An observational study in Cardiac Arrhythmia, sponsored by Abbott Medical Devices. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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.
The EnSite Precision™ Cardiac Mapping System is a newly developed system that introduces features such as Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) image integration, lesion marking automaticity, automatic mapping, and workflow flexibility to aid in the success of complex ablation procedures. Utilization of this system in the treatment of complex ablation procedures and its impact on patient outcomes is not well characterized. This clinical study is designed to collect a broad range of usage scenarios, therefore this clinical study has limited patient selection criteria and data collection is focused on EnSite Precision™ Cardiac Mapping System usage and patient outcomes.
The data collected from the procedure (performed per Instructions For Use (IFU) and per standard practice of the physician) as well as the 12 month follow up period enables the Sponsor to review the system's standard practice usage. This information will be added to the current knowledge and understanding of treatment options for patients with arrhythmias, which can assist the Sponsor to provide future recommendations for best practices to improve patient outcomes.
1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.
This study's enrollment of 1,065 is above the median of 200 across 467 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
The intended population for this clinical study is patients over the age of 18 years who are eligible for a cardiac electrophysiology mapping and radiofrequency ablation procedure using the EnSite Precision™ Cardiac Mapping System.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who are only presenting with:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome. Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart).
Rate of Acute Success Based on Pre-defined Procedural Endpoints
The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.
Time frame: during procedure
Freedom From Arrhythmia Recurrence
This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.
Time frame: 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
| Milestone | All Subjects |
|---|---|
| Started | 1065 |
| Treated | 925 |
| 1-month follow up | 898 |
| 6-month follow up | 765 |
| 12-month follow up | 722 |
| Completed | 779 |
| Not completed | 286 |
| Withdrew: Death | 19 |
| Withdrew: Lost to follow-up | 60 |
| Withdrew: Withdrawal by subject | 48 |
| Withdrew: Procedure not performed | 21 |
| Withdrew: Enrollment criteria not met | 31 |
| Withdrew: Procedure not performed per protocol | 12 |
| Withdrew: Subject noncompliance | 6 |
| Withdrew: No inducible arrhythmia | 2 |
| Withdrew: Procedure not performed by trained physician on study | 2 |
| Withdrew: Screen failure | 2 |
| Withdrew: Treated off label | 69 |
| Withdrew: No radiofrequency ablation | 14 |
The number and proportion of subjects with acute success will be summarized. Acute success was defined as the physician's goal or intention for the procedure.
| Participants | All Subjects |
|---|---|
| Rate of Acute Success Based on Pre-defined Procedural Endpoints | 901 |
This analysis will be performed using the Kaplan-Meier (KM) analyses. The start date is the date of the index procedure. For subjects who do not experience an event, their follow up duration will be defined from the start date to the date of death, withdrawal, or last follow-up, whichever occurred later.
| Participants | All Subjects |
|---|---|
| Freedom From Arrhythmia Recurrence | 471 |
Collected over No adverse event data were collected during the procedure. No adverse event data were collected during the 12 month follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | 20/1,065 (1.9%) | — | — |
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 64.3 ± 11.6 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 279 |
| Male | 646 |
| Race and Ethnicity Not Collected(Participants) | All Subjects |
|---|
| Region of Enrollment(Participants) | All Subjects |
|---|---|
| United States | 751 |
| Canada | 174 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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