An interventional study of A specific electrophysiology mapping protocol is applicable with the GRID catheter. in Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation and Cardiac Arrhythmia, sponsored by Abbott Medical Devices. Completed at 15 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Diagnostic
The aim is to use the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.
This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.
Approximately 300 subjects at up to 20 sites worldwide will be enrolled.
Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 300 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
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Exclusion Criteria:
All patient will undergo a protocol required mapping protocol using the GRID catheter.
Procedure: A specific electrophysiology mapping protocol is applicable with the GRID catheter.
The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
Percentage of Subjects With One-year Success
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following a single ablation procedure
Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy
Percentage of participants with freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia rafter removal from AADs. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months after initial ablation procedure
Percentage of Subjects With Single Procedure Clinical Success
Single procedure clinical success was defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
Percentage of Subjects With Freedom From AF/AFL/AT
Freedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Time frame: the end of the 3-month blanking period to 12 months following the initial ablation procedure
Number of Subjects With Acute Procedural Success
Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates.
Time frame: During procedure, an average of 160 minutes
Number of Subjects With Arrhythmia Recurrence
Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates.
Time frame: 12 months
Left Atrium (LA) Information: LA Volume (LAV)
LA volume will be summarized with the mean with standard deviation.
Time frame: Baseline
Left Atrium (LA) Information: LA Diameter (LAD)
LA diameter will be summarized with the mean with standard deviation.
Time frame: Baseline
Reportable Adverse Events
Number of adverse events, including any device-, procedure-, or death-related events (serious or non-serious).
Time frame: 12 months
| Milestone | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Started | 303 |
| Completed | 303 |
| Not completed | 0 |
| Milestone | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Started | 303 |
| Completed | 300 |
| Not completed | 3 |
| Withdrew: Procedure aborted/cancelled | 2 |
| Withdrew: Hd grid catheter not introduced into patient | 1 |
| Milestone | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Started | 300 |
| Completed | 291 |
| Not completed | 9 |
| Withdrew: Death | 1 |
| Withdrew: Operator not able to achieve pvi | 4 |
| Withdrew: Missed visit | 4 |
| Milestone | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Started | 295 |
| Completed | 294 |
| Not completed | 1 |
| Withdrew: Missed visit | 1 |
| Milestone | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Started | 295 |
| Completed | 287 |
| Not completed | 8 |
| Withdrew: Death | 1 |
| Withdrew: Missed visit | 7 |
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.
| percentage of participants | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Percentage of Subjects With One-year Success | 57.2 (51.2 to 62.8) |
Percentage of participants with freedom from symptomatic atrial fibrillation/atrial flutter/atrial tachycardia rafter removal from AADs. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
| percentage of participants | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Percentage of Subjects With Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy | 61.7 |
Single procedure clinical success was defined as freedom from symptomatic atrial fibrillation, atrial flutter and atrial tachycardia without a new or increased dose of class I or III antiarrhythmic drug. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
| percentage of participants | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Percentage of Subjects With Single Procedure Clinical Success | 79.4 |
Freedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
| percentage of participants | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Percentage of Subjects With Freedom From AF/AFL/AT | 75.5 |
Defined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates.
| Participants | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Number of Subjects With Acute Procedural Success | 296 |
Rates of recurrence not due to PVI gap for subjects with repeat electrophysiology studies. The data will be summarized with subject counts and percentages/rates.
| Participants | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Number of Subjects With Arrhythmia Recurrence | 3 |
LA volume will be summarized with the mean with standard deviation.
| mL | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Left Atrium (LA) Information: LA Volume (LAV) | 68.5 ± 31.9 |
LA diameter will be summarized with the mean with standard deviation.
| mm | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Left Atrium (LA) Information: LA Diameter (LAD) | 43.1 ± 12.2 |
Number of adverse events, including any device-, procedure-, or death-related events (serious or non-serious).
| events | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Reportable Adverse Events | 15 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter | 2/300 (0.7%) | 8/300 (2.7%) | 7/300 (2.3%) |
| Event | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Arrhythmia NewCardiac disorders | 1/300 |
| PneumoniaInfections and infestations | 1/300 |
| Arteriovenous fistulaVascular disorders | 1/300 |
| EndocarditisInfections and infestations | 1/300 |
| HypotensionVascular disorders | 1/300 |
| Valve insufficiencyCardiac disorders | 1/300 |
| Neurological symptomsGeneral disorders | 1/300 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 1/300 |
| Event | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Pericardial EffusionCardiac disorders | 2/300 |
| Arteriovenous fistulaVascular disorders | 1/300 |
| Bleeding/AnemiaBlood and lymphatic system disorders | 1/300 |
| Pulmonary Vein StenosisVascular disorders | 1/300 |
| HematuriaRenal and urinary disorders | 1/300 |
| Dyspnea at exerciseRespiratory, thoracic and mediastinal disorders | 1/300 |
| Age, Continuous(years) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Mean | 62.0 ± 9.5 |
| Sex: Female, Male(Participants) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Female | 89 |
| Male | 211 |
| Race and Ethnicity Not Collected(Participants) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|
| Region of Enrollment(participants) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Austria | 9 |
| Netherlands | 13 |
| Czechia | 68 |
| Italy | 43 |
| United Kingdom | 10 |
| France | 74 |
| Portugal | 5 |
| Germany | 59 |
| Spain | 12 |
| Israel | 2 |
| Poland | 5 |
| Height(inches) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Mean | 68.5 ± 3.8 |
| Weight(lbs) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Mean | 189.3 ± 37.7 |
| Body Mass Index (BMI)(kg/m^2) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| Mean | 28.3 ± 4.6 |
| New York Heart Association (NYHA)(Participants) | Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter |
|---|---|
| I | 13 |
| II | 48 |
| III | 16 |
| IV | 0 |
| Not evaluated | 5 |
16 further baseline measures are reported on the registry.
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