Trial Outcomes & Findings for HD Mapping of Atrial Fibrillation in Asia Pacific (NCT NCT04022954)
NCT ID: NCT04022954
Last Updated: 2024-03-29
Results Overview
The rate of acute success was defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion \* 100%) with acute success is also displayed as the result of an automatic calculation.
COMPLETED
200 participants
End of Procedure
2024-03-29
Participant Flow
Of 201 consented patients, 200 met the protocol definition for subject enrollment (including written informed consent AND HD mapping catheter inserted) and were considered enrolled in the study. One consented subject was a screen failure due to operator choice of a different system (non-study device) prior to procedure. Because a study-specified HD mapping catheter was not inserted, this patient was withdrawn prior to the Baseline Visit as a consented non-enrolled screen failure.
Participant milestones
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Consented to Completed Procedure
STARTED
|
201
|
|
Consented to Completed Procedure
COMPLETED
|
200
|
|
Consented to Completed Procedure
NOT COMPLETED
|
1
|
|
Completed 12-month Follow-up
STARTED
|
200
|
|
Completed 12-month Follow-up
COMPLETED
|
192
|
|
Completed 12-month Follow-up
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Consented to Completed Procedure
Consented Screen Failure
|
1
|
|
Completed 12-month Follow-up
Lost to Follow-up
|
5
|
|
Completed 12-month Follow-up
Withdrawal by Subject
|
3
|
Baseline Characteristics
No baseline height from one subject.
Baseline characteristics by cohort
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Age, Continuous
|
63.0 years
STANDARD_DEVIATION 11.0 • n=200 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=200 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Asian
|
200 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=200 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=200 Participants
|
|
Region of Enrollment
South Korea
|
37 participants
n=200 Participants
|
|
Region of Enrollment
Hong Kong
|
11 participants
n=200 Participants
|
|
Region of Enrollment
China
|
6 participants
n=200 Participants
|
|
Region of Enrollment
Japan
|
101 participants
n=200 Participants
|
|
Region of Enrollment
Taiwan
|
45 participants
n=200 Participants
|
|
Height
|
166.0 centimeters
STANDARD_DEVIATION 9.8 • n=199 Participants • No baseline height from one subject.
|
|
Weight
|
69.0 kilograms
STANDARD_DEVIATION 14.6 • n=199 Participants • No baseline weight from one subject.
|
|
Heart Rate on ECG
|
72.9 bpm
STANDARD_DEVIATION 20.3 • n=195 Participants • No Heart rate on ECG data at baseline for 5 subjects.
|
|
Rhythm on ECG
Sinus Rhythm
|
127 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Atrial Fibrillation
|
37 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Typical Atrial Flutter (CTI dependent)
|
4 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Atypical Atrial Flutter (non-CTI dependent)
|
7 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Sinus rhythm with PVC
|
2 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
A-paced with intrinsic conduction
|
1 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Sinus rhythm with PAC
|
1 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Sinus bradycardia
|
14 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
Rhythm on ECG
Other
|
3 Participants
n=196 Participants • Rhythm on ECG is only available for 196/200 enrolled subjects.
|
|
History of Heart Failure
History of Heart Failure
|
15 Participants
n=200 Participants • Analysis population for New York Heart Association (NYHA) heart failure classes only includes those subjects with a history of heart failure. NYHA class is a standardized, widely accepted measure of heart failure symptom severity (see for example CW Yancy et al., Circulation, 128 (2013), pp. e240-e327). A patient can be evaluated by a cardiologist (heart doctor) to determine if heart failure symptoms are present and to classify the severity from Class I (least severe) to Class IV (most severe).
|
|
History of Heart Failure
Class I
|
6 Participants
n=15 Participants • Analysis population for New York Heart Association (NYHA) heart failure classes only includes those subjects with a history of heart failure. NYHA class is a standardized, widely accepted measure of heart failure symptom severity (see for example CW Yancy et al., Circulation, 128 (2013), pp. e240-e327). A patient can be evaluated by a cardiologist (heart doctor) to determine if heart failure symptoms are present and to classify the severity from Class I (least severe) to Class IV (most severe).
|
|
History of Heart Failure
Class II
|
3 Participants
n=15 Participants • Analysis population for New York Heart Association (NYHA) heart failure classes only includes those subjects with a history of heart failure. NYHA class is a standardized, widely accepted measure of heart failure symptom severity (see for example CW Yancy et al., Circulation, 128 (2013), pp. e240-e327). A patient can be evaluated by a cardiologist (heart doctor) to determine if heart failure symptoms are present and to classify the severity from Class I (least severe) to Class IV (most severe).
|
|
History of Heart Failure
Class III
|
1 Participants
n=15 Participants • Analysis population for New York Heart Association (NYHA) heart failure classes only includes those subjects with a history of heart failure. NYHA class is a standardized, widely accepted measure of heart failure symptom severity (see for example CW Yancy et al., Circulation, 128 (2013), pp. e240-e327). A patient can be evaluated by a cardiologist (heart doctor) to determine if heart failure symptoms are present and to classify the severity from Class I (least severe) to Class IV (most severe).
|
|
History of Heart Failure
Class IV
|
0 Participants
n=15 Participants • Analysis population for New York Heart Association (NYHA) heart failure classes only includes those subjects with a history of heart failure. NYHA class is a standardized, widely accepted measure of heart failure symptom severity (see for example CW Yancy et al., Circulation, 128 (2013), pp. e240-e327). A patient can be evaluated by a cardiologist (heart doctor) to determine if heart failure symptoms are present and to classify the severity from Class I (least severe) to Class IV (most severe).
|
|
History of Heart Failure
Not Evaluated
|
5 Participants
n=15 Participants • Analysis population for New York Heart Association (NYHA) heart failure classes only includes those subjects with a history of heart failure. NYHA class is a standardized, widely accepted measure of heart failure symptom severity (see for example CW Yancy et al., Circulation, 128 (2013), pp. e240-e327). A patient can be evaluated by a cardiologist (heart doctor) to determine if heart failure symptoms are present and to classify the severity from Class I (least severe) to Class IV (most severe).
|
|
Cardiomyopathy
|
6 Participants
n=200 Participants
|
|
Valvular Heart Disease
|
17 Participants
n=200 Participants
|
|
Hypertension
|
105 Participants
n=200 Participants
|
|
Stroke/TIA/Thromboembolism
|
15 Participants
n=196 Participants • No history of stroke/TIA/thromboembolism collected at baseline for 4 subjects.
|
|
Conduction Disease
|
8 Participants
n=200 Participants
|
|
Arrhythmia History
Paroxysmal
|
169 Participants
n=200 Participants
|
|
Arrhythmia History
Persistent
|
23 Participants
n=200 Participants
|
|
Arrhythmia History
Longstanding Persistent
|
6 Participants
n=200 Participants
|
|
Arrhythmia History
Typical Flutter
|
21 Participants
n=200 Participants
|
|
Arrhythmia History
Atypical Flutter
|
3 Participants
n=200 Participants
|
|
Arrhythmia History
Type Unknown Flutter
|
5 Participants
n=200 Participants
|
|
Arrhythmia History
Atrial Tachycardia
|
2 Participants
n=200 Participants
|
|
Arrhythmia History
Multifocal AT
|
0 Participants
n=200 Participants
|
|
Arrhythmia History
AVRT/Accessory Pathway
|
0 Participants
n=200 Participants
|
|
Arrhythmia History
AVNRT
|
1 Participants
n=200 Participants
|
|
Arrhythmia History
Ischemic Ventricular Tachycardia
|
0 Participants
n=200 Participants
|
|
Arrhythmia History
Non-ischemic ventricular tachycardia
|
0 Participants
n=200 Participants
|
|
Arrhythmia History
Idiopathic Ventricular Tachycardia
|
1 Participants
n=200 Participants
|
|
Arrhythmia History
PVCs
|
8 Participants
n=200 Participants
|
|
Indication for this procedure
Symptomatic Paroxysmal AF
|
165 Participants
n=200 Participants
|
|
Indication for this procedure
Symptomatic Persistent AF
|
35 Participants
n=200 Participants
|
|
History of Class I or III AAD use
|
155 Participants
n=200 Participants
|
PRIMARY outcome
Timeframe: End of ProcedureThe rate of acute success was defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion \* 100%) with acute success is also displayed as the result of an automatic calculation.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.
|
173 Participants
|
PRIMARY outcome
Timeframe: 12 months post-procedurePopulation: Overall Number of Participants Analyzed is the number of subjects that have completed a 24-hour Holter at 12 months.
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=182 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Participants With Clinical Long-Term Success
|
168 Participants
|
PRIMARY outcome
Timeframe: 12-month post-procedurePopulation: Overall Number of Participants Analyzed is the number of subjects that have completed a 24-hour Holter at 12 months or have documented Class I or III AAD use between the end of the blanking period and 12-months.
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=189 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Participants With AAD-Free Long-Term Success
|
104 Participants
|
SECONDARY outcome
Timeframe: During ProcedureDefined as time from initial catheter insertion to final catheter removal. This is one measure of the amount of time it took for the physician to use invasive tools (catheters) during the procedure to investigate, diagnose, and treat the participant's heart condition.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Overall Procedure Time
|
152.9 minutes
Standard Deviation 50.3
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: Overall Number of Participants Analyzed is the number of subjects with available data for this outcome.
Defined as duration of time radiofrequency energy is delivered. This is a measure the amount of time the physician was actively applying treatment to the heart to treat the participant's heart condition.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=199 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Radiofrequency (RF) Time
|
35.9 minutes
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: During ProcedureDefined as total time subject is exposed to fluoroscopy. Fluoroscopy is a type of medical imaging that uses x-rays. This imaging is used by the physician to facilitate a safe and effective procedure. Less fluoroscopy time may help reduce the risk of issues related to x-ray exposure, however other factors such as fluroscopy intensity (not measured in this study) may also be important.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Fluoroscopy Time
|
38.7 minutes
Standard Deviation 31.2
|
SECONDARY outcome
Timeframe: During ProcedureDefined as the total cumulative mapping time and mapping time for the creation of each map (including any new or retrospective map created with Manual, AutoMap, and TurboMap mapping). As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Mapping time provides a measure of how much time the physician spent creating, updating, and analyzing maps during the procedure. A short mapping time is not necessarily better or worse than a long mapping time, as other factors such as the amount and type of information gathered may also affect how useful the map is to the physician.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Mapping Time Associated With Mapping Arrhythmia
|
76.3 minutes
Standard Deviation 63.0
|
SECONDARY outcome
Timeframe: During ProcedureDefined as total number of mapping points collected for the creation of each map. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Number of mapping points collected is a measure of how much information was collected. A small number of mapping points collected is not necessarily better or worse than a large number of points, as other factors such as the amount of time spent and type of information gathered may also affect how useful the map is to the physician.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=424 Number of Maps
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Mapping Points Collected
|
9828.8 mapping points
Standard Deviation 7192.1
|
SECONDARY outcome
Timeframe: During ProcedureDefined as the total number of mapping points used in each map. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Number of mapping points collected is a measure of how much information was collected, while number of mapping points used is a measure of how many such points were considered useful. A small number of mapping points used is not necessarily better or worse than a large number of points, as other factors such as the amount of time spent and type of information gathered may also affect how useful the map is to the physician.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=424 Mapping Points
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Mapping Points Used
|
1962.4 Mapping Points
Standard Deviation 1100.0
|
SECONDARY outcome
Timeframe: During ProcedureDefined as the total number of mapping points used divided by the relative mapping time. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity. The information in the map may be used by the physician to plan the treatment strategy. Mapping time is a measure of how much time the physician spent collecting, updating, and analyzing the information in the map. Number of mapping points collected is a measure of how much information was collected, while number of mapping points used is a measure of how many such points were considered useful. The number of used mapping points per minute is a measure of how efficient the mapping process is. A larger number of used mapping points per minute may be associated with a more efficient mapping process. Mapping efficiency may be of interest to a physician, however other factors such as the type of information gathered may also be of interest.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=424 Number of Maps
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Used Mapping Points Per Minute
|
231.7 Number of Mapping Points/Minute
Standard Deviation 126.9
|
SECONDARY outcome
Timeframe: During ProcedurePopulation: The analysis population is the number of subjects in which the substrate type was searched for
For each type of arrhythmogenic substrate this will be defined as the frequency of substrate type identified in cases that attempted to identify the specific substrate. As part of an ablation procedure to treat atrial fibrillation, some physicians create a map of the heart's electrical activity or use other tests to characterize the state, function, or health of certain areas of the heart tissue, and to localize certain areas that may be problematic (substrate). These localized characteristics may provide information to the physician that could be used to treat the participant's heart condition. This outcome measure lists common substrate characteristics and the number of subjects for which the characteristic was found or otherwise used as part of the treatment plan.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Substrate Characteristics Identified
Low Voltage
|
181 Participants
|
|
Substrate Characteristics Identified
Fibrosis/Scar
|
40 Participants
|
|
Substrate Characteristics Identified
Focal Impulses
|
1 Participants
|
|
Substrate Characteristics Identified
Rotors
|
0 Participants
|
|
Substrate Characteristics Identified
CFE
|
4 Participants
|
|
Substrate Characteristics Identified
Other
|
4 Participants
|
|
Substrate Characteristics Identified
Both Low Voltage and Fibrosis/Scar
|
40 Participants
|
SECONDARY outcome
Timeframe: During ProcedureDefined by both the type of map used to define ablation strategy and the frequency each ablation strategy/target was used by physicians. A physician may use one or more strategies to treat the participant's heart condition, including selectively burning (ablating) certain areas of the heart. This outcome measure lists common ablation strategies and the number of participants that received treatment based on each strategy.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Ablation Strategy(s) Used
Any PVI
|
200 Participants
|
|
Ablation Strategy(s) Used
PVI (Common Left)
|
110 Participants
|
|
Ablation Strategy(s) Used
PVI (Common Right)
|
100 Participants
|
|
Ablation Strategy(s) Used
PVI (LSPV)
|
93 Participants
|
|
Ablation Strategy(s) Used
PVI (LIPV)
|
92 Participants
|
|
Ablation Strategy(s) Used
PVI (RSPV)
|
98 Participants
|
|
Ablation Strategy(s) Used
PVI (RIPV)
|
99 Participants
|
|
Ablation Strategy(s) Used
Any Non-PVI
|
148 Participants
|
|
Ablation Strategy(s) Used
Eustachian Ridge
|
1 Participants
|
|
Ablation Strategy(s) Used
Mitral Isthmus
|
1 Participants
|
|
Ablation Strategy(s) Used
LAA Isolation
|
2 Participants
|
|
Ablation Strategy(s) Used
Fossa Ovalis
|
1 Participants
|
|
Ablation Strategy(s) Used
Roof
|
22 Participants
|
|
Ablation Strategy(s) Used
Christa Terminalis
|
2 Participants
|
|
Ablation Strategy(s) Used
LAA Focal Ablation
|
6 Participants
|
|
Ablation Strategy(s) Used
Coronary Sinus
|
1 Participants
|
|
Ablation Strategy(s) Used
CTI
|
127 Participants
|
|
Ablation Strategy(s) Used
Posterior Wall Isolation
|
10 Participants
|
|
Ablation Strategy(s) Used
SVC Isolation
|
26 Participants
|
|
Ablation Strategy(s) Used
Ligament of Marshall
|
23 Participants
|
|
Ablation Strategy(s) Used
Box isolation of fibrotic areas
|
4 Participants
|
|
Ablation Strategy(s) Used
CFE
|
1 Participants
|
|
Ablation Strategy(s) Used
Other
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through study completion, an average of 1 yearAdverse events include any device-, procedure-, or death-related events
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Participants With Adverse Events
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-months post-procedurePopulation: Overall Number of Participants Analyzed is the number of subjects that have either completed 12 months of follow up, or not completed 12 months of follow up but have experienced an additional ablation procedure to treat indicated cardiac arrhythmia outside of the blanking period.
Rate of repeat ablations was defined as proportion of subjects with an additional ablation procedure to treat indicated cardiac arrhythmia (outside blanking period, if applicable). This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=192 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Number of Subjects With Repeat Ablations
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-months post-procedurePopulation: The overall number of participants considered for analysis for the quality of life metrics was the 200 enrolled subjects. The number analyzed for each individual metric includes the subjects with data at both baseline and the timepoint of interest (6-months or 12-months). Of 200 enrolled subjects, 197 had available data both at baseline and 6 months. Of 200 enrolled subjects, 192 subjects had available data both at baseline and 12 months.
Defined as change in quality of life score assessed by the validated QoL survey, EQ-5D-5L. The EQ-5D-5L is a descriptive system comprised of five questions related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.
Outcome measures
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 Participants
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Change in Quality of Life (QoL): EQ-5D-5L VAS Score
VAS Score Change from Baseline to 6-months
|
6.7 score on a scale
Standard Deviation 14.3
|
|
Change in Quality of Life (QoL): EQ-5D-5L VAS Score
VAS Score Change from Baseline to 12-months
|
5.4 score on a scale
Standard Deviation 17.1
|
Adverse Events
Electroanatomical Mapping With HD Mapping Catheter
Serious adverse events
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 participants at risk
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Nervous system disorders
Cerebrovascular Accident/Stroke
|
1.0%
2/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
|
Cardiac disorders
Pericardial Effusion
|
1.0%
2/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
|
Vascular disorders
Retroperitoneal Hematoma
|
0.50%
1/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
Other adverse events
| Measure |
Electroanatomical Mapping With HD Mapping Catheter
n=200 participants at risk
Subjects underwent electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol.
|
|---|---|
|
Vascular disorders
Bleeding/Anemia
|
0.50%
1/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
|
Respiratory, thoracic and mediastinal disorders
Fever
|
0.50%
1/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
|
Vascular disorders
Vascular Access Complications
|
0.50%
1/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
|
Vascular disorders
Vascular Bleeding/Local Hematomas/Ecchymosis
|
0.50%
1/200 • 12 months
Adverse events collected were only those considered related to either the ablation catheter or the ablation procedure by the investigator or resulted in death. All-Cause Mortality: all anticipated and unanticipated deaths due to any cause. Serious Adverse Events: all anticipated and unanticipated serious adverse events related (or possibly related) to procedure or device. Other Adverse Events: anticipated and unanticipated non-serious events related to procedure or device.
|
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