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The purpose of this clinical study is to collect safety and performance data to support a demonstration of substantial equivalence of the Catheter Robotics Remote Catheter System to predicate devices when used to perform EP mapping of the right heart (atrium and ventricle).
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Inclusion criteria
Exclusion criteria
Any contraindication to cardiac catheterization, including pregnancy.
Enrollment in any other ongoing cardiac device trial.
Right-sided cardiac prosthetics including implanted active energy devices with permanent leads in or through the right atrium and/or ventricle.
Corrected or uncorrected atrial septal defect (ASD).
Poor general health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e., other disease processes, mental capacity, etc.).
Medical condition that will require anticoagulation during study or ablation procedure.
Presence of atrial fibrillation or atrial flutter at time of study procedure.
Other condition observed prior to the procedure where, in the view of the physician, participation in the study could further present a risk to the subject.
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Interventional model
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181 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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