EnSite Precision Observational Study (NCT03260244) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of Acute Success Based on Pre-defined Procedural Endpoints
Timeframe: during procedure
2
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