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| ID | Type | Description | Link |
|---|---|---|---|
| BWI202107 | Other Identifier | Biosense Webster, Inc. |
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The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irreversible Electroporation (IRE) System | Experimental | Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation will be treated with the IRE system which includes multi-electrode circular IRE catheter and the multi-channel IRE generator. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Channel Irreversible Electroporation (IRE) Generator | Device | The multi-channel IRE Generator is intended for use during cardiac Pulsed Field Ablation (PFA) therapy. This device is used in conjunction with a compatible ablation catheter to create a closed electrical circuit capable of delivering pulsed electrical field energy. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Long-term Effectiveness | Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study. | From Day 91 up to Day 365 post-procedure on Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Primary Adverse Event (PAE) | Percentage of participants experiencing PAE were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. Primary AEs within seven days of the ablation procedure which used investigational devices per protocol, including the initial and repeat procedures were reported. PAEs included cardiac tamponade, perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischaemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, pulmonary vein stenosis, pulmonary oedema (respiratory insufficiency), vagal nerve injury/gastroparesis, pericarditis, major vascular access complication/bleeding, and atrio-esophageal fistula . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianzeng Dong | The First Affiliated Hospital of Zhengzhou University | Study Chair |
| Shaowen Liu | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Hailong Tao | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Hua Fu | West China Hospital | Principal Investigator |
| Yumei Xue | Guangdong Provincial People's Hospital | Principal Investigator |
| Heng Cai | Tianjin Medical University General Hospital | Principal Investigator |
| Lianjun Gao | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China | |||
| The first affiliated hospital of Zhengzhou University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42205100 | Derived | Tao H, Cai H, Fu H, Liu S, Chen S, Gao L, Yin X, Xue Y, Liao H, Zeng R, Cui K, Dong J. 12-Month Clinical Outcomes Using a Variable-Loop Circular Catheter for PFA in a Chinese Atrial Fibrillation Population. Pacing Clin Electrophysiol. 2026 May 28. doi: 10.1111/pace.70294. Online ahead of print. |
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Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | Irreversible Electroporation (IRE) System | Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2023 | Dec 15, 2025 |
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| Multi-Channel Circular IRE Catheter | Device | The multi-channel circular IRE Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and when used with an IRE Generator, for cardiac ablation. |
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| Within 7 days post-procedure on Day 0 |
| Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure | Percentage of participants with SAEs within 7 days (early-onset), 8-30 days (peri-procedural) and >30 days (late onset) of initial ablation procedure were reported. A SAE was any adverse event (AE) that resulted in a death or a serious deterioration in the health of the participant during the clinical trial, including a life-threatening illness or injury, a permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a body function; or resulted in fetal distress, foetal death or congenital abnormality, congenital anomaly, etc. | From day of procedure (Day 0) up to 12 months |
| Percentage of Participants With Acute Procedural Success | Percentage of participants with acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter was considered as acute procedural failure. | On the day of procedure (Day 0) |
| Percentage of Participants With Acute Reconnection | Percentage of participants with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant. | On the day of procedure (Day 0) |
| Percentage of Pulmonary Veins (PVs) With Acute Reconnection | Percentage of PVs with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant. | On the day of procedure (Day 0) |
| Percentage of Participants With Pulmonary Vein (PV) Ablation | Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported. | On day of procedure (Day 0) |
| Percentage of Participants With Repeated Ablation | Percentage of participants with repeated ablation within the 12 months follow up period, including timing (blanking period or after blanking) were reported. Repeat procedures for AF/AT/AFL of unknown origin plus recurrences during the blanking period (90 days post index procedure) were conducted with the investigational device for ablating PV reconnections. Repeat procedures performed after the blanking period were managed per investigator discretion using a commercially available ablation catheter and generator. | From the day of procedure (Day 0) up to 12 months |
| Zhengzhou |
| Henan |
| China |
| The first affiliated hospital of Dalian Medical University | Dalian | Liaoning | China |
| Shanghai General Hospital | Shanghai | Shanghai Municipality | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| Roll-in Participants |
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| Non-roll-in Participants |
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| Completed the Index Ablation Procedure |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Irreversible Electroporation (IRE) System | Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| 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 | Percentage of Participants With Long-term Effectiveness | Long-term effectiveness was defined as freedom from documented asymptomatic and symptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL; of unknown origin) episodes based on electrocardiographic data (greater than equal to [>=] 30 seconds on arrhythmia monitoring device) through the effectiveness evaluation period (Day 91 through Day 365 post index procedure) and freedom from the following failure modes : freedom from acute procedural failure, freedom from non-study catheter failure, freedom from repeat ablation failure, freedom from direct Current (DC) cardioversion failure, freedom from recurrence (captured on 12-lead electrocardiogram [ECG]) failure, and freedom from anti-arrhythmic drug failure. AFL of unknown origin was defined as all AFL except those Cavo-Tricuspid Isthmus (CTI) dependent AFL as confirmed by accepted electrophysiology (EP) maneuvers (for example, entrainment or activation mapping) in an EP study. | Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 91 up to Day 365 post-procedure on Day 0 |
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| Secondary | Percentage of Participants Experiencing Primary Adverse Event (PAE) | Percentage of participants experiencing PAE were reported. An AE is any untoward medical occurrence in a participant whether or not related to the investigational medical device. Primary AEs within seven days of the ablation procedure which used investigational devices per protocol, including the initial and repeat procedures were reported. PAEs included cardiac tamponade, perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischaemic attack, phrenic nerve injury/diaphragmatic paralysis, heart block, pulmonary vein stenosis, pulmonary oedema (respiratory insufficiency), vagal nerve injury/gastroparesis, pericarditis, major vascular access complication/bleeding, and atrio-esophageal fistula . | Safety analysis set included all the enrolled participants (including both non roll-in and roll-in participants) who had the investigational devices inserted or treated. | Posted | Number | Percentage of participants | Within 7 days post-procedure on Day 0 |
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| Secondary | Percentage of Participants Experiencing Serious Adverse Event (SAE) Within 7 Days, 8-30 Days and >30 Days of Initial Ablation Procedure | Percentage of participants with SAEs within 7 days (early-onset), 8-30 days (peri-procedural) and >30 days (late onset) of initial ablation procedure were reported. A SAE was any adverse event (AE) that resulted in a death or a serious deterioration in the health of the participant during the clinical trial, including a life-threatening illness or injury, a permanent impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a body function; or resulted in fetal distress, foetal death or congenital abnormality, congenital anomaly, etc. | Safety analysis set included all the enrolled participants (including both non roll-in and roll-in participants) who had the investigational devices inserted or treated. | Posted | Number | Percentage of participants | From day of procedure (Day 0) up to 12 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Acute Procedural Success | Percentage of participants with acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all clinically relevant targeted pulmonary veins (PVs) after adenosine/ isoproterenol challenge. Touching up with focal catheter was considered as acute procedural failure. | Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. | Posted | Number | Percentage of participants | On the day of procedure (Day 0) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Acute Reconnection | Percentage of participants with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant. | Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. | Posted | Number | Percentage of participants | On the day of procedure (Day 0) |
|
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| Secondary | Percentage of Pulmonary Veins (PVs) With Acute Reconnection | Percentage of PVs with acute reconnection were reported. Acute reconnection was identified by adenosine/isoproterenol challenge among all clinically relevant targeted PVs and by participant. | Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. | Posted | Number | Percentage of pulmonary veins | On the day of procedure (Day 0) | Pulmonary veins | Pulmonary veins |
|
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| Secondary | Percentage of Participants With Pulmonary Vein (PV) Ablation | Percentage of participants with PV ablation by a non-study catheter (touch-up) among all clinically relevant targeted participants were reported. | Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. | Posted | Number | Percentage of participants | On day of procedure (Day 0) |
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| Secondary | Percentage of Participants With Repeated Ablation | Percentage of participants with repeated ablation within the 12 months follow up period, including timing (blanking period or after blanking) were reported. Repeat procedures for AF/AT/AFL of unknown origin plus recurrences during the blanking period (90 days post index procedure) were conducted with the investigational device for ablating PV reconnections. Repeat procedures performed after the blanking period were managed per investigator discretion using a commercially available ablation catheter and generator. | Full analysis set (FAS) included all enrolled non-roll-in participants who were ablated with investigational devices. | Posted | Number | Percentage of participants | From the day of procedure (Day 0) up to 12 months |
|
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From the time of informed consent signing through 12 months post-procedure (on Day 0)
Safety analysis set included all the enrolled participants (including both non roll-in participants and roll-in participants) who had the investigational devices inserted or treated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Irreversible Electroporation (IRE) System | Participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF) and indicated for catheter ablation were treated with the IRE system which included multi-electrode circular IRE catheter and the multi-channel IRE generator. | 0 | 142 | 16 | 142 | 13 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA27.1 | Non-systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA27.1 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA27.1 | Non-systematic Assessment |
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| Generalised anxiety disorder | Psychiatric disorders | MedDRA27.1 | Non-systematic Assessment |
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| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA27.1 | Non-systematic Assessment |
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| Arteriovenous fistula | Vascular disorders | MedDRA27.1 | Non-systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA27.1 | Non-systematic Assessment |
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| Puncture site haematoma | General disorders | MedDRA27.1 | Non-systematic Assessment |
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| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA27.1 | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA27.1 | Non-systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA27.1 | Non-systematic Assessment |
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| Cataract nuclear | Eye disorders | MedDRA27.1 | Non-systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA27.1 | Non-systematic Assessment |
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| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA27.1 | Non-systematic Assessment |
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| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA27.1 | Non-systematic Assessment |
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| Device dislocation | Product Issues | MedDRA27.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA27.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA27.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA27.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA27.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA27.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA27.1 | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA27.1 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA27.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA27.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA27.1 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA27.1 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Medical Director | Janssen Research and Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2024 | Dec 15, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D018274 | Electroporation |
| D011876 | Radionuclide Generators |
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
| D055664 | Electrochemical Techniques |
| D055618 | Radiation Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| >=65 years |
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| Participants |
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| Participants |
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| Pulmonary veins |
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