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To obtain data for the Rhythmiaâ„¢ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
STUDY OBJECTIVE(S) -- To obtain data for the Rhythmiaâ„¢ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
PRIMARY OBJECTIVE -- To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
INDICATION(S) FOR USE -- Study devices will be used per approved Indications for Use for each geography.
DEVICES / SYSTEM USED IN THE STUDY -- The study will include the following Boston Scientific Open-Irrigated Catheters in geographies where commercially approved for PAF ablation:
CONTROL DEVICE -- There are no control devices in this study
STUDY DESIGN -- Prospective, non-randomized, multicenter (global), post approval clinical study (PAS). All subjects fitting the enrollment criteria, signing the consent and undergoing the index procedure with the study devices will be followed up for three years to complete the PAS design mandated from the FDA to collect post-market data for Boston Scientific Open-Irrigated Catheters and will be followed for three years.
PLANNED NUMBER OF SUBJECTS -- The study will enroll 415 subjects.
PLANNED NUMBER OF SITES / COUNTRIES -- The study is global (US, EU, Asia-Pacific) with 25-50 centers. A minimum of 50% of the sites will be selected from the US. No study site will be allowed to contribute more than 41 subjects (10% of the 415 enrollments requirement).
FOLLOW-UP SCHEDULE -- Study Follow-ups are at: pre-discharge, 1 month (phone check), 3 months (blanking period), 6 months (phone check), 12 months, 24 months and 36 months.
STUDY DURATION -- Study is expected to be completed in approximately five years (12-24 month enrollment period with three year follow-up).
PARTICIPANT DURATION -- The study duration for each subject is expected to be approximately three years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Open Irrigated Ablation Catheters | Device | The BSC Open-Irrigated catheters are designed to deliver RF energy to catheter tip electrode for cardiac ablation. The BSC OI catheters incorporate an open-irrigated cooling mechanism through a tip that is partitioned into two chambers. The proximal chamber circulates normal saline (0.9 %) within the tip to cool the proximal electrode and mitigate overheating while the distal chamber allows the fluid to flow through six irrigation holes into the patient's vasculature, thereby cooling the tip/tissue interface. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Safety Event-free at 12 Months Post Procedure | This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following:
Chronic primary safety endpoint events are defined as the following occurring through: 3 Months post-procedure 12 Months post-procedure
| 12 months |
| Number of Participants Effectiveness Event -Free at 12 Months Post Procedure | The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure. Primary effectiveness events are defined as:
| 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Event Free Rate (Secondary) | The secondary effectiveness endpoint is defined as the event-free at 12 months post-procedure. Secondary effectiveness events are defined as:
|
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Inclusion Criteria:
Exclusion Criteria:
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Subjects included in the INTERRUPT AF study should be selected from the investigator's general patient population indicated for catheter ablation of PAF.
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| Name | Affiliation | Role |
|---|---|---|
| Oussama Wazni | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Torrance Memorial Medical Center |
No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
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| ID | Title | Description |
|---|---|---|
| FG000 | INTERRUPT AF Clinical Study | Patients who underwent treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System Devices/Systems used in the study: Boston Scientific Open-Irrigated Catheters:
|
| 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 | Feb 12, 2019 | Oct 1, 2025 |
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| 12 Months |
| Torrance |
| California |
| 90505 |
| United States |
| Broward General Medical Center | Miami | Florida | 33136 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| St. Lukes Idaho Cardiology Associates | Boise | Idaho | 83712 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| St. John's Hospital | Springfield | Illinois | 62769 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Nebraska Heart Institute | Lincoln | Nebraska | 68526 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756-1000 | United States |
| Catholic Medical Center | Manchester | New Hampshire | 03102 | United States |
| Kaleida Health | Buffalo | New York | 14213 | United States |
| Bethesda North Hospital | Cincinnati | Ohio | 45220 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| HeartPlace Mid-Cities EP | Bedford | Texas | 76021 | United States |
| Orion Medical | Pasadena | Texas | 77505 | United States |
| Christus Trinity Mother Frances Health System | Tyler | Texas | 75701 | United States |
| Staedtisches Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |
| Juedisches Krankenhaus Berlin | Mitte | 13347 | Germany |
| Kokura Memorial Hospital | Fukuoka-ken | 802-8555 | Japan |
| Yokosuka Kyosai Hospital | Kanagawa Prefecture | 238-8558 | Japan |
| Centre Hospitalier Princesse Grace | Monaco | 98000 | Monaco |
| Keimyung University Dongsan Medical Center | Daegu | 42601 | South Korea |
| Korea University Medical Center | Seoul | 2841 | South Korea |
| Papworth Hospital | Cambridge | CB2 0AY | United Kingdom |
| Procedure |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | INTERRUPT AF Clinical Study | Patients who underwent treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System Devices/Systems used in the study: Boston Scientific Open-Irrigated Catheters:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex: Female, Male | 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information | Count of Participants | Participants |
| |||||||||||||||||
| Race/Ethnicity, Customized | Race not reported for 8 subjects | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Weight not reported for 2 subjects | Mean | Standard Deviation | kg |
| ||||||||||||||||
| Height | Height not reported for 2subjects | Mean | Standard Deviation | cm |
| ||||||||||||||||
| BMI | BMI not reported for 2 subjects | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Resting Systolic BP | Resting systolic BP not reported for 3 subjects | Mean | Standard Deviation | mmHG |
| ||||||||||||||||
| Resting Diastolic BP | Resting diastolic BP not reported for 3 subjects | Mean | Standard Deviation | mmHG |
| ||||||||||||||||
| Resting Heart Rate | Resting heart rate not reported for 3 subjects | Mean | Standard Deviation | bpm |
| ||||||||||||||||
| Cardiac Non-Arrhythmic | Participants can be counted more than once in the appropriate category. | Count of Participants | Participants |
| |||||||||||||||||
| Cardiac Procedure History | 414 analyzed instead of 415 as 1 patient withdrew from the study prior to providing this information | Count of Participants | Participants |
| |||||||||||||||||
| Noncardiac Comorbidities | Participants can be counted more than once in the appropriate category. | Count of Participants | Participants |
| |||||||||||||||||
| Arrhythmia History | Participants can be counted more than once in the appropriate category. | Arrhythmia history not reported for 3 patients | Count of Participants | Participants |
|
| 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 Safety Event-free at 12 Months Post Procedure | This measure reports the observed safety event -free rate at 12 Months follow up. The safety events are a composite of acute primary safety events (events occurring within seven days post-procedure or hospital discharge, whichever is later), and chronic primary safety events (events occurring through 3- or 12-months post-procedure, as listed below). Acute primary safety endpoint events are defined as the following:
Chronic primary safety endpoint events are defined as the following occurring through: 3 Months post-procedure 12 Months post-procedure
| This analysis includes all treatment and attempt subjects, including those with missing data. | Posted | Number | Number of Participants | 12 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants Effectiveness Event -Free at 12 Months Post Procedure | The primary effectiveness endpoint is defined as the event-free rate at 12 months post-procedure. Primary effectiveness events are defined as:
| Posted | Number | Number of Participants | 12 Months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants Event Free Rate (Secondary) | The secondary effectiveness endpoint is defined as the event-free at 12 months post-procedure. Secondary effectiveness events are defined as:
| Posted | Count of Participants | Participants | 12 Months |
|
12 months
There is only one arm in the study- Treatment Arm (383 subjects). Intent subjects (32) are not considered a study arm Consented subjects= 415
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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 | Treatment With Ablation Catheter | Patients who undergo treatment with a Boston Scientific open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation in conjunction with the Rhymthia Mapping System Treatment with Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Ablation Catheter, or IntellaTip MiFi Open-Irrigated Ablation Catheter: Patients will be treated with an ablation catheter | 5 | 383 | 135 | 383 | 46 | 383 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure related general adverse reaction | Surgical and medical procedures | Systematic Assessment |
| ||
| Angina/Chest pain | Surgical and medical procedures | Systematic Assessment |
| ||
| Hematological | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Aortic stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter, not specified | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT) | Cardiac disorders | Systematic Assessment |
| ||
| Atrial tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Atypical (Type II) Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea - Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Exacerbation of pre-existing condition | Cardiac disorders | Systematic Assessment |
| ||
| Heart failure symptoms - Unspecified | Cardiac disorders | Systematic Assessment |
| ||
| Mitral regurgitation | Cardiac disorders | Systematic Assessment |
| ||
| Mitral stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Multiple heart failure symptoms | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Peripheral edema - Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Premature Ventricular Contractions (PVC) | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Tachy-brady syndrome | Cardiac disorders | Systematic Assessment |
| ||
| Tachyarrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular Tachycardia (VT)/Monomorphic VT | Cardiac disorders | Systematic Assessment |
| ||
| Endocrine | Endocrine disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abnormal laboratory values | General disorders | Systematic Assessment |
| ||
| Adverse reaction - Medication | General disorders | Systematic Assessment |
| ||
| Chest pain - Other | General disorders | Systematic Assessment |
| ||
| Death | General disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Head, eyes, ears, nose, throat (HEENT) | General disorders | Systematic Assessment |
| ||
| Panniculectomy | General disorders | Systematic Assessment |
| ||
| Physical trauma | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| bleeding from hemodialysis site | General disorders | Systematic Assessment |
| ||
| Infection - Unrelated (non study) procedure or device | Infections and infestations | Systematic Assessment |
| ||
| Systemic infection | Infections and infestations | Systematic Assessment |
| ||
| Adverse reaction - Abnormal labs - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Anesthesia/Sedation - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Hypertension - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Hypotension - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Neurological (non-TIA, non-stroke) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Pulmonary - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Conduction pathway injury (pacemaker implantation) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Exacerbation of existing condition - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Major bleeding/hemorrhage requiring transfusion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Myocardial perforation with tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other - Unrelated (non study) procedure or device (ICD EOL) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other - Unrelated (non study) procedure or device (LV Lead revision) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Other - Unrelated (non study) procedure or device (RV Lead revision) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericardial effusion - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericarditis - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pleural Effusion - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post-surgical infection/sepsis - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pseudoaneurysm - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stroke (ischemic) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Transient Ischemic Attack (TIA) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Neurological | Nervous system disorders | Systematic Assessment |
| ||
| Elevated threshold - RA Lead | Product Issues | Systematic Assessment |
| ||
| Oversensing - RV PG System | Product Issues | Systematic Assessment |
| ||
| Genitourinary | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal | Renal and urinary disorders | Systematic Assessment |
| ||
| Pulmonary | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Adverse reaction - Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Cerebrovascular Accident (CVA) - unspecifed | Vascular disorders | Systematic Assessment |
| ||
| Coronary Artery Disease | Vascular disorders | Systematic Assessment |
| ||
| Distal thromboemboli | Vascular disorders | Systematic Assessment |
| ||
| Edema | Vascular disorders | Systematic Assessment |
| ||
| Hematoma - Unrelated (non study) procedure or device | Vascular disorders | Systematic Assessment |
| ||
| Hypertension/Hypertensive Crisis | Vascular disorders | Systematic Assessment |
| ||
| Hypotension/Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Myocardial infarction | Vascular disorders | Systematic Assessment |
| ||
| Pseudoaneurysm with hematoma | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary Embolism (PE) | Vascular disorders | Systematic Assessment |
| ||
| Transient Ischemic Attack (TIA) | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse reaction - General - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Angina/Chest pain - Post EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Puncture site hematoma - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Vasospasm - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Atrial Fibrillation (AF) | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter, not specified | Cardiac disorders | Systematic Assessment |
| ||
| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
| ||
| Gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
| ||
| Head, eyes, ears, nose, throat (HEENT) | General disorders | Systematic Assessment |
| ||
| Syncope | General disorders | Systematic Assessment |
| ||
| Adverse reaction - Abnormal labs - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Anesthesia/Sedation - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Gastrointestinal - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Genitourinary/Renal - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Adverse reaction - Neurological (non-TIA, non-stroke) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Angina/Chest pain - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Embolism - Air - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Exacerbation of existing condition - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hematoma - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Inadvertent injury to adjacent structure - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Minor oozing/bleeding - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pain (non-cardiovascular) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pericarditis - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post-surgical wound discomfort - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Stroke (ischemic) - EP procedure | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Ablation-EP Related~Other | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Hampson, Clinical Trial Manager | Boston Scientific | 508-728-5165 | susan.hampson@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2020 | May 2, 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 |
Not provided
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| Male |
|
| Black |
|
| Hispanic or Latino |
|
| Asian |
|
| Race Not Disclosed |
|
|
| United States |
|
|
| Japan |
|
|
| United Kingdom |
|
|
| Germany |
|
|
| Cardiomyopathy |
|
|
| Valvular Disease |
|
|
| Coronary Artery Disease |
|
|
| Cardiac Disease Other |
|
|
| Congestive Heart Failure |
|
|
| Cerebrovascular Disease |
|
|
| Peripheral Vascular Disease |
|
|
| Hypertension |
|
|
| Pulmonary Hypertension |
|
|
| Hyperlipidemia |
|
|
| Coagulopathy - Hypercoagulable State - Clotting Disorder |
|
|
| Transient Ischemic Attack (TIA) CVA or PE |
|
|
| Cardiac thrombus |
|
|
| Other cardiovascular disease occurred |
|
|
| No history of cardiac disease |
|
|
| Cardiac ablations |
|
| None |
|
| Diabetes |
|
|
| Hepatic Disease |
|
|
| Neurological Disease |
|
|
| Renal Disease |
|
|
| GI Bleeding |
|
|
| Sleep Disordered Breathing |
|
|
| Other comorbidities |
|
|
| Non-study hospitalization |
|
|
| None |
|
|
| No Ventricular Arrhythmias |
|
|
| Atrial Arrhythmia Occurred |
|
|
| No Atrial Arrhythmias |
|
|
| ORT or AVRT |
|
|
| Focal Atrial Tachycardia |
|
|
| Accessory Pathway |
|
|
| Paroxysmal Atrial Fibrillation |
|
|
| Atrial Tachycardia |
|
|
| Atrial Flutter |
|
|
| Atrial Arrhythmia Other |
|
|
| Brady Arrhythmia Occurred |
|
|
| Sinus Bradycardia |
|
|
| Sinus Node Dysfunction |
|
|
| Sick Sinus Syndrome Chronotropic Incompetence |
|
|
| Sinus arrest |
|
|
| AV Block 1 |
|
|
| AV Block 2 |
|
|
| Brady Arrhythmia Other |
|
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|