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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac mapping and radiofrequency ablation procedure | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are only presenting with:
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
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center Princeton | Birmingham | Alabama | 35211 | United States | ||
| Cardiology Associates of North East Arkansas |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | All subjects enrolled in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All subjects enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis Population, number of subjects ablated per study protocol | Posted | Count of Participants | Participants | during procedure |
|
|
No adverse event data were collected during the procedure. No adverse event data were collected during the 12 month follow-up.
Adverse Events were not collected during this clinical study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | All subjects enrolled in the study. | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Research, Electrophysiology | Abbott | 651-756-3813 | anne.sarver@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2017 | Aug 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D013617 | Tachycardia, Supraventricular |
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Arkansas Cardiology | Little Rock | Arkansas | 72205 | United States |
| Bethesda Memorial Hospital | Boynton Beach | Florida | 33435 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Bryan LGH Medical Center East | Lincoln | Nebraska | 68506 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| Procedure Not Performed |
|
| Enrollment Criteria Not Met |
|
| Procedure Not Performed Per Protocol |
|
| Subject Noncompliance |
|
| No inducible Arrhythmia |
|
| Procedure Not Performed by Trained Physician on Study |
|
| Screen Failure |
|
| Treated Off Label |
|
| No Radiofrequency Ablation |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | 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. | Subjects who completed the 12-month visit post-procedure | Posted | Count of Participants | Participants | 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 |
|
|
|
| 1,065 |
| 0 |
| 0 |
| 0 |
| 0 |
The data and results from the clinical investigation are the sole property of the Sponsor. The Investigators will not use this clinical investigation-related data without the written consent of the Sponsor for any purpose other than for clinical investigation completion or for generation of publication materials, as referenced in the Clinical Trial Agreement. Single-center results are not allowed to be published or presented before the multi-center results.
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D005117 | Cardiac Complexes, Premature |