Prospective Registry on User Experience With The Mapping System For Ablation Procedures

Completed

Conditions studied: Cardiac Arrhythmias

In brief

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

Key facts

Study ID

NCT02698670

Run by

Boston Scientific Corporation

People needed

577

Starts

2016-05-25

Expected to finish

2017-05-01

Last updated by the study team

2018-01-25

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.