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NCT05904548 · ClinicalTrials.gov registry record · NA

Atrial Flutter Ablation in the iCMR

A NA study of Atrial Flutter Typical, sponsored by Imricor Medical Systems.

Recruiting
Registry status
NA
Development phase
91
Enrollment target
6
Study locations

NCT05904548: Recruiting NA study of Atrial Flutter Typical, sponsored by Imricor Medical Systems.

NCT05904548 is a NA study of Atrial Flutter Typical that is actively recruiting participants, run by Imricor Medical Systems. The registered enrollment target is 91 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05904548, a NA study of Atrial Flutter Typical, is actively recruiting participants, sponsored by Imricor Medical Systems.

RECRUITING
Registry status
NA
Development phase
91 participants
Enrollment target
6
Study locations

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.

Primary Outcome

Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator \& irrigation pump.

Conditions Studied

Interventions

  • DEVICE RF Ablation

Study Locations (6)

Other

  • l'institut Cardiologique Paris Sud (ICPS) - Massy
  • Amsterdam University Medical Center (AUMC) - Amsterdam
  • University Hospital of Vaud (CHUV) - Lausanne

Virginia

  • University of Virginia (UVA) - Charlottesville
  • Virginia Commonwealth University - Richmond

Maryland

  • Johns Hopkins University (JHU) - Baltimore

Trial Details

FieldValue
Enrollment Target 91 participants
Start Date 2024-06-20
Est. Completion 2026-12-31
Phase NA
Imricor Medical Systems

1 total trials

What NCT05904548 shows while recruiting

NCT05904548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 1 condition, with Atrial Flutter Typical appearing as the primary indexed condition, and to 1 intervention - of which RF Ablation is the first listed.

NCT05904548 lists 6 locations in 3 states (Other, Virginia, Maryland).

Frequently Asked Questions

What is clinical trial NCT05904548 about?

NCT05904548 is a clinical study titled "Atrial Flutter Ablation in the iCMR". 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 Visio...

What is the current status of trial NCT05904548?

This trial is currently recruiting. It is a NA study. The enrollment target is 91 participants. The study started on 2024-06-20. Estimated completion is 2026-12-31.

What conditions does trial NCT05904548 study?

This clinical trial studies the following conditions: Atrial Flutter Typical.

What interventions are being tested in trial NCT05904548?

The interventions under investigation include: RF Ablation (DEVICE).

Who is sponsoring clinical trial NCT05904548?

This trial is sponsored by Imricor Medical Systems, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05904548 being conducted?

This trial has 6 study locations across Maryland, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05904548's enrollment target sits among peer trials

91 939th of 2000 higher than 1,060 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05904548, the US trial registry maintained by the National Library of Medicine. NCT05904548 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.