Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.
Eligibility criteria
Qualifiers
Subject must provide written informed consent prior to any clinical investigation-related procedure.
18 years of age or older, or the age of legal consent
CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
Able to stop anticoagulation by 90 days post index procedure
Disqualifiers
Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure
Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)
Patients with heart prosthetic valves
Patient implanted with an inferior vena cava filter
Trial design
Treatments tested in this trial
- PVI Ablation
- Left Atrial Appendage Occluder Implant
Treatment groups
240 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov