NCT05904548

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
4 countries

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jun 2024Dec 2026

First Submitted

Initial submission to the registry

April 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

April 13, 2023

Last Update Submit

April 8, 2026

Conditions

Atrial Flutter Typical

Keywords

RF Ablationinterventional Cardiac Magnetic Resonance (iCMR)

Outcome Measures

Primary Outcomes (2)

  • Primary Efficacy Endpoint: Bi-directional block confirmation

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

    Time of procedure, following delivery of last ablation energy delivery point

  • Primary Safety Endpoint: Composite of serious cardiovascular adverse events

    A composite of the following serious adverse events as adjudicated by an independent clinical events committee: * Cardiac perforation/tamponade * Cerebrovascular accident (CVA) * Transient ischemic attack (TIA) * Complete heart block * Myocardial infarction * Pulmonary embolism * MR-related serious adverse events * Unanticipated device related serious adverse events * Death

    7-days post procedure

Secondary Outcomes (2)

  • Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days

    3 months (90 days)

  • Chronic Safety Endpoint: all serious adverse event rate for duration of study

    3 months (90 days)

Study Arms (1)

Vision-MR Atrial Flutter Ablation

EXPERIMENTAL

Type 1 Atrial Flutter ablation performed in the iCMR with the Vision-MR Ablation Catheter 2.0 and associated Advantage-MR EP recorder and stimulator system.

Device: RF Ablation

Interventions

RF AblationDEVICE

RF ablation for type I atrial flutter under iCMR guidance

Vision-MR Atrial Flutter Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient indicated for type I atrial flutter ablations with at least 1 documented episode of type I atrial flutter within 6 months (180 days) of enrollment
  • Patient 18 years and older

You may not qualify if:

  • Contraindications for MRI procedures
  • Patients who cannot have anti-arrhythmic drugs (class I or class III) prescribed for the treatment of type I atrial flutter stopped on the day of the procedure
  • Previous CTI ablation procedures
  • Myocardial infarction within 60 days of enrollment
  • Current unstable angina
  • Cardiac surgery within 90 days of enrollment
  • Any cerebral ischemic event (including transient ischemic attacks) within 6 months (180 days) of enrollment
  • Thrombocytosis or thrombocytopenia
  • Contraindication to anticoagulation therapy
  • Currently documented intracardiac thrombus or myxoma
  • Implantation of permanent leads of an implantable device in or through the right atrium within 90 days of enrollment
  • Prosthetic valve through which the catheter must pass
  • Interatrial baffle or patch through which the catheter must pass
  • Moderate or severe tricuspid valve regurgitation or stenosis
  • Uncompensated congestive heart failure
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Johns Hopkins University (JHU)

Baltimore, Maryland, 21218, United States

RECRUITING

University of Virginia (UVA)

Charlottesville, Virginia, 22903, United States

NOT YET RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

NOT YET RECRUITING

l'institut Cardiologique Paris Sud (ICPS)

Massy, 91300, France

RECRUITING

Amsterdam University Medical Center (AUMC)

Amsterdam, Netherlands

RECRUITING

University Hospital of Vaud (CHUV)

Lausanne, 1011, Switzerland

RECRUITING

Study Officials

  • Kate Lindborg

    Imricor Medical Systems, Inc.

    STUDY DIRECTOR

Central Study Contacts

Kate Lindborg

CONTACT

952-818-8400kate.lindborg@imricor.com

Jennifer Somerville

CONTACT

952-594-4138jennifer.somerville@imricor.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

June 15, 2023

Study Start

June 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

NL(1)CH(1)FR(1)US(3)