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Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation

NCT05144503 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-13

No results posted yet for this study

Summary

A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.

Conditions

Interventions

DEVICE

SpherePVI™ Catheter

SpherePVI™ Catheter with the Affera Mapping and Ablation System

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    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
2021-07-22
Primary Completion
2027-03-15
Completion
2027-10-15
FDA Device
Yes

Countries

  • Lithuania

Study Locations

More Related Trials

Entities

Diseases

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 NCT05144503 on ClinicalTrials.gov