Trial · NCT03795298
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
NCT03795298, Not applicable, Completed, Boston Scientific Corporation; results first posted 2025-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation. Trials, record NCT03795298. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03795298
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
- NCT number
- NCT03795298
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,600 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Atrial Fibrillation
- Interventions
- WATCHMAN FLX Implant, Market-approved OAC
- First posted
- 2019-01-07
- Last updated
- 2025-09-18
- Results first posted
- 2025-09-18
- Limitations and caveats
The study had several exclusion criteria and results may not be applicable to the excluded populations. Pulsed field ablation was not available at the time of the trial. Although type of ablation technology used is unlikely to affect antithrombotic strategy, any unique considerations for this ablation method could not be investigated in the present study.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism | From randomization to 1095 days post randomization | Occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism events adjudicated by an Independent Clinical Event Committee |
| Primary | Primary Safety Endpoint: Non-procedural Bleeding | Non-procedural events are those occurring after 3 days, calculated from implant or attempted implant date for Device patients and from date of randomization for Control patients | Occurrence of non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding) events adjudicated by an Independent Clinical Event Committee |
| Secondary | ISTH Major Bleeding | From randomization to 1095 days post randomization | Occurence of ISTH major bleeding (including procedural bleeding) events adjudicated by an Independent Clinical Event Committee |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism | From randomization to 1095 days post randomization | The primary analysis for the primary effectiveness endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Primary Safety Endpoint: Non-procedural Bleeding | Non-procedural events are those occurring after 3 days, calculated from implant or attempted implant date for Device patients and from date of randomization for Control patients | The primary analysis for the primary safety endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ISTH Major Bleeding | From randomization to 1095 days post randomization | The primary analysis for the secondary endpoint was performed on an intent-to-treat basis, with all randomized subjects analyzed as part of their randomized group regardless of the actual treatment received | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism | Oral Anticoagulant (Control) | 44 | Participants | ||
| Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism | WATCHMAN FLX DEVICE | 41 | Participants | ||
| Primary Safety Endpoint: Non-procedural Bleeding | Oral Anticoagulant (Control) | 137 | Participants | ||
| Primary Safety Endpoint: Non-procedural Bleeding | WATCHMAN FLX DEVICE | 65 | Participants | ||
| ISTH Major Bleeding | Oral Anticoagulant (Control) | 38 | Participants | ||
| ISTH Major Bleeding | WATCHMAN FLX DEVICE | 30 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Anticoagulant (Control) | 797 | |
| Overall Study | STARTED | WATCHMAN FLX DEVICE | 803 | |
| Overall Study | COMPLETED | Oral Anticoagulant (Control) | 679 | |
| Overall Study | COMPLETED | WATCHMAN FLX DEVICE | 714 | |
| Overall Study | NOT COMPLETED | Oral Anticoagulant (Control) | 118 | |
| Overall Study | NOT COMPLETED | WATCHMAN FLX DEVICE | 89 |
Source ClinicalTrials.gov
Adverse events1,466
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Oral Anticoagulant (Control) | 4 | 797 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | WATCHMAN FLX DEVICE | 1 | 803 | 1 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | Oral Anticoagulant (Control) | 1 | 797 | 1 |
| other | Haemorrhagic anaemia | Blood and lymphatic system disorders | WATCHMAN FLX DEVICE | 1 | 803 | 1 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | Oral Anticoagulant (Control) | 1 | 797 | 1 |
| other | Haemorrhagic disorder | Blood and lymphatic system disorders | WATCHMAN FLX DEVICE | 0 | 803 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Oral Anticoagulant (Control) | 2 | 797 | 2 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | WATCHMAN FLX DEVICE | 0 | 803 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Oral Anticoagulant (Control) | 0 | 797 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | WATCHMAN FLX DEVICE | 2 | 803 | 2 |
1 to 10 of 1,466Source ClinicalTrials.gov
See all 1,466 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Anticoagulant (Control) | 35 | 797 |
| Total, all-cause mortality | WATCHMAN FLX DEVICE | 31 | 803 |
| Total, other adverse events | Oral Anticoagulant (Control) | 248 | 797 |
| Total, other adverse events | WATCHMAN FLX DEVICE | 254 | 803 |
| Total, serious adverse events | Oral Anticoagulant (Control) | 797 | 797 |
| Total, serious adverse events | WATCHMAN FLX DEVICE | 803 | 803 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: ISTH Major Bleeding | Trial comparisons |
| Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: Primary Safety Endpoint: Non-procedural Bleeding | Trial comparisons |
| Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: deaths from any cause | Trial comparisons |
| Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: Primary Effectiveness Endpoint: Stroke, All Cause Death, and Systemic Embolism | Trial comparisons |
| Oral Anticoagulant (Control) vs WATCHMAN FLX DEVICE: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03795298
GET https://conductscience.org/api/trials/v1/NCT03795298/events?page=2