Prospective Registry on User Experience With The Mapping System For Ablation Procedures
NCT ID: NCT02698670
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
577 participants
OBSERVATIONAL
2016-05-25
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Rhythmia mapping system
A 3-D Cardiac Mapping system
IntellaMap Orion mapping catheter
A diagnostic basket mapping catheter
Eligibility Criteria
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Inclusion Criteria
* 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 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).
20 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gerhard Hindricks
Role: PRINCIPAL_INVESTIGATOR
Gerhard Hindricks
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Hoag Memorial Hospital
Orange, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
University of Chicago Hospital
Chicago, Illinois, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Maimonidies Hospital
New York, New York, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Riverside Methodist - Ohio Health
Cincinnati, Ohio, 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
Baptist Memorial Hosptial
Memphis, Tennessee, United States
Trinity Mother Francis
Tyler, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Wesley Medical Research
Brisbane, Queensland, Australia
CHU de Bordeaux
Pessac, , France
Centre Hôpital Universitaire Rangueil
Toulouse, , France
Universitaetsklinik Eppendorf
Hamburg, , Germany
Herzzentrum Universität Leipzig
Leipzig, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
University Medical Center Groningen
Groningen, , Netherlands
Clinica Universitaria de Navarra
Pamplona, , Spain
Harefield Hospital
London, , United Kingdom
The Brompton Hospital
London, , United Kingdom
Countries
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Other Identifiers
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91118280
Identifier Type: -
Identifier Source: org_study_id
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