Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inquiry™ AFocusII™ Double Loop | The Inquiry™ AFocus™ catheters are for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiological studies. The Inquiry™ AFocus™ catheters are for use in mapping atrial regions of the heart. |
| |
| Advisor™ HD Grid, Sensor Enabled™ | The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart with recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation | Device | Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters. | 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. | End of Procedure |
| Number of Participants With Clinical Long-Term Success | 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. | 12 months post-procedure |
| Number of Participants With AAD-Free Long-Term Success | 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. | 12-month post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Procedure Time | Defined 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. | During Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Adverse events include any device-, procedure-, or death-related events | through study completion, an average of 1 year |
| Number of Subjects With Repeat Ablations |
Inclusion Criteria:
Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
Subject is diagnosed with AF as defined by:
Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation
Exclusion Criteria:
Not provided
Not provided
The analysis population used for all endpoints will include all subjects who have signed the Informed Consent Form and have undergone the electroanatomical mapping procedure using one of the specified HD mapping catheters and received RF ablation as specified in the protocol. If any device used during the procedure is used off-label, the subject will be excluded from non-safety related endpoint analysis and any additional evaluations
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kristin Ruffner, PhD | EP Program Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital | Hangzhou | China | ||||
| The Second Affiliated Hospital of Xian Jiaotong University |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Consented to Completed Procedure |
|
| ||||||||||||||||||
| Completed 12-month Follow-up |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters. | 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. | Posted | Count of Participants | Participants | End of Procedure |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular Accident/Stroke | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding/Anemia | Vascular disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Scientist Clinical Research | Abbott | 1 202 253 5981 | eric.horvath@abbott.com |
Not provided
| 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 6, 2019 | Aug 2, 2022 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiofrequency (RF) Time |
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. |
| During Procedure |
| Fluoroscopy Time | Defined 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. | During Procedure |
| Mapping Time Associated With Mapping Arrhythmia | Defined 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. | During Procedure |
| Number of Mapping Points Collected | Defined 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. | During Procedure |
| Number of Mapping Points Used | Defined 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. | During Procedure |
| Number of Used Mapping Points Per Minute | Defined 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. | During Procedure |
| Substrate Characteristics Identified | 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. | During Procedure |
| Ablation Strategy(s) Used | Defined 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. | During Procedure |
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.
| 12-months post-procedure |
| Change in Quality of Life (QoL): EQ-5D-5L VAS Score | 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. | 12-months post-procedure |
| Xi'an |
| China |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | 802-8555 | Japan |
| University of Tsukuba Hospital | Tsukuba | Ibaraki | 305-8576 | Japan |
| Yokosuka Kyosai Hospital | Kanagawa | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Ogaki Municipal Hospital | Ōgaki | Japan |
| Saga University Hospital | Saga | Japan |
| Kitasato University Hospital | Sagamihara | Japan |
| Kyorin University Hospital | Tama | Japan |
| Korea University Anam Hospital | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Taipei Veterans General Hospital (VGH) | Taipei | Taiwan |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | No baseline height from one subject. | Mean | Standard Deviation | centimeters |
|
| Weight | No baseline weight from one subject. | Mean | Standard Deviation | kilograms |
|
| Heart Rate on ECG | No Heart rate on ECG data at baseline for 5 subjects. | Mean | Standard Deviation | bpm |
|
| Rhythm on ECG | Rhythm on ECG is only available for 196/200 enrolled subjects. | Count of Participants | Participants |
|
| History of Heart Failure | 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). | Count of Participants | Participants |
|
| Cardiomyopathy | Count of Participants | Participants |
|
| Valvular Heart Disease | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Stroke/TIA/Thromboembolism | No history of stroke/TIA/thromboembolism collected at baseline for 4 subjects. | Count of Participants | Participants |
|
| Conduction Disease | Count of Participants | Participants |
|
| Arrhythmia History | Count of Participants | Participants |
|
| Indication for this procedure | Count of Participants | Participants |
|
| History of Class I or III AAD use | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants With Clinical Long-Term Success | 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. | Overall Number of Participants Analyzed is the number of subjects that have completed a 24-hour Holter at 12 months. | Posted | Count of Participants | Participants | 12 months post-procedure |
|
|
|
| Primary | Number of Participants With AAD-Free Long-Term Success | 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. | 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. | Posted | Count of Participants | Participants | 12-month post-procedure |
|
|
|
| Secondary | Overall Procedure Time | Defined 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. | Posted | Mean | Standard Deviation | minutes | During Procedure |
|
|
|
| Secondary | Radiofrequency (RF) Time | 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. | Overall Number of Participants Analyzed is the number of subjects with available data for this outcome. | Posted | Mean | Standard Deviation | minutes | During Procedure |
|
|
|
| Secondary | Fluoroscopy Time | Defined 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. | Posted | Mean | Standard Deviation | minutes | During Procedure |
|
|
|
| Secondary | Mapping Time Associated With Mapping Arrhythmia | Defined 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. | Posted | Mean | Standard Deviation | minutes | During Procedure |
|
|
|
| Secondary | Number of Mapping Points Collected | Defined 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. | Posted | Mean | Standard Deviation | mapping points | During Procedure | Number of Maps | Number of Maps |
|
|
|
| Secondary | Number of Mapping Points Used | Defined 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. | Posted | Mean | Standard Deviation | Mapping Points | During Procedure | Mapping Points | Mapping Points |
|
|
|
| Secondary | Number of Used Mapping Points Per Minute | Defined 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. | Posted | Mean | Standard Deviation | Number of Mapping Points/Minute | During Procedure | Number of Maps | Number of Maps |
|
|
|
| Secondary | Substrate Characteristics Identified | 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. | The analysis population is the number of subjects in which the substrate type was searched for | Posted | Count of Participants | Participants | During Procedure |
|
|
|
| Secondary | Ablation Strategy(s) Used | Defined 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. | Posted | Count of Participants | Participants | During Procedure |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events | Adverse events include any device-, procedure-, or death-related events | Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
|
| Other Pre-specified | Number of Subjects With Repeat Ablations | 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. | 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. | Posted | Count of Participants | Participants | 12-months post-procedure |
|
|
|
| Other Pre-specified | Change in Quality of Life (QoL): EQ-5D-5L VAS Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12-months post-procedure |
|
|
|
| 0 |
| 200 |
| 5 |
| 200 |
| 5 |
| 200 |
| Pericardial Effusion | Cardiac disorders | Systematic Assessment |
|
| Retroperitoneal Hematoma | Vascular disorders | Systematic Assessment |
|
| Fever | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Vascular Access Complications | Vascular disorders | Systematic Assessment |
|
| Vascular Bleeding/Local Hematomas/Ecchymosis | Vascular disorders | Systematic Assessment |
|
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.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
|
| Focal Impulses |
|
|
| Rotors |
|
|
| CFE |
|
|
| Other |
|
|
| Both Low Voltage and Fibrosis/Scar |
|
|
| Title | Measurements |
|---|---|
|
| PVI (LSPV) |
|
| PVI (LIPV) |
|
| PVI (RSPV) |
|
| PVI (RIPV) |
|
| Any Non-PVI |
|
| Eustachian Ridge |
|
| Mitral Isthmus |
|
| LAA Isolation |
|
| Fossa Ovalis |
|
| Roof |
|
| Christa Terminalis |
|
| LAA Focal Ablation |
|
| Coronary Sinus |
|
| CTI |
|
| Posterior Wall Isolation |
|
| SVC Isolation |
|
| Ligament of Marshall |
|
| Box isolation of fibrotic areas |
|
| CFE |
|
| Other |
|
|