BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

NCT07181590 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-08

No results posted yet for this study

Summary

This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.

Conditions

Interventions

DEVICE

Pulsed Field Ablation

Pulsed Field Ablation using the Volt PFA System

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Sarah C Kammer · Abbott Medical Devices

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2027-08-31
Completion
2027-08-31
FDA Device
Yes

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

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 NCT07181590 on ClinicalTrials.gov