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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| The Cleveland Clinic | OTHER |
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To evaluate the safety and effectiveness of the left atrial appendage occlusion with WATCHMAN Device in prevention of stroke and bleeding in patients with atrial fibrillation (AF) undergoing transcatheter aortic valve replacement (TAVR).
WATCH-TAVR is a prospective, multicenter, randomized controlled trial. Only centers with approval for commercial WATCHMAN implantation will be included in this trial. Subjects will be enrolled at up to 32 centers in the United States. There will be up to 350 subjects enrolled, with 175 patients randomized to TAVR + medical therapy and 175 patients randomized to simultaneous TAVR+WATCHMAN to accumulate the necessary 191 primary events. Enrollment is expected to occur over the course of 18 months. Patients will be followed for a total of 2 years. Patients with non-valvular AF undergoing standard of care commercial TAVR will be enrolled in the trial.
For patients who receive the WATCHMAN device, plan of care will follow WATCHMAN labeling.Patients randomized to receive the WATCHMAN device will receive anticoagulation with warfarin and aspirin for 6 weeks after the procedure. After 6 weeks, the plan of care will follow WATCHMAN labeling. Patients randomized to the TAVR + medical therapy arm will be treated in accordance with standard of care with either warfarin, other anticoagulant/antiplatelet therapy, or no anticoagulation at the discretion of the treating physician. All patients will continue to receive routine post-TAVR follow-up and care.Patients will be monitored for primary and secondary endpoints as outlined. Baseline information and laboratory data will be collected as described in the protocol.
At trial conclusion, total number of subjects enrolled was 349. There were 172 subjects enrolled in the TAVR + Medical Therapy arm and 177 subjects enrolled in the TAVR + WATCHMAN arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR + Medical Therapy | Active Comparator | n=172 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation |
|
| TAVR + WATCHMAN | Experimental | n=177 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WATCHMAN | Device | WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of All-cause Mortality, Stroke and Bleeding | First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization. | Through 2 year post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | All deaths through 2 year | Through 2 year post-randomization |
| Stroke | First occurrence of any ischemic or hemorrhagic stroke through 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular Mortality | Cardiovascular related mortality through 2 year | Through 2 year post-randomization |
| Thrombus or Embolism | Incidence of arterial or venous embolism |
Inclusion Criteria:
Exclusion Criteria:
3 .Moderate or severe Mitral Stenosis with mean gradient across Mitral Valve >10 mm Hg or Mitral Valve Area < 1.2cm2.
4. The patient has symptomatic carotid disease (i.e.,carotid stenosis ≥ 50% associated with ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months).
5. Prior occlusion of LAA.
6. The patient has an implanted mechanical mitral valve.
7. The patient requires long-term warfarin therapy due to:
Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months
The patient is in a hypercoaguable state; exclude the patient if per medical record documentation, the patient meets any of the following criteria:
Thrombosis occurring ≤ 40 years of age
Idiopathic or recurrent VTE (venous thrombo-embolism)
Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins)
Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anticoagulated.
8. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable).
9. The patient is pregnant or pregnancy is planned during the course of the investigation if patient is of child bearing potential.
10. Any clinically significant medical condition or presence of any laboratory abnormality prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or WATCHMAN.
11. The patient has a life expectancy of less than two years.
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| Name | Affiliation | Role |
|---|---|---|
| Samir Kapadia, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Sutter Health/Palo Alto Medical Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37874908 | Derived | Kapadia SR, Krishnaswamy A, Whisenant B, Potluri S, Iyer V, Aragon J, Gideon P, Strote J, Leonardi R, Agarwal H, Larrain G, Sanchez C, Panaich SS, Harvey J, Vahl T, Menon V, Wolski K, Wang Q, Leon MB. Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement Among Patients With Atrial Fibrillation. Circulation. 2024 Mar 5;149(10):734-743. doi: 10.1161/CIRCULATIONAHA.123.067312. Epub 2023 Oct 24. |
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General study population consisted of patients having non-valvular Atrial Fibrillation undergoing standard of care TAVR. Recruitment started December 2017 with the final subject enrolled November 2020. Only medical centers with approval for commercial WATCHMAN implantation were included in this trial. There were 34 North American sites in the WATCH TAVR trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAVR + Medical Therapy | n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation TAVR: Transcatheter Aortic Valve Replacement |
| FG001 | TAVR + WATCHMAN |
| 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 | Jul 9, 2020 | Jan 9, 2024 |
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Patients will be randomized in a 1:1 allocation ratio to the following treatment arms TAVR + Medical Therapy (n=175) or simultaneous TAVR + WATCHMAN (n=175)
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| TAVR | Device | Transcatheter Aortic Valve Replacement |
|
| Through 2 year post-randomization |
| Bleeding | First occurrence of any life-threatening or major bleeding through 2 year | Through 2 year post-randomization |
| Through 2 year post-randomization |
| Re-hospitalization | Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device | Through 2 year post-randomization |
| Quality of Life Score: KCCQ-12 | Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status. | Through 2 year post-randomization |
| Procedural Costs | Procedural costs related to the initial TAVR and WATCHMAN procedures | Mean cost during hospitalization up to 40 days. |
| Burlingame |
| California |
| 94010 |
| United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| UCHealth Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Baptist Health Jacksonville | Jacksonville | Florida | 32207 | United States |
| Northside Hospital | St. Petersburg | Florida | 33709 | United States |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | United States |
| Prairie Cardiovascular Consultants | Springfield | Illinois | 62701 | United States |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | United States |
| St. Vincent Heart Center | Indianapolis | Indiana | 46290 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | United States |
| Medstar Washington University | St Louis | Missouri | 63110 | United States |
| CHI Health Research Center | Omaha | Nebraska | 68124 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| University at Buffalo | Buffalo | New York | 14203 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| Pinnacle Health | Wormleysburg | Pennsylvania | 17043 | United States |
| WellSpan York Hospital | York | Pennsylvania | 17403 | United States |
| Lexington Cardiology | West Columbia | South Carolina | 29169 | United States |
| Austin Heart | Austin | Texas | 78756 | United States |
| Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Aspirus Research Institute | Wausau | Wisconsin | 54401 | United States |
n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device.
WATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.
TAVR: Transcatheter Aortic Valve Replacement
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants in number
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| ID | Title | Description |
|---|---|---|
| BG000 | TAVR + Medical Therapy | n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation TAVR: Transcatheter Aortic Valve Replacement |
| BG001 | TAVR + WATCHMAN | n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device. WATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium. TAVR: Transcatheter Aortic Valve Replacement |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | Composite of All-cause Mortality, Stroke and Bleeding | First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization. | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality | All deaths through 2 year | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Stroke | First occurrence of any ischemic or hemorrhagic stroke through 2 year | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
| |||||||||||||||||||||||||||||||
| Secondary | Bleeding | First occurrence of any life-threatening or major bleeding through 2 year | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Cardiovascular Mortality | Cardiovascular related mortality through 2 year | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Thrombus or Embolism | Incidence of arterial or venous embolism | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Re-hospitalization | Incidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device | Posted | Count of Participants | Participants | Through 2 year post-randomization |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Quality of Life Score: KCCQ-12 | Change from baseline in quality of life (QoL) as measured using the KCCQ-12 score. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool used to assess heart failure and how it affects the participant's life. Four domain scores and one summary score are generated from the KCCQ-12: Physical Limitation Score, Symptom Frequency Score, Quality of Life Score, Social Limitation Score and a Summary Score. Scale ranges for each question 1 to 6 (Extremely limited 1, Quite a bit limited 2, Moderately limited 3, Slightly limited 4, Not at all limited 5, Limited for other reasons or did not do the activity 6. The Summary score represents an integration of the patient's physical limitation, symptom frequency, quality of life and social limitation. The total score is calculated as the average of the above scale descriptions. Scores are scaled 0-100, where 0 denotes the lowest reportable health status. Scores of 100 indicate the highest reportable health better outcome status. | Patient's with non missing KCCQ data | Posted | Mean | Standard Deviation | score on a scale | Through 2 year post-randomization |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Procedural Costs | Procedural costs related to the initial TAVR and WATCHMAN procedures | Sites willing to provide cost data. | Posted | Mean | Standard Deviation | dollars | Mean cost during hospitalization up to 40 days. |
|
|
Events collected within two years following randomization.
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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 | TAVR + Medical Therapy | n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation TAVR: Transcatheter Aortic Valve Replacement | 39 | 172 | 90 | 172 | 131 | 172 |
| EG001 | TAVR + WATCHMAN | n=175 will undergo simultaneous Transcatheter Aortic Valve Replacement (TAVR) with a WATCHMAN device. WATCHMAN: WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium. TAVR: Transcatheter Aortic Valve Replacement | 37 | 177 | 87 | 177 | 127 | 177 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac - Other | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Bleeding - Event Associated with bleeding | Blood and lymphatic system disorders | VARC 2 definitions | Non-systematic Assessment | Event associated with bleeding |
|
| Cardiac - Heart Failure | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Heart Failure |
|
| Renal - Other (not bleeding) | Renal and urinary disorders | VARC 2 definitions | Non-systematic Assessment | Other- not bleeding |
|
| Infection - Other (except endocarditis and device infection) | Infections and infestations | VARC 2 definitions | Non-systematic Assessment | Other (except endocarditis and device infection) |
|
| Cardiac - Sudden Cardiac Death/Cardiac Arrest | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Sudden Cardiac Death/Cardiac Arrest |
|
| Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | VARC 2 definitions | Non-systematic Assessment | Not associated with bleeding |
|
| Cancer/Malignancy | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Respiratory Failure | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Neurologic - Ischemic Stroke | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Pleural Effusion | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment | Pleural Effusion (not sanguineous) |
|
| Neurologic - Other | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Other |
|
| Neurologic - Stroke Type Unknown | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Stroke Type Unknown |
|
| Trauma | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Renal - AKI (requiring dialysis) | Renal and urinary disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Pericardial Effusion (not hemorrhagic) | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Pericardial Effusion (not hemorrhagic) |
|
| COVID-19 Infection | Infections and infestations | VARC 2 definitions | Non-systematic Assessment |
| |
| Rehospitalization related to TAVR device or procedure | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Infection - UTI | Infections and infestations | VARC 2 definitions | Non-systematic Assessment | UTI |
|
| Thrombosis - Other systemic | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Other systemic (other than stroke) |
|
| GI- Other (not bleeding) | Gastrointestinal disorders | VARC 2 definitions | Non-systematic Assessment | Other (not bleeding) |
|
| Cardiac - Endocarditis | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| COD Unknown | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Embolism | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment | Embolism |
|
| Neurologic - TIA | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | TIA |
|
| Cardiac - Myocardial Infarction | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment | Other |
|
| Cardiac - AV Regurgitation/Leak | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | AV Regurgitation/Leak |
|
| Thrombosis - WATCHMAN Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | WATCHMAN Device |
|
| Thrombus- Atrial (not arterial) | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Atrial (not arterial) |
|
| Septic Shock | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Endocrine Disorders | Endocrine disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Angina/Chest Pain/CAD | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Pneumonia | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment | Pneumonia |
|
| Pulmonary - COPD | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment | COPD |
|
| Neurologic - Subdural Hematoma | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Vascular Pseudoaneurysm | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Requires endovascular repair |
|
| Vascular AV Fistula (intervention required) | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Neruo- Mental Status Changes/Confusion (not stroke or TIA) | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Mental Status Changes/Confusion (not stroke or TIA) |
|
| Cardiac - Heart Valve Damage | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Thrombosis - Venous (including DVT) | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Venous (including DVT) |
|
| Thrombosis - TAVR Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | TAVR Device |
|
| Thrombosis - Other NON Cardiac Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Other NON Cardiac Device |
|
| Hypokalemia | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Supra-therapeutic INR | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Hepatobiliary (not bleeding) | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Rehospitalization related to WATCHMAN procedure or device (not listed above) | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Device Embolization - Catheter Retrieval | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Heart Valve Damage | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Heart Valve Damage |
|
| Thrombosis- Venous (including DVT) | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Venous (including DVT) |
|
| Thrombosis - TAVR Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Rehospitalization related to WATCHMAN procedure or device | General disorders | VARC 2 definitions | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | VARC 2 definitions | Non-systematic Assessment | Event Associated with bleeding |
|
| Cardiac - Other | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Cardiac- Other |
|
| Rental | Renal and urinary disorders | VARC 2 definitions | Non-systematic Assessment | Other- not bleeding |
|
| Trauma | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Infection | Infections and infestations | VARC 2 definitions | Non-systematic Assessment | Other (except endocarditis and device infection) |
|
| Anemia | Blood and lymphatic system disorders | VARC 2 definitions | Non-systematic Assessment | Not associated with bleeding |
|
| Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure | General disorders | VARC 2 definitions | Non-systematic Assessment | Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure |
|
| Neurologic | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Other |
|
| Infection - UTI | Renal and urinary disorders | VARC 2 definitions | Non-systematic Assessment | UTI |
|
| Cancer/Malignancy | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Sudden Cardiac Death/Cardiac Arrest | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Cardiac - Sudden Cardiac Death/Cardiac Arrest |
|
| Neurologic - Ischemic Stroke | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Ischemic Stroke |
|
| Neurologic - TIA | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | TIA |
|
| Pulmonary - Respiratory Failure | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Other | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Angina/Chest Pain/CAD | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Angina/Chest Pain/CAD |
|
| Pulmonary - Pleural Effusion | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment | Pleural Effusion (not sanguineous) |
|
| COVID-19 Infection | Infections and infestations | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Pneumonia | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| COD Unknown | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Pericardial Effusion (not hemorrhagic) | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Pericardial effusion (not hemorrhagic) |
|
| Neurologic - Stroke Type Unknown | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Stroke Type Unknown |
|
| Neurologic - Mental Status Changes/Confusion | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment | Mental Status Changes/Confusion (not stroke or TIA) |
|
| Thrombosis - Venous (including DVT) | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Venous (including DVT) |
|
| Renal- AKI (requiring dialysis) | Renal and urinary disorders | VARC 2 definitions | Non-systematic Assessment | AKI (requiring dialysis) |
|
| Rehospitalization related to TAVR device or procedure (not listed) | General disorders | VARC 2 definitions | Non-systematic Assessment | Related to TAVR device or procedure (not listed) |
|
| Thrombus - Atrial (not arterial) | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Endocarditis | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| GI- Other (not bleeding) | Gastrointestinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Myocardial Infarction | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Myocardial infarction |
|
| Thrombosis - Other Systemic (other than stroke) | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Hypokalemia | Blood and lymphatic system disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Endocrine Disorders | Endocrine disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Pulmonary - Embolism | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Neurologic - Subdural Hematoma | Nervous system disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - AV Regurg/Leak | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Vascular Pseudoaneurysm | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | no intervention required |
|
| Thrombosis - WATCHMAN Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Atrial Septal Defect (latrogenic) | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Atrial Septal Defect (latrogenic) |
|
| Device Embolization - Catheter Retrieval | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Catheter Retrieval |
|
| Pulmonary - COPD | Respiratory, thoracic and mediastinal disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Vascular Pseudoaneurysm | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | requires endovascular repair |
|
| Vascular AV Fistual | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | intervention required |
|
| Neoplasm Benign & Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | VARC 2 definitions | Non-systematic Assessment | Incl Cysts and Polyps |
|
| Leukocytosis | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Cardiac - Heart Valve Damage | Cardiac disorders | VARC 2 definitions | Non-systematic Assessment | Heart Valve Damage |
|
| Inflammatory/Immunologic | Infections and infestations | VARC 2 definitions | Non-systematic Assessment |
| |
| Thrombosis - TAVR Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Vascular AV Fistula | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | no intervention required |
|
| Thrombosis - Other NON Cardiac Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment | Other NON Cardiac Device |
|
| Thrombosis - Other Cardiac Device | Vascular disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Supra-therapeutic INR | General disorders | VARC 2 definitions | Non-systematic Assessment |
| |
| Hepatobiliary (not bleeding) | Hepatobiliary disorders | VARC 2 definitions | Non-systematic Assessment | not bleeding |
|
| Rehospitalization related to WATCHMAN procedure or device | General disorders | VARC 2 definitions | Non-systematic Assessment | Related to WATCHMAN procedure or device |
|
| Pancreatic | Gastrointestinal disorders | VARC 2 definitions | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samir Kapadia, MD Chairman Cardiovascular Medicine | Cleveland Clinic | 216 444-6735 | KAPADIS@ccf.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2023 | Jan 9, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2020 | Jan 9, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
Not provided
Not provided
| >=65 years |
|
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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