Trial Outcomes & Findings for WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement (NCT NCT03173534)
NCT ID: NCT03173534
Last Updated: 2024-05-22
Results Overview
First occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
350 participants
Primary outcome timeframe
Through 2 year post-randomization
Results posted on
2024-05-22
Participant Flow
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.
Participant milestones
| Measure |
TAVR + Medical Therapy
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
172
|
177
|
|
Overall Study
COMPLETED
|
172
|
177
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
WATCH-TAVR, WATCHMAN for Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
Total
n=349 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
172 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Age, Continuous
|
81.5 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
80.8 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
81.1 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
340 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
172 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 2 year post-randomizationFirst occurrence of all-cause mortality, stroke (ischemic or hemorrhagic), or bleeding (life-threatening and major) events through 2 years post-randomization.
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
Composite of All-cause Mortality, Stroke and Bleeding
|
60 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Through 2 year post-randomizationAll deaths through 2 year
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
All-cause Mortality
|
39 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: Through 2 year post-randomizationFirst occurrence of any ischemic or hemorrhagic stroke through 2 year
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
Stroke
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Through 2 year post-randomizationFirst occurrence of any life-threatening or major bleeding through 2 year
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
Bleeding
|
30 Participants
|
35 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 2 year post-randomizationCardiovascular related mortality through 2 year
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
Cardiovascular Mortality
|
22 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 2 year post-randomizationIncidence of arterial or venous embolism
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
Thrombus or Embolism
|
3 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 2 year post-randomizationIncidence of re-hospitalizations related to the WATCHMAN procedure or WATCHMAN device
Outcome measures
| Measure |
TAVR + Medical Therapy
n=172 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 Participants
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
|
|---|---|---|
|
Re-hospitalization
|
22 Participants
|
18 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 2 year post-randomizationPopulation: Patient's with non missing KCCQ data
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.
Outcome measures
| Measure |
TAVR + Medical Therapy
n=169 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=176 Participants
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
|
|---|---|---|
|
Quality of Life Score: KCCQ-12
KCCQ Questionnaire Score Visit 1-Baseline
|
39.77 score on a scale
Standard Deviation 15.55
|
40.8 score on a scale
Standard Deviation 15.21
|
|
Quality of Life Score: KCCQ-12
KCCQ Questionnaire Score Visit 2- 45 Days
|
55.2 score on a scale
Standard Deviation 17.77
|
55.1 score on a scale
Standard Deviation 17.94
|
|
Quality of Life Score: KCCQ-12
KCCQ Questionnaire Score (Visit 3- 6 Months)
|
56.6 score on a scale
Standard Deviation 17.97
|
57.61 score on a scale
Standard Deviation 15.18
|
|
Quality of Life Score: KCCQ-12
KCCQ Questionnaire Score (Visit 4-12 Months)
|
56.3 score on a scale
Standard Deviation 18.42
|
57.4 score on a scale
Standard Deviation 15.67
|
|
Quality of Life Score: KCCQ-12
KCCQ Questionnaire Score (Visit 5- 24 months)
|
57.1 score on a scale
Standard Deviation 18.99
|
57.0 score on a scale
Standard Deviation 16.51
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Mean cost during hospitalization up to 40 days.Population: Sites willing to provide cost data.
Procedural costs related to the initial TAVR and WATCHMAN procedures
Outcome measures
| Measure |
TAVR + Medical Therapy
n=25 Participants
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=21 Participants
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
|
|---|---|---|
|
Procedural Costs
|
195309.64 dollars
Standard Deviation 206704.690
|
216020.41 dollars
Standard Deviation 91603.542
|
Adverse Events
TAVR + Medical Therapy
Serious events: 90 serious events
Other events: 131 other events
Deaths: 39 deaths
TAVR + WATCHMAN
Serious events: 87 serious events
Other events: 127 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
TAVR + Medical Therapy
n=172 participants at risk
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Cardiac - Other
|
15.1%
26/172 • Events collected within two years following randomization.
|
16.4%
29/177 • Events collected within two years following randomization.
|
|
Blood and lymphatic system disorders
Bleeding - Event Associated with bleeding
|
15.1%
26/172 • Events collected within two years following randomization.
|
17.5%
31/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Heart Failure
|
4.1%
7/172 • Events collected within two years following randomization.
|
10.2%
18/177 • Events collected within two years following randomization.
|
|
Renal and urinary disorders
Renal - Other (not bleeding)
|
3.5%
6/172 • Events collected within two years following randomization.
|
4.5%
8/177 • Events collected within two years following randomization.
|
|
Infections and infestations
Infection - Other (except endocarditis and device infection)
|
4.1%
7/172 • Events collected within two years following randomization.
|
5.1%
9/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Sudden Cardiac Death/Cardiac Arrest
|
4.7%
8/172 • Events collected within two years following randomization.
|
2.8%
5/177 • Events collected within two years following randomization.
|
|
General disorders
Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
|
2.3%
4/172 • Events collected within two years following randomization.
|
5.1%
9/177 • Events collected within two years following randomization.
|
|
Blood and lymphatic system disorders
Anemia
|
3.5%
6/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
General disorders
Cancer/Malignancy
|
2.3%
4/172 • Events collected within two years following randomization.
|
3.4%
6/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Respiratory Failure
|
2.3%
4/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Ischemic Stroke
|
1.7%
3/172 • Events collected within two years following randomization.
|
2.8%
5/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pleural Effusion
|
1.7%
3/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Other
|
2.3%
4/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Stroke Type Unknown
|
2.9%
5/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Trauma
|
0.58%
1/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Renal and urinary disorders
Renal - AKI (requiring dialysis)
|
2.3%
4/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Pericardial Effusion (not hemorrhagic)
|
1.7%
3/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Infections and infestations
COVID-19 Infection
|
1.2%
2/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
General disorders
Rehospitalization related to TAVR device or procedure
|
1.7%
3/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Infections and infestations
Infection - UTI
|
1.2%
2/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Other systemic
|
0.58%
1/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Gastrointestinal disorders
GI- Other (not bleeding)
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Endocarditis
|
1.2%
2/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
General disorders
COD Unknown
|
2.3%
4/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Embolism
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - TIA
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Myocardial Infarction
|
1.7%
3/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - AV Regurgitation/Leak
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - WATCHMAN Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Thrombus- Atrial (not arterial)
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
General disorders
Septic Shock
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Endocrine disorders
Endocrine Disorders
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Angina/Chest Pain/CAD
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pneumonia
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - COPD
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Subdural Hematoma
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Vascular AV Fistula (intervention required)
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neruo- Mental Status Changes/Confusion (not stroke or TIA)
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Heart Valve Damage
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Venous (including DVT)
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - TAVR Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Other NON Cardiac Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Hypokalemia
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
General disorders
Supra-therapeutic INR
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Hepatobiliary (not bleeding)
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Rehospitalization related to WATCHMAN procedure or device (not listed above)
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Device Embolization - Catheter Retrieval
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis- Venous (including DVT)
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Rehospitalization related to WATCHMAN procedure or device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
Other adverse events
| Measure |
TAVR + Medical Therapy
n=172 participants at risk
n=175 will undergo Transcatheter Aortic Valve Replacement (TAVR) alone with medical management for atrial fibrillation
TAVR: Transcatheter Aortic Valve Replacement
|
TAVR + WATCHMAN
n=177 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
31.4%
54/172 • Events collected within two years following randomization.
|
32.2%
57/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Other
|
23.3%
40/172 • Events collected within two years following randomization.
|
32.2%
57/177 • Events collected within two years following randomization.
|
|
Renal and urinary disorders
Rental
|
3.5%
6/172 • Events collected within two years following randomization.
|
4.5%
8/177 • Events collected within two years following randomization.
|
|
General disorders
Trauma
|
5.8%
10/172 • Events collected within two years following randomization.
|
5.6%
10/177 • Events collected within two years following randomization.
|
|
Infections and infestations
Infection
|
6.4%
11/172 • Events collected within two years following randomization.
|
7.9%
14/177 • Events collected within two years following randomization.
|
|
Blood and lymphatic system disorders
Anemia
|
7.0%
12/172 • Events collected within two years following randomization.
|
4.0%
7/177 • Events collected within two years following randomization.
|
|
General disorders
Any AE with symptoms that could possibly be contributed to WATCHMAN or TAVR device/procedure
|
4.7%
8/172 • Events collected within two years following randomization.
|
6.8%
12/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic
|
4.7%
8/172 • Events collected within two years following randomization.
|
5.6%
10/177 • Events collected within two years following randomization.
|
|
Renal and urinary disorders
Infection - UTI
|
3.5%
6/172 • Events collected within two years following randomization.
|
2.8%
5/177 • Events collected within two years following randomization.
|
|
General disorders
Cancer/Malignancy
|
2.9%
5/172 • Events collected within two years following randomization.
|
5.1%
9/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Sudden Cardiac Death/Cardiac Arrest
|
5.2%
9/172 • Events collected within two years following randomization.
|
2.8%
5/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Ischemic Stroke
|
3.5%
6/172 • Events collected within two years following randomization.
|
4.5%
8/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - TIA
|
4.1%
7/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Respiratory Failure
|
2.9%
5/172 • Events collected within two years following randomization.
|
2.8%
5/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
3.5%
6/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Angina/Chest Pain/CAD
|
2.9%
5/172 • Events collected within two years following randomization.
|
2.8%
5/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pleural Effusion
|
2.3%
4/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Infections and infestations
COVID-19 Infection
|
2.3%
4/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Pneumonia
|
3.5%
6/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
General disorders
COD Unknown
|
3.5%
6/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Pericardial Effusion (not hemorrhagic)
|
2.3%
4/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Stroke Type Unknown
|
3.5%
6/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Mental Status Changes/Confusion
|
1.7%
3/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Venous (including DVT)
|
1.7%
3/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Renal and urinary disorders
Renal- AKI (requiring dialysis)
|
2.3%
4/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
General disorders
Rehospitalization related to TAVR device or procedure (not listed)
|
2.3%
4/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombus - Atrial (not arterial)
|
0.00%
0/172 • Events collected within two years following randomization.
|
3.4%
6/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Endocarditis
|
1.2%
2/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Gastrointestinal disorders
GI- Other (not bleeding)
|
0.00%
0/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Myocardial Infarction
|
1.7%
3/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Other Systemic (other than stroke)
|
0.58%
1/172 • Events collected within two years following randomization.
|
1.7%
3/177 • Events collected within two years following randomization.
|
|
Blood and lymphatic system disorders
Hypokalemia
|
1.2%
2/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Endocrine disorders
Endocrine Disorders
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Embolism
|
0.00%
0/172 • Events collected within two years following randomization.
|
2.3%
4/177 • Events collected within two years following randomization.
|
|
Nervous system disorders
Neurologic - Subdural Hematoma
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - AV Regurg/Leak
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Vascular Pseudoaneurysm
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - WATCHMAN Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Infections and infestations
Septic Shock
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Atrial Septal Defect (latrogenic)
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Device Embolization - Catheter Retrieval
|
0.00%
0/172 • Events collected within two years following randomization.
|
1.1%
2/177 • Events collected within two years following randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - COPD
|
1.2%
2/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Vascular AV Fistual
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Benign & Malignant
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
General disorders
Leukocytosis
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Cardiac disorders
Cardiac - Heart Valve Damage
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Infections and infestations
Inflammatory/Immunologic
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - TAVR Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Vascular AV Fistula
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Other NON Cardiac Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Vascular disorders
Thrombosis - Other Cardiac Device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Supra-therapeutic INR
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Hepatobiliary disorders
Hepatobiliary (not bleeding)
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
General disorders
Rehospitalization related to WATCHMAN procedure or device
|
0.00%
0/172 • Events collected within two years following randomization.
|
0.56%
1/177 • Events collected within two years following randomization.
|
|
Gastrointestinal disorders
Pancreatic
|
0.58%
1/172 • Events collected within two years following randomization.
|
0.00%
0/177 • Events collected within two years following randomization.
|
Additional Information
Samir Kapadia, MD Chairman Cardiovascular Medicine
Cleveland Clinic
Phone: 216 444-6735
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place