N/A
Completed N=1,065
EnSite Precision Observational Study
Cardiac Arrhythmia
Source: ClinicalTrials.gov NCT03260244 ↗
Enrolled (actual)
1,065
Serious AEs
—
Results posted
Nov 2024
Primary outcomePrimary: Rate of Acute Success Based on Pre-defined Procedural Endpoints — 901 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Acute Success Based on Pre-defined Procedural Endpoints |
901 | — |
| PRIMARY Freedom From Arrhythmia Recurrence |
471 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03260244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.