA₂DS₂-VASc Score ≥2 (male) or ≥3 (female)
- The subject or legal representative is able to understand and is willing to providewritten informed consent to participate in the trial.
Exclusion
Exclusion Criteria:
- Unable or unwilling to return for required follow-up visits and examinations
- Mechanical heart valves or valvular disease requiring surgery or interventionalprocedure
- Ongoing major bleeding or complicated or recent (<72hours) major surgery
- Known large oesophageal varices or decompensated liver disease (unless a documentedpositive opinion of a gastro-enterologist)
- Severe thrombocytopenia (<50,000/ml)
- High likelihood of being unavailable for follow-up or psycho-social condition makingstudy participation impractical.
- Woman with child bearing potential who do not use an efficient method ofcontraception.
- Positive serum or urine pregnancy test for woman with child bearing potential
- Pregnancy or within 48 hours post-partum
- unsuitable LAA anatomy for occlusion or thrombus in the LAA at the time of procedure
- contraindications or unfavourable conditions to perform cardiac catheterization ortransesophageal echocardiography (TEE)
- atrial septal malformations, atrial septal defect or a high-risk patent foramen ovalethat may cause thrombo-embolic events
- atrial septal defect repair or closure device or a patent foramen ovale repair or anyother anatomical condition as this may preclude an LAAO procedure
- Mitral valve regurgitation grade 3 or more
- Aortic valve stenosis (AVA<1.0 cm2 or Pmax>50 mmHg) or regurgitation grade 3 or more
- Planned carotid endarterectomy (CEA) for significant carotid artery disease
- Life expectancy of less than 1 year
Study Design
Total Participants: 120
Study Start date:
February 24, 2021
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
St. Antonius Ziekenhuis
Nieuwegein, Utrecht 3430 EM
NetherlandsActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.