Cardiac Arrhythmia
Conditions
Keywords
atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, premature ventricular contractions, cardiac mapping system
Brief 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.
Detailed description
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.
Interventions
PROCEDUREcardiac mapping and radiofrequency ablation 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).
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Acute Success Based on Pre-defined Procedural Endpoints | during procedure | 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. |
| Freedom From Arrhythmia Recurrence | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects enrolled in the study. | 925 |
| Total | 925 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 19 |
| Overall Study | Enrollment Criteria Not Met | 31 |
| Overall Study | Lost to Follow-up | 60 |
| Overall Study | No inducible Arrhythmia | 2 |
| Overall Study | No Radiofrequency Ablation | 14 |
| Overall Study | Procedure Not Performed | 21 |
| Overall Study | Procedure Not Performed by Trained Physician on Study | 2 |
| Overall Study | Procedure Not Performed Per Protocol | 12 |
| Overall Study | Screen Failure | 2 |
| Overall Study | Subject Noncompliance | 6 |
| Overall Study | Treated Off Label | 69 |
| Overall Study | Withdrawal by Subject | 48 |
Baseline characteristics
| Characteristic | All Subjects | — |
|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 11.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 174 Participants | — |
| Region of Enrollment United States | 751 Participants | — |
| Sex: Female, Male Female | 279 Participants | — |
| Sex: Female, Male Male | 646 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 1,065 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
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
Population: Subjects who completed the 12-month visit post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Freedom From Arrhythmia Recurrence | 471 Participants |
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.
Time frame: during procedure
Population: Analysis Population, number of subjects ablated per study protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Subjects | Rate of Acute Success Based on Pre-defined Procedural Endpoints | 901 Participants |