Atrial Flutter TypicalVISABL-AFLNCT05904548
Atrial Flutter Ablation in the iCMR
A study testing RF Ablation in people with Atrial Flutter Typical, run by Imricor Medical Systems at 6 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Flutter Typical
- What is being tested?
- RF Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 20 Jun 2024to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins University (JHU)
Baltimore, Maryland, 21218
Aravindan Kolandaivelu, MD
- Recruiting
University of Virginia (UVA)
Charlottesville, Virginia, 22903
Kenneth Bilchick, MD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23284
Ajay Pillai, M.D., 478-957-2109, ajay.pillai@vcuhealth.org
Ajay Pillai, M.D.
France1 site, 1 recruiting
- Recruiting
l'institut Cardiologique Paris Sud (ICPS)
Massy, 91300
Laurent Fiorina, MD
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center (AUMC)
Amsterdam
Michiel J.B. Kemme, MD
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Vaud (CHUV)
Lausanne, 1011
Juerg Schwitter, MD
About this study
Official title: Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
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
- Being tested
- RF Ablation
- Keywords
- RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF AblationDevice
RF ablation for type I atrial flutter under iCMR guidance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 7-days post procedure
Secondary outcomes (2)
Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days
The percent of subjects free of documented type I atrial flutter recurrence
Measured: 3 months (90 days)
Chronic Safety Endpoint: all serious adverse event rate for duration of study
Rate of Serious Adverse Events during the clinical investigation as adjudicated by an independent clinical events committee
Measured: 3 months (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start20 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Flutter TypicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imricor Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kate Lindborg, Study director, Imricor Medical Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904548
- Sponsor's protocol ID
- VISABL-AFL
- Acronym
- VISABL-AFL
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes