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.
This clinical investigation is intended to evaluate the safety and feasibility of Abbott's Volt™ Pulsed Field Ablation (PFA) System (Volt PFA System) and Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients with non-valvular atrial fibrillation who are indicated for both atrial fibrillation (AF) ablation and LAA occlusion (LAAO)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
PVI Ablation with Pulsed Field Ablation
Left atrial appendage occluder implant
UZ Brussel
Brussels, B CAP R, Belgium
NOT_YET_RECRUITINGMotol and Homolka University Hospital
Prague, Czech Republic, Czechia
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 vists
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 later
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rigshospitalet
Copenhagen, Copenha, Denmark
NOT_YET_RECRUITINGCardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, Germany
NOT_YET_RECRUITINGUniversitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schlesw, Germany
NOT_YET_RECRUITINGDeutsches Herzzentrum der Charite
Berlin, State of Berlin, Germany
NOT_YET_RECRUITINGMater Private Hospital
Dublin, Dublin, Ireland
NOT_YET_RECRUITINGCentro Cardiologico Monzino
Milan, Italy, Italy
RECRUITINGASST Grande Ospedale Metropolitano
Milan, Lombard, Italy
NOT_YET_RECRUITINGVilnius University Hospital Santaros Klinikos
Vilnius, Dzukija, Lithuania
NOT_YET_RECRUITING...and 3 more locations