Clinical trial NCT05904548: Atrial Flutter Ablation in the iCMR
Official title: Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Flutter Typical
Keywords: RF Ablation
interventional Cardiac Magnetic Resonance (iCMR)
Lead sponsor: Imricor Medical Systems
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 Catheter 2.0 in the iCMR environment.


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

Primary outcomes:
measure: Primary Efficacy Endpoint: Bi-directional block confirmation
timeFrame: Time of procedure, following delivery of last ablation energy delivery point
measure: Primary Safety Endpoint: Composite of serious cardiovascular adverse events
timeFrame: 7-days post procedure
Secondary outcomes:
measure: Chronic Efficacy Endpoint: Freedom from type 1 atrial flutter at 90 days
timeFrame: 3 months (90 days)
measure: Chronic Safety Endpoint: all serious adverse event rate for duration of study
timeFrame: 3 months (90 days)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Massy
country: France
facility: l'institut Cardiologique Paris Sud (ICPS)
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center (UMC)
city: Lausanne
country: Switzerland
facility: University Hospital of Vaud (CHUV)
Study officials:
affiliation: Imricor Medical Systems, Inc.
name: Kate Lindborg, PhD
role: STUDY_DIRECTOR
References: