Prospective Registry on User Experience With The Mapping System For Ablation Procedures
- Conditions
- Cardiac Arrhythmias
- Registration Number
- NCT02698670
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 577
- 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.
- 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).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute Procedural Success At the end of the index procedure (Day 0) Primary endpoint is the acute procedural success for the primary arrhythmia in the whole cohort of ablation procedures. A procedure will be defined successful if all the following conditions will occur during the case: 1) ability to map, 2) completion of the necessary ablation applications, 3) primary arrhythmia termination (when applicable), and 4) validation of ablation through appropriate technique(s).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
Baptist Memorial Hosptial
🇺🇸Memphis, Tennessee, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Riverside Methodist - Ohio Health
🇺🇸Cincinnati, Ohio, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Torrance Memorial Medical Center
🇺🇸Torrance, California, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
University of Michigan Hospitals
🇺🇸Ann Arbor, Michigan, United States
Strong Memorial Hospital of the University of Rochester
🇺🇸Rochester, New York, United States
University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
Maimonidies Hospital
🇺🇸New York, New York, United States
University of North Carolina Hospital
🇺🇸Chapel Hill, North Carolina, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
Heart Rhythm Institute
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Trinity Mother Francis
🇺🇸Tyler, Texas, United States
Wesley Medical Research
🇦🇺Brisbane, Queensland, Australia
CHU de Bordeaux
🇫🇷Pessac, France
Hoag Memorial Hospital
🇺🇸Orange, California, United States
Centre Hôpital Universitaire Rangueil
🇫🇷Toulouse, France
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Universitaetsklinik Eppendorf
🇩🇪Hamburg, Germany
The Brompton Hospital
🇬🇧London, United Kingdom
Herzzentrum Universität Leipzig
🇩🇪Leipzig, Germany
Harefield Hospital
🇬🇧London, United Kingdom
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong