Atrial Flutter Ablation in the ICMR

Description

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

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Study Overview

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Study Details

Study overview

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.

Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter

Atrial Flutter Ablation in the ICMR

Condition
Atrial Flutter Typical
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Imricor Medical Systems,

Kate Lindborg, PhD, STUDY_DIRECTOR, Imricor Medical Systems, Inc.

Study Record Dates

2024-12-31