Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
91 participants
INTERVENTIONAL
2024-06-20
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
RF Ablation
RF ablation for type I atrial flutter under iCMR guidance
Interventions
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RF Ablation
RF ablation for type I atrial flutter under iCMR guidance
Eligibility Criteria
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Inclusion Criteria
* Patient 18 years and older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Imricor Medical Systems
INDUSTRY
Responsible Party
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Principal Investigators
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Kate Lindborg, PhD
Role: STUDY_DIRECTOR
Imricor Medical Systems, Inc.
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
l'institut Cardiologique Paris Sud (ICPS)
Massy, , France
Amsterdam University Medical Center (UMC)
Amsterdam, , Netherlands
University Hospital of Vaud (CHUV)
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Aravindan Kolandaivelu, MD
Role: primary
Laurent Fiorina, MD
Role: primary
Cornelis Allaart
Role: primary
Juerg Schwitter, MD
Role: primary
Other Identifiers
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VISABL-AFL
Identifier Type: -
Identifier Source: org_study_id
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