CompletedNot Applicable

EnSite Precision Observational Study

United States1,065 participantsStarted 2017-09-12

Plain-language summary

This document is a clinical investigation plan (CIP) for the EnSite Precision Observational Study. This clinical study is intended to quantify and characterize the usage of the EnSite Precision™ Cardiac Mapping System (Software version 2.0.1 or higher) in a real-world environment. This study will be conducted in patients who are indicated for a cardiac electrophysiological (EP) mapping and radio frequency ablation procedure using a three-dimensional system.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Indicated for a cardiac electrophysiology mapping and radiofrequency ablation procedure using a 3-dimensional mapping system per Instructions for Use * Over 18 years of age * Able to provide informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule Exclusion Criteria: * Patients who are only presenting with: * Atrioventricular Nodal Reentrant Tachycardia (AVNRT) * Atrioventricular Reentrant Tachycardia (AVRT) * Planned cryoablation procedure * Implanted with a neurostimulator * Contraindication to anticoagulation * Known presence of cardiac thrombus * Recent (\<3 months) myocardial infarction or unstable angina or coronary artery by-pass * Currently enrolled in a clinical study/investigation evaluating another device or drug that would confound the results of this study * Pregnant or nursing * Individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of the autonomy due to immaturity, or mental disability, or adverse personal circumstances, or hierarchical influence

What they're measuring

Rate of Acute Success Based on Pre-defined Procedural Endpoints

Timeframe: during procedure

Freedom From Arrhythmia Recurrence

Timeframe: From date of procedure until the date of first documented arrhythmia recurrence or date of study completion or withdrawal for any cause, whichever came first, assessed up to 12 months

Trial details

NCT IDNCT03260244

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-01-17

Results submitted2024-08-23

View on ClinicalTrials.gov More Cardiac Arrhythmia trials