Trial Outcomes & Findings for High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy (NCT NCT03882021)
NCT ID: NCT03882021
Last Updated: 2024-09-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
the end of the 3-month blanking period to 12 months following a single ablation procedure
Results posted on
2024-09-19
Participant Flow
A patient was considered enrolled in the clinical investigation from the moment all of the following enrollment criteria were met: the patient provided written informed consent, patient was confirmed to meet all inclusion criteria and none of the exclusion criteria and the mapping catheter was inserted into the subject's vasculature. If the procedure was cancelled or aborted after consent but prior to the mapping catheter insertion, the subject was withdrawn prior to enrollment.
Participant milestones
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Consent
STARTED
|
303
|
|
Consent
COMPLETED
|
303
|
|
Consent
NOT COMPLETED
|
0
|
|
Enrollment
STARTED
|
303
|
|
Enrollment
COMPLETED
|
300
|
|
Enrollment
NOT COMPLETED
|
3
|
|
Enrollment to 3-Month
STARTED
|
300
|
|
Enrollment to 3-Month
COMPLETED
|
291
|
|
Enrollment to 3-Month
NOT COMPLETED
|
9
|
|
3-Month to 6-Month Visit
STARTED
|
295
|
|
3-Month to 6-Month Visit
COMPLETED
|
294
|
|
3-Month to 6-Month Visit
NOT COMPLETED
|
1
|
|
6-Month to 12-Month Visit
STARTED
|
295
|
|
6-Month to 12-Month Visit
COMPLETED
|
287
|
|
6-Month to 12-Month Visit
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Enrollment
Procedure aborted/cancelled
|
2
|
|
Enrollment
HD Grid catheter not introduced into patient
|
1
|
|
Enrollment to 3-Month
Death
|
1
|
|
Enrollment to 3-Month
Operator not able to achieve PVI
|
4
|
|
Enrollment to 3-Month
Missed Visit
|
4
|
|
3-Month to 6-Month Visit
Missed Visit
|
1
|
|
6-Month to 12-Month Visit
Death
|
1
|
|
6-Month to 12-Month Visit
Missed Visit
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™(GRID) catheter.
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.
|
|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 9.5 • n=300 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=300 Participants
|
|
Sex: Female, Male
Male
|
211 Participants
n=300 Participants
|
|
Region of Enrollment
Austria
|
9 participants
n=300 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=300 Participants
|
|
Region of Enrollment
Czechia
|
68 participants
n=300 Participants
|
|
Region of Enrollment
Italy
|
43 participants
n=300 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=300 Participants
|
|
Region of Enrollment
France
|
74 participants
n=300 Participants
|
|
Region of Enrollment
Portugal
|
5 participants
n=300 Participants
|
|
Region of Enrollment
Germany
|
59 participants
n=300 Participants
|
|
Region of Enrollment
Spain
|
12 participants
n=300 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=300 Participants
|
|
Region of Enrollment
Poland
|
5 participants
n=300 Participants
|
|
Height
|
68.5 inches
STANDARD_DEVIATION 3.8 • n=300 Participants
|
|
Weight
|
189.3 lbs
STANDARD_DEVIATION 37.7 • n=300 Participants
|
|
Body Mass Index (BMI)
|
28.3 kg/m^2
STANDARD_DEVIATION 4.6 • n=300 Participants
|
|
New York Heart Association (NYHA)
I
|
13 Participants
n=82 Participants • Only evaluated for subjects with a history of heart failure.
|
|
New York Heart Association (NYHA)
II
|
48 Participants
n=82 Participants • Only evaluated for subjects with a history of heart failure.
|
|
New York Heart Association (NYHA)
III
|
16 Participants
n=82 Participants • Only evaluated for subjects with a history of heart failure.
|
|
New York Heart Association (NYHA)
IV
|
0 Participants
n=82 Participants • Only evaluated for subjects with a history of heart failure.
|
|
New York Heart Association (NYHA)
Not evaluated
|
5 Participants
n=82 Participants • Only evaluated for subjects with a history of heart failure.
|
|
History of heart failure
|
82 Participants
n=300 Participants
|
|
Transthoracic Echocardiogram (TTE) performed
|
296 Participants
n=300 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
57.4 %
STANDARD_DEVIATION 8.5 • n=288 Participants • Only evaluated in subjects with available data.
|
|
Evidence of left ventricular hypertrophy
|
47 Participants
n=296 Participants • Only evaluated in subjects in which a TTE was performed.
|
|
Evidence of hypertrophic cardiomyopathy
|
6 Participants
n=296 Participants • Only evaluated in subjects in which a TTE was performed.
|
|
History of Hypertension
|
179 Participants
n=300 Participants
|
|
Diabetes
|
34 Participants
n=300 Participants
|
|
Coronary Artery Disease
|
33 Participants
n=300 Participants
|
|
Subject has a pacemaker
|
5 Participants
n=300 Participants
|
|
Valvular Heart Disease
|
69 Participants
n=300 Participants
|
|
Stroke/Transient Ischemic Attack (TIA)/Thromboembolism
|
23 Participants
n=300 Participants
|
|
Paroxysmal Atrial Fibrillation (less than 7 days)
|
113 Participants
n=300 Participants
|
|
Early Persistent Atrial Fibrillation (7 days - 3 months)
|
86 Participants
n=300 Participants
|
|
Non-Early Persistent Atrial Fibrillation (3-12 months)
|
101 Participants
n=300 Participants
|
|
Typical Atrial Flutter
|
47 Participants
n=300 Participants
|
|
Class I/III Anti-arrhythmic drug (AAD) (currently taking/previously taken)
|
186 Participants
n=300 Participants
|
PRIMARY outcome
Timeframe: the end of the 3-month blanking period to 12 months following a single ablation procedureDefined 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.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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
|
57.2 percentage of participants
Interval 51.2 to 62.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: the end of the 3-month blanking period to 12 months after initial ablation procedurePercentage 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.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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 Freedom From Symptomatic AF/AFL/AT After Removal From Antiarrhythmic Drug Therapy
|
61.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: the end of the 3-month blanking period to 12 months following the initial ablation procedureSingle 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.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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 Single Procedure Clinical Success
|
79.4 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: the end of the 3-month blanking period to 12 months following the initial ablation procedureFreedom from atrial fibrillation, atrial flutter and atrial tachycardia recurrence. Kaplan-Meier survival analysis was conducted to analyze time-to-event variables.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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 Freedom From AF/AFL/AT
|
75.5 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During procedure, an average of 160 minutesDefined as electrical isolation of all pulmonary veins. The data will be summarized with subject counts and percentages/rates.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Number of Subjects With Acute Procedural Success
|
296 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Subjects with repeat electrophysiology studies in which treatment other than ablation of isthmus dependent atrial flutter was performed.
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.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=25 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Number of Subjects With Arrhythmia Recurrence
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Number of subjects in which LAV was measured.
LA volume will be summarized with the mean with standard deviation.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=151 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Left Atrium (LA) Information: LA Volume (LAV)
|
68.5 mL
Standard Deviation 31.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Includes subjects in which LAD was measured
LA diameter will be summarized with the mean with standard deviation.
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=226 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Left Atrium (LA) Information: LA Diameter (LAD)
|
43.1 mm
Standard Deviation 12.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsNumber of adverse events, including any device-, procedure-, or death-related events (serious or non-serious).
Outcome measures
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 Participants
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Reportable Adverse Events
|
15 events
|
Adverse Events
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
Serious events: 8 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 participants at risk
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Cardiac disorders
Arrhythmia New
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Vascular disorders
Arteriovenous fistula
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Infections and infestations
Endocarditis
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Cardiac disorders
Valve insufficiency
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
General disorders
Neurological symptoms
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.33%
1/300 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Mapping Protocol With Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ Catheter
n=300 participants at risk
All patients will undergo a protocol required mapping protocol using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (GRID) catheter.
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.
|
|---|---|
|
Vascular disorders
Arteriovenous fistula
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Bleeding/Anemia
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericardial Effusion
|
0.67%
2/300 • Number of events 2 • 1 year
|
|
Vascular disorders
Pulmonary Vein Stenosis
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.33%
1/300 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea at exercise
|
0.33%
1/300 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee First publication of study results will be made as a joint multi-center publication with investigators from all sites contributing data. Institutions may publish data and results individually from its site after any of the following (1) a multi-center publication is published, (2) no multicenter publication is submitted within eighteen months after closures of the Study at all sites or (3) sponsor confirms in writing there will be no multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER