PINNACLE FLX: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02702271
Collaborator
(none)
458
29
2
34.2
15.8
0.5
Study Details
Study Description
Brief Summary
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
458 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
A total of 400 main cohort subjects and 58 roll-in subjects were enrolled at 29 investigational centers in the United States.A total of 400 main cohort subjects and 58 roll-in subjects were enrolled at 29 investigational centers in the United States.
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
Actual Study Start Date
:
May 7, 2018
Actual Primary Completion Date
:
Jan 28, 2020
Actual Study Completion Date
:
Mar 12, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: WATCHMAN FLX - M WATCHMAN FLX Main Cohort |
Device: WATCHMAN FLX
Left atrial appendage closure with WATCHMAN FLX
|
| Experimental: WATCHMAN FLX - R WATCHMAN FLX Roll-In Cohort |
Device: WATCHMAN FLX
Left atrial appendage closure with WATCHMAN FLX
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Safety Event [events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later]
The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint.
- Number of Participants With Effective LAA Closure [12-months]
The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
The subject is 18 years of age or older.
-
The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
-
The subject is eligible for the defined protocol pharmacologic regimen of anticoagulation and antiplatelet therapy following WATCHMAN FLX Device implant.
-
The subject is eligible to come off of anticoagulation therapy if the LAA is sealed (i.e., the subject has no other conditions that would require long-term anticoagulation therapy suggested by current standard medical practice).
-
The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
-
The subject is able to understand and willing to provide written informed consent to participate in the trial.
-
The subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
-
Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility, regardless of type of co-enrollment being proposed.
-
The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoaguable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue anticoagulation due to other medical conditions requiring chronic anticoagulation therapy).
-
The subject is contraindicated for short-term anticoagulant therapy with DOAC post-implant.
-
The subject is contraindicated to aspirin and/or clopidogrel.
-
The subject is indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to the WATCHMAN FLX Device implant.
-
The subject had or is planning to have any cardiac or non-cardiac invasive or surgical procedure within 30 days prior to or 60 days after the WATCHMAN FLX Device implant (including, but not limited to: cardioversion, coronary angiogram with or without percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, endoscopy, etc.).
-
The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 90 days prior to enrollment.
-
The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 90 days prior to enrollment.
-
The subject has a history of atrial septal repair or has an ASD/PFO device.
-
The subject has an implanted mechanical valve prosthesis in any position.
-
The subject currently has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment.
-
The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
-
The subject has a documented life expectancy of less than 2 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Grandview Medical Center | Birmingham | Alabama | United States | 35243 |
| 2 | Phoenix Cardiovascular Research Group | Phoenix | Arizona | United States | 85006 |
| 3 | St. Joseph's Hospital & Medical Center | Phoenix | Arizona | United States | 85016 |
| 4 | Nair Research, LLC | Jonesboro | Arkansas | United States | 72401 |
| 5 | Scripps Green | La Jolla | California | United States | 92037 |
| 6 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 7 | Sharpe Chula Vista Medical Center | San Diego | California | United States | 92121 |
| 8 | St. John's Hospital / Pacific Heart | Santa Monica | California | United States | 90404 |
| 9 | Washington Hospital Center | Washington | District of Columbia | United States | 20010 |
| 10 | Tallahassee Memorial Hospital | Tallahassee | Florida | United States | 32308 |
| 11 | Emory University | Atlanta | Georgia | United States | 30308 |
| 12 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 13 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 14 | Mayo Clinic | Rochester | Minnesota | United States | 55902 |
| 15 | HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | United States | 55102 |
| 16 | Cardiology Associates of N. Mississippi | Tupelo | Mississippi | United States | 38801 |
| 17 | St. Luke's Hospital | Kansas City | Missouri | United States | 64111 |
| 18 | Catholic Medical Center | Manchester | New Hampshire | United States | 03102 |
| 19 | Cardiovascular Associates of the Delaware Valley | Sewell | New Jersey | United States | 08080 |
| 20 | New York University Medical Center | New York | New York | United States | 10016 |
| 21 | Mt. Sinai School of Medicine | New York | New York | United States | 10029 |
| 22 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 23 | Legacy Emanuel Hospital & Health Center | Portland | Oregon | United States | 97227 |
| 24 | York Hospital | York | Pennsylvania | United States | 17403 |
| 25 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 26 | Texas Cardiac Arrhythmia | Austin | Texas | United States | 78705 |
| 27 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 28 | Virginia Commonwealth University Health System | Richmond | Virginia | United States | 23219 |
| 29 | PeaceHealth Southwest Medical | Vancouver | Washington | United States | 98664 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Shephal Doshi, MD, St. John's Health Center
- Principal Investigator: Saibal Kar, MD, Los Robles Regional Medical Center
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02702271
Other Study ID Numbers:
- 91081206
First Posted:
Mar 8, 2016
Last Update Posted:
Jun 14, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | WATCHMAN FLX - M | WATCHMAN FLX - R |
|---|---|---|
| Arm/Group Description | Main Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | Roll-In Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX |
| Period Title: Overall Study | ||
| STARTED | 400 | 58 |
| COMPLETED | 337 | 49 |
| NOT COMPLETED | 63 | 9 |
Baseline Characteristics
| Arm/Group Title | WATCHMAN FLX - M | WATCHMAN FLX - R | Total |
|---|---|---|---|
| Arm/Group Description | Main Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | Roll-In Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | Total of all reporting groups |
| Overall Participants | 400 | 58 | 458 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
55
13.8%
|
7
12.1%
|
62
13.5%
|
| >=65 years |
345
86.3%
|
51
87.9%
|
396
86.5%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
73.8
(8.6)
|
75.2
(8.5)
|
74.0
(8.6)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
142
35.5%
|
24
41.4%
|
166
36.2%
|
| Male |
258
64.5%
|
34
58.6%
|
292
63.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
10
2.5%
|
0
0%
|
10
2.2%
|
| Not Hispanic or Latino |
390
97.5%
|
58
100%
|
448
97.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
1
0.3%
|
0
0%
|
1
0.2%
|
| Asian |
2
0.5%
|
0
0%
|
2
0.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
18
4.5%
|
2
3.4%
|
20
4.4%
|
| White |
358
89.5%
|
51
87.9%
|
409
89.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
21
5.3%
|
5
8.6%
|
26
5.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
400
100%
|
58
100%
|
458
100%
|
Outcome Measures
| Title | Number of Participants With a Safety Event |
|---|---|
| Description | The occurrence of one of the following events : all-cause death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair. Percutaneous catheter drainage of pericardial effusions, snaring of an embolized device, thrombin injection to treat femoral pseudoaneurysm and nonsurgical treatments of access site complications are captured as adverse events (AEs), and are excluded from this endpoint. |
| Time Frame | events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | WATCHMAN FLX - M | WATCHMAN FLX - R |
|---|---|---|
| Arm/Group Description | Main Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | Roll-In Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX |
| Measure Participants | 400 | 58 |
| Count of Participants [Participants] |
2
0.5%
|
0
0%
|
| Title | Number of Participants With Effective LAA Closure |
|---|---|
| Description | The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months. |
| Time Frame | 12-months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Primary Effectiveness Endpoint is the rate of effective LAA closure at 12 months (defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE). The overall number of participants analyzed (342 in main and 52 in roll-in cohort) are the number of participants who had evaluable 12 month core lab f/u data from the total number of participants enrolled. |
| Arm/Group Title | WATCHMAN FLX - M | WATCHMAN FLX - R |
|---|---|---|
| Arm/Group Description | Main Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | Roll-In Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX |
| Measure Participants | 342 | 52 |
| Count of Participants [Participants] |
342
85.5%
|
52
89.7%
|
Adverse Events
| Time Frame | Adverse events that occur through 24 months post procedure. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | WATCHMAN FLX - M | WATCHMAN FLX - R | ||
| Arm/Group Description | Main Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | Roll-In Cohort WATCHMAN FLX: Left atrial appendage closure with WATCHMAN FLX | ||
All Cause Mortality |
||||
| WATCHMAN FLX - M | WATCHMAN FLX - R | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/400 (9%) | 7/58 (12.1%) | ||
Serious Adverse Events |
||||
| WATCHMAN FLX - M | WATCHMAN FLX - R | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 157/400 (39.3%) | 25/58 (43.1%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 11/400 (2.8%) | 13 | 1/58 (1.7%) | 1 |
| Anaemia macrocytic | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Haemorrhagic anaemia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Iron deficiency anaemia | 3/400 (0.8%) | 4 | 0/58 (0%) | 0 |
| Microcytic anaemia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Thrombocytopenia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cardiac disorders | ||||
| Acute myocardial infarction | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Angina pectoris | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Angina unstable | 1/400 (0.3%) | 2 | 0/58 (0%) | 0 |
| Aortic valve stenosis | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Atrial fibrillation | 36/400 (9%) | 38 | 3/58 (5.2%) | 4 |
| Atrial flutter | 7/400 (1.8%) | 8 | 0/58 (0%) | 0 |
| Atrial tachycardia | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Atrioventricular block complete | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Bradycardia | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Cardiac arrest | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cardiac failure | 5/400 (1.3%) | 6 | 1/58 (1.7%) | 1 |
| Cardiac failure acute | 7/400 (1.8%) | 7 | 1/58 (1.7%) | 1 |
| Cardiac failure congestive | 15/400 (3.8%) | 22 | 6/58 (10.3%) | 6 |
| Cardio-respiratory arrest | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Cardiogenic shock | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Cardiomyopathy | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Coronary artery disease | 6/400 (1.5%) | 6 | 1/58 (1.7%) | 1 |
| Coronary artery occlusion | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hypertensive heart disease | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Intracardiac thrombus | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Mitral valve incompetence | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Myocardial infarction | 2/400 (0.5%) | 2 | 2/58 (3.4%) | 2 |
| Pericardial effusion | 8/400 (2%) | 9 | 0/58 (0%) | 0 |
| Pericarditis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pericarditis constrictive | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Sinus node dysfunction | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Tricuspid valve incompetence | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Ventricular fibrillation | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Ventricular tachycardia | 2/400 (0.5%) | 2 | 1/58 (1.7%) | 1 |
| Ear and labyrinth disorders | ||||
| Vertigo | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Abdominal wall haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Colitis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Faeces discoloured | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Gastritis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Gastrointestinal haemorrhage | 15/400 (3.8%) | 16 | 8/58 (13.8%) | 9 |
| Haematochezia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Lower gastrointestinal haemorrhage | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Melaena | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Odynophagia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Oesophageal perforation | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pancreatitis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pancreatolithiasis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Rectal haemorrhage | 3/400 (0.8%) | 3 | 1/58 (1.7%) | 1 |
| Rectal prolapse | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Small intestinal obstruction | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Umbilical hernia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Upper gastrointestinal haemorrhage | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| General disorders | ||||
| Asthenia | 3/400 (0.8%) | 3 | 1/58 (1.7%) | 1 |
| Catheter site haematoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Chest discomfort | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Chest pain | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Death | 5/400 (1.3%) | 5 | 0/58 (0%) | 0 |
| Device related thrombosis | 6/400 (1.5%) | 6 | 2/58 (3.4%) | 2 |
| Generalised oedema | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hernia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Incarcerated hernia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Multimorbidity | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Multiple organ dysfunction syndrome | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Non-cardiac chest pain | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pyrexia | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Systemic inflammatory response syndrome | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Ulcer haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholangitis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cholecystitis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hepatic failure | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 2 |
| Infections and infestations | ||||
| Appendicitis | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Arthritis infective | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Bacterial sepsis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Bronchitis | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Cellulitis | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Corona virus infection | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Diverticulitis | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Diverticulitis intestinal haemorrhagic | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Gastroenteritis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Gastroenteritis salmonella | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Influenza | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Kidney infection | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Neutropenic sepsis | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Nocardiosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Oesophageal candidiasis | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Osteomyelitis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pancreatic abscess | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Perinephric abscess | 1/400 (0.3%) | 3 | 0/58 (0%) | 0 |
| Pneumonia | 18/400 (4.5%) | 19 | 4/58 (6.9%) | 5 |
| Respiratory tract infection | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Sepsis | 10/400 (2.5%) | 11 | 1/58 (1.7%) | 1 |
| Septic shock | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Staphylococcal sepsis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Subacute endocarditis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Urinary tract infection | 5/400 (1.3%) | 5 | 2/58 (3.4%) | 2 |
| Wound infection | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Anaemia postoperative | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Arteriovenous fistula thrombosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Facial bones fracture | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Fall | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Femur fracture | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Hip fracture | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Incision site haematoma | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Injury | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Joint dislocation | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Post procedural haematoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Post procedural haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pubis fracture | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Spinal compression fracture | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Spinal fracture | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Subarachnoid haemorrhage | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Subdural haematoma | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Vascular pseudoaneurysm | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Wound dehiscence | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Wound evisceration | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Investigations | ||||
| Influenza A virus test positive | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Influenza B virus test positive | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Dehydration | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Fluid overload | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hyperkalaemia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hypokalaemia | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Hyponatraemia | 2/400 (0.5%) | 3 | 0/58 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthropathy | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Back pain | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Cervical spinal stenosis | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Lumbar spinal stenosis | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Osteoarthritis | 8/400 (2%) | 9 | 1/58 (1.7%) | 1 |
| Spinal column stenosis | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Acute myeloid leukaemia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Bladder cancer | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Breast cancer | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Chronic myeloid leukaemia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hepatocellular carcinoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Neoplasm malignant | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Non-Hodgkin's lymphoma metastatic | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pancreatic carcinoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Plasma cell myeloma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Prostate cancer | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Nervous system disorders | ||||
| Carotid artery stenosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cerebral infarction | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cerebrovascular accident | 4/400 (1%) | 5 | 1/58 (1.7%) | 1 |
| Dizziness | 1/400 (0.3%) | 3 | 0/58 (0%) | 0 |
| Embolic stroke | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Encephalopathy | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Hydrocephalus | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hypertensive encephalopathy | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Ischaemic stroke | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Paraesthesia | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Presyncope | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Seizure | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Syncope | 5/400 (1.3%) | 5 | 4/58 (6.9%) | 4 |
| Transient ischaemic attack | 3/400 (0.8%) | 3 | 1/58 (1.7%) | 2 |
| Product Issues | ||||
| Device leakage | 10/400 (2.5%) | 12 | 0/58 (0%) | 0 |
| Lead dislodgement | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Psychiatric disorders | ||||
| Delirium | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Depression | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Mental status changes | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 8/400 (2%) | 8 | 1/58 (1.7%) | 1 |
| Cystitis haemorrhagic | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| End stage renal disease | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Haematuria | 4/400 (1%) | 6 | 0/58 (0%) | 0 |
| Renal failure | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Renal pain | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Urinary retention | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Reproductive system and breast disorders | ||||
| Cervical dysplasia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Vaginal haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Vaginal prolapse | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute pulmonary oedema | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Acute respiratory failure | 7/400 (1.8%) | 7 | 0/58 (0%) | 0 |
| Asthma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Bronchiectasis | 0/400 (0%) | 0 | 1/58 (1.7%) | 3 |
| Chronic obstructive pulmonary disease | 3/400 (0.8%) | 3 | 1/58 (1.7%) | 1 |
| Dysphonia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Dyspnoea | 3/400 (0.8%) | 3 | 1/58 (1.7%) | 1 |
| Epistaxis | 4/400 (1%) | 4 | 1/58 (1.7%) | 1 |
| Haemoptysis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Haemothorax | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Lung infiltration | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Pleural effusion | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Pulmonary embolism | 4/400 (1%) | 4 | 2/58 (3.4%) | 2 |
| Pulmonary fibrosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Pulmonary oedema | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Respiratory failure | 5/400 (1.3%) | 6 | 1/58 (1.7%) | 1 |
| Rheumatoid lung | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Skin ulcer | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Vascular disorders | ||||
| Accelerated hypertension | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Deep vein thrombosis | 4/400 (1%) | 4 | 2/58 (3.4%) | 2 |
| Haematoma | 2/400 (0.5%) | 2 | 1/58 (1.7%) | 1 |
| Hypotension | 5/400 (1.3%) | 5 | 0/58 (0%) | 0 |
| Orthostatic hypotension | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Peripheral arterial occlusive disease | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Peripheral artery stenosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Peripheral artery thrombosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Vena cava thrombosis | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| WATCHMAN FLX - M | WATCHMAN FLX - R | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 96/400 (24%) | 15/58 (25.9%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 5/400 (1.3%) | 5 | 2/58 (3.4%) | 3 |
| Thrombocytopenia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cardiac disorders | ||||
| Atrial fibrillation | 2/400 (0.5%) | 2 | 1/58 (1.7%) | 1 |
| Atrial flutter | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Atrial septal defect acquired | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Bradycardia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Cardiac steatosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Chordae tendinae rupture | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Intracardiac thrombus | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Pericardial effusion | 10/400 (2.5%) | 10 | 0/58 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||
| Atrial septal defect | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Congenital oesophageal anomaly | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Eye disorders | ||||
| Conjunctival haemorrhage | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Eye haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Ocular hyperaemia | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Retinal haemorrhage | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Abdominal pain upper | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Abdominal wall haematoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Diarrhoea | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Dysphagia | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Gastric ulcer haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Gastrointestinal haemorrhage | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Gastrooesophageal reflux disease | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Haematemesis | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Haematochezia | 1/400 (0.3%) | 1 | 2/58 (3.4%) | 2 |
| Lower gastrointestinal haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Rectal haemorrhage | 2/400 (0.5%) | 2 | 3/58 (5.2%) | 3 |
| Tongue haematoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Vomiting | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| General disorders | ||||
| Cardiac complication associated with device | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Catheter site bruise | 0/400 (0%) | 0 | 2/58 (3.4%) | 2 |
| Catheter site haematoma | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Catheter site haemorrhage | 7/400 (1.8%) | 7 | 0/58 (0%) | 0 |
| Catheter site vesicles | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Chest discomfort | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Infections and infestations | ||||
| Urinary tract infection | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Arteriovenous fistula site haemorrhage | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Cardiac septal defect residual shunt | 4/400 (1%) | 4 | 1/58 (1.7%) | 1 |
| Contusion | 14/400 (3.5%) | 16 | 1/58 (1.7%) | 1 |
| Head injury | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Laceration | 3/400 (0.8%) | 3 | 0/58 (0%) | 0 |
| Post procedural haematuria | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Post procedural haemorrhage | 4/400 (1%) | 4 | 0/58 (0%) | 0 |
| Procedural haemorrhage | 2/400 (0.5%) | 2 | 0/58 (0%) | 0 |
| Subarachnoid haematoma | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Wrist fracture | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Hypovitaminosis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Nervous system disorders | ||||
| Cerebral haematoma | 0/400 (0%) | 0 | 1/58 (1.7%) | 1 |
| Cerebrovascular accident | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Headache | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Ischaemic stroke | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Transient ischaemic attack | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Product Issues | ||||
| Device leakage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Renal and urinary disorders | ||||
| Acute kidney injury | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Haematuria | 7/400 (1.8%) | 8 | 3/58 (5.2%) | 3 |
| Nephrolithiasis | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Urinary retention | 2/400 (0.5%) | 2 | 1/58 (1.7%) | 1 |
| Reproductive system and breast disorders | ||||
| Vaginal haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Dyspnoea exertional | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Epistaxis | 18/400 (4.5%) | 18 | 4/58 (6.9%) | 4 |
| Haemoptysis | 3/400 (0.8%) | 4 | 0/58 (0%) | 0 |
| Oropharyngeal pain | 1/400 (0.3%) | 1 | 1/58 (1.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Ecchymosis | 6/400 (1.5%) | 6 | 0/58 (0%) | 0 |
| Vascular disorders | ||||
| Haematoma | 5/400 (1.3%) | 6 | 1/58 (1.7%) | 1 |
| Haemorrhage | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hypertension | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
| Hypotension | 1/400 (0.3%) | 1 | 0/58 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | Boston Scientific |
| Phone | 1-800-CARDIAC |
| peter.maurer@bsci.com |
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02702271
Other Study ID Numbers:
- 91081206
First Posted:
Mar 8, 2016
Last Update Posted:
Jun 14, 2022
Last Verified:
May 1, 2022