RECRUITING

Atrial Flutter Ablation in the ICMR

Conditions

Atrial Flutter Typical RF Ablation interventional Cardiac Magnetic Resonance (iCMR)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-20

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05904548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Kate Lindborg, PhD

CONTACT

9528188400

kate.lindborg@imricor.com

Principal Investigator

Kate Lindborg, PhD

STUDY_DIRECTOR

Imricor Medical Systems, Inc.

Study Locations (Sites)

Johns Hopkins University

Baltimore, Maryland, 21218

United States

Collaborators and Investigators

Sponsor: Imricor Medical Systems

Kate Lindborg, PhD, STUDY_DIRECTOR, Imricor Medical Systems, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-20

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2024-06-20

Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

RF Ablation
interventional Cardiac Magnetic Resonance (iCMR)

Additional Relevant MeSH Terms

Atrial Flutter Typical