Prospective Registry on User Experience With The Mapping System For Ablation Procedures
TRUE-HD
1 other identifier
observational
577
8 countries
28
Brief Summary
This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Shorter than P25 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedStudy Start
First participant enrolled
May 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJanuary 25, 2018
June 1, 2017
11 months
February 24, 2016
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Procedural Success
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).
At the end of the index procedure (Day 0)
Interventions
A 3-D Cardiac Mapping system
A diagnostic basket mapping catheter
Eligibility 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
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Hoag Memorial Hospital
Orange, California, 92868, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
University of Chicago Hospital
Chicago, Illinois, 60637, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
University of Michigan Hospitals
Ann Arbor, Michigan, 48109, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
Maimonidies Hospital
New York, New York, 11219, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599, United States
Riverside Methodist - Ohio Health
Cincinnati, Ohio, 43214, United States
Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Heart Rhythm Institute
Oklahoma City, Oklahoma, 73104, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Baptist Memorial Hosptial
Memphis, Tennessee, 38138, United States
Trinity Mother Francis
Tyler, Texas, 75701, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Wesley Medical Research
Brisbane, Queensland, 4001, Australia
CHU de Bordeaux
Pessac, 33604, France
Centre Hôpital Universitaire Rangueil
Toulouse, 31059, France
Universitaetsklinik Eppendorf
Hamburg, 20251, Germany
Herzzentrum Universität Leipzig
Leipzig, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
University Medical Center Groningen
Groningen, Netherlands
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Harefield Hospital
London, SW3 6NP, United Kingdom
The Brompton Hospital
London, SW3 6NP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerhard Hindricks
Gerhard Hindricks
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2016
First Posted
March 4, 2016
Study Start
May 25, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
January 25, 2018
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share