Recruiting

Atrial Flutter Ablation

Sponsor:

Imricor Medical Systems

Code:

NCT05904548

Conditions

Atrial Flutter Typical

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RF Ablation

Study Details

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.

Conditions

Atrial Flutter Typical

Study ID

NCT05904548

Start date

Jun 20, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Active systemic infection
  • Pregnancy or if subject plans to become pregnant during the trial
  • Uncontrolled hyperthyroidism
  • Any other significant uncontrolled or unstable medical condition
  • Enrollment in any concurrent study without Imricor written approval
  • Life expectancy of less than or equal to 2 years (730 days) per physician opinion

Study Design

Enrollment

91 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vision-MR Atrial Flutter Ablation

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.

Interventions

RF Ablation

RF ablation for type I atrial flutter under iCMR guidance

Primary outcome measure

  • Primary Efficacy Endpoint: Bi-directional block confirmation [ Time Frame: Time of procedure, following delivery of last ablation energy delivery point ]
  • Primary Safety Endpoint: Composite of serious cardiovascular adverse events [ Time Frame: 7-days post procedure ]

Central Contacts and Locations

Central contacts

Kate Lindborg

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

Jennifer Somerville

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

Locations

Johns Hopkins University (JHU)

Recruiting

Baltimore, Maryland, United States, 21218

Principal Investigator:

Aravindan Kolandaivelu, MD

More Information

Sponsor

Imricor Medical Systems

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • RF Ablation
  • interventional Cardiac Magnetic Resonance (iCMR)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Imricor Medical Systems on 2026-04-13.