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
- Are there results?
- Not yet: the study is under way
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
Show all 21Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
- ClinicalTrials.gov ID
- NCT05904548
- Acronym / sponsor ID
- VISABL-AFL / VISABL-AFL
- Conditions
- Atrial Flutter Typical
- Keywords
- RF Ablation, interventional Cardiac Magnetic Resonance (iCMR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Imricor Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vision-MR Atrial Flutter Ablation | Experimental | Device: RF AblationType 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF AblationRF ablation for type I atrial flutter under iCMR guidance | Device | Vision-MR Atrial Flutter Ablation |
Primary outcome
Primary Efficacy Endpoint: Bi-directional block confirmation
Time frame: Time of procedure, following delivery of last ablation energy delivery point
Confirmation of bidirectional conduction block of the CTI with the Vision-MR Ablation Catheter 2.0 and Osypka HAT 500 RF generator \& irrigation pump.
Primary Safety Endpoint: Composite of serious cardiovascular adverse events
Time frame: 7-days post procedure
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
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kate Lindborg study director
Imricor Medical Systems, Inc.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF Ablation in people with Atrial Flutter Typical, run by Imricor Medical Systems at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Lindborg (952-818-8400, kate.lindborg@imricor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint: Bi-directional block confirmation (time frame: Time of procedure, following delivery of last ablation energy delivery point). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.