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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PVI Ablation
Procedure/SurgeryPVI Ablation with Pulsed Field Ablation
Left Atrial Appendage Occluder Implant
DeviceLeft atrial appendage occluder implant
Treatment groups
240 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
LAA occlusion success determined by peri-device flow ≤5mm
The primary effectiveness outcome is LAA occlusion defined as no peri-device flow or peri-device flow ≤5mm based on Doppler color flow TEE/TOE at the 3-month follow-up visit as assessed by an independent core laboratory
Time frame
From treatment through 3-month follow-up vists2
Occurrence of specific adverse events between time of implant and 7 days post-procedure or hospital discharge, whichever was later
The primary safety outcome is defined as occurrence of one of the following between the time of implant and ≤7 days post-procedure or hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device/procedure related complications requiring open cardiac surgery or major endovascular intervention * Includes pseudoaneurysm repair or AV fistula repair * Excludes percutaneous drainage of PE, snaring of embolized devices, thrombin injection or nonsurgical treatment of access site complications
Time frame
From implant of LAAO through ≤7 days post-procedure or hospital discharge, whichever is laterSponsors and contacts
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Source ClinicalTrials.gov