Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration

NCT07523620 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-27

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Fibrillation (AF)
  • Paroxysmal AF
  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

PVI Ablation

PVI Ablation with Pulsed Field Ablation

DEVICE

Left Atrial Appendage Occluder Implant

Left atrial appendage occluder implant

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-05-31
Completion
2028-02-28
FDA Device
Yes

Countries

  • Belgium
  • Czechia
  • Denmark
  • Germany
  • Ireland
  • Italy
  • Lithuania
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07523620 on ClinicalTrials.gov