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Atrial Flutter Ablation in the iCMR

NCT05904548 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-04-13

No results posted yet for this study

Summary

The VISABL-AFL clinical investigation is a prospective, single-arm, multi-center, interventional, Investigational Device Exemption (IDE) trial. The primary objectives of VISABL-AFL are to assess the safety and efficacy of radiofrequency (RF) ablation of type-I atrial flutter performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.

Conditions

  • Atrial Flutter Typical

Interventions

DEVICE

RF Ablation

RF ablation for type I atrial flutter under iCMR guidance

Sponsors & Collaborators

  • Imricor Medical Systems

    lead INDUSTRY

Principal Investigators

  • Kate Lindborg · Imricor Medical Systems, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • France
  • Netherlands
  • Switzerland

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 NCT05904548 on ClinicalTrials.gov