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Recruiting NCT05904548

Atrial Flutter Ablation in the iCMR

No phase Interventional Atrial Flutter Typical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RF Ablation.
Who it may be relevant to
Registry conditions: Atrial Flutter Typical. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Netherlands, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Device RF Ablation
    RF ablation for type I atrial flutter under iCMR guidance

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days [Time frame: 3 months (90 days)]
  • Chronic Safety Endpoint: all serious adverse event rate for duration of study [Time frame: 3 months (90 days)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Johns Hopkins University (JHU) — Baltimore
  • University of Virginia (UVA) — Charlottesville
  • Virginia Commonwealth University — Richmond
France · 1 center
  • l'institut Cardiologique Paris Sud (ICPS) — Massy
Netherlands · 1 center
  • Amsterdam University Medical Center (AUMC) — Amsterdam
Switzerland · 1 center
  • University Hospital of Vaud (CHUV) — Lausanne

Identifiers

NCT: NCT05904548 · VISABL-AFL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗