Cardiac Arrhythmias
Conditions
Keywords
Cardiac Arrhythmias, Cardiovascular Disease, Radiofrequency Ablation, Cardiac Mapping
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.
Interventions
DEVICERhythmia mapping system
A 3-D Cardiac Mapping system
DEVICEIntellaMap Orion mapping catheter
A diagnostic basket mapping catheter
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Australia, France, Germany, Hong Kong, Netherlands, Spain, United Kingdom, United States
Outcome results
None listed