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Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)

NCT05152966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-28

Study results available
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Summary

The objective of this safety and feasibility study is to assess whether the endocardial creation of electrically nonconductive lesions via PEF catheter ablation applied using the FARAPULSE Cardiac Ablation System Plus is a feasible and safe treatment for PersAF and associated AFL

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Ablation

Ablation using the FARAPULSE™ Cardiac Ablation System Plus

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-16
Primary Completion
2022-12-01
Completion
2022-12-01
FDA Device
Yes

Countries

  • Czechia

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 NCT05152966 on ClinicalTrials.gov