Prospective Registry on User Experience With The Mapping System For Ablation Procedures (TRUE-HD)

Boston Scientific

Status: Completed

Conditions: Cardiac Arrhythmias

Treatments: Device: IntellaMap Orion mapping catheter; Device: Rhythmia mapping system

Study type: Observational

Funder types: Industry

Identifiers

NCT02698670

91118280

Details and patient eligibility

About

This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

Full description

The TRUE HD Study is aimed at collecting real-world data on the use of the Rhythmia mapping system and the IntellaMap Orion mapping catheter in patients indicated for ablation procedure with use of a 3D Mapping system.

The study will collect specific information on management of ablation procedures with the commercial system including but not limited to acute procedural success, type and proportion of arrhythmias mapped/treated, and how mapping system is used overall. Usage data may be used for the planning of future clinical trials.

Enrollment: 577 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who are eligible for an ablation procedure with the Rhythmia 3D mapping system and IntellaMap Orion mapping catheter according to current international and local guidelines (and future revisions) and per physician discretion;
• Subjects who are willing and capable of providing informed consent;
• Subjects who are willing and capable of participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Subjects whose age is 20 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion criteria

• Subjects requiring de novo ablation of atrial fibrillation;
• Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the sponsor to determine eligibility*;
• The subject is unable or not willing to complete follow-up visits and examination for the duration of the study;
• Subjects who have undergone a previous cardiac ablation within 30 days prior to enrollment;
• Unrecovered/unresolved Adverse Events from any previous invasive procedure;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).