Atrial FibrillationPINNACLE FLXNCT02702271
Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
A study testing WATCHMAN FLX in people with Atrial Fibrillation, run by Boston Scientific Corporation at 29 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- WATCHMAN FLX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 29 sitesUnited States
- Study dates
- 7 May 2018to 12 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.).
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Emory University
Atlanta, Georgia, 30308
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Grandview Medical Center
Birmingham, Alabama, 35243
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
Nair Research, LLC
Jonesboro, Arkansas, 72401
St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Green
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Catholic Medical Center
Manchester, New Hampshire, 03102
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York University Medical Center
New York, New York, 10016
Mt. Sinai School of Medicine
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85006
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85016
Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97227
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
Mayo Clinic
Rochester, Minnesota, 55902
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, 55102
Sharpe Chula Vista Medical Center
San Diego, California, 92121
St. John's Hospital / Pacific Heart
Santa Monica, California, 90404
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Cardiology Associates of N. Mississippi
Tupelo, Mississippi, 38801
PeaceHealth Southwest Medical
Vancouver, Washington, 98664
Washington Hospital Center
Washington D.C., District of Columbia, 20010
York Hospital
York, Pennsylvania, 17403
About this study
Official title: Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
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.
- Conditions
- Atrial Fibrillation
- Being tested
- WATCHMAN FLX
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN FLXDevice
Left atrial appendage closure with WATCHMAN FLX
| Study group | Role | What they receive |
|---|---|---|
| WATCHMAN FLX - M | Experimental | WATCHMAN FLX Main Cohort Receives: Device: WATCHMAN FLX |
| WATCHMAN FLX - R | Experimental | WATCHMAN FLX Roll-In Cohort Receives: Device: WATCHMAN FLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Safety Event
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.
Measured: events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later
Number of Participants With Effective LAA Closure
The rate of effective LAA closure, defined as any peri-device flow with jet size ≤ 5mm per core laboratory-assessed TEE at 12 months.
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start7 May 2018
- Primary completion28 Jan 2020
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shephal Doshi, MD, Principal investigator, St. John's Health CenterSaibal Kar, MD, Principal investigator, Los Robles Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702271
- Sponsor's protocol ID
- 91081206
- Acronym
- PINNACLE FLX
- Status last verified
- May 2022
- First submitted
- 3 Mar 2016
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kar S, Doshi SK, Sadhu A, Horton R, Osorio J, Ellis C, Stone J Jr, Shah M, Dukkipati SR, Adler S, Nair DG, Kim J, Wazni O, Price MJ, Asch FM, Holmes DR Jr, Shipley RD, Gordon NT, Allocco DJ, Reddy VY; PINNACLE FLX Investigators. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021 May 4;143(18):1754-1762. doi: 10.1161/CIRCULATIONAHA.120.050117. Epub 2021 Apr 6.
PubMed 33820423
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
- ClinicalTrials.gov ID
- NCT02702271
- Acronym / sponsor ID
- PINNACLE FLX / 91081206
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 7 May 2018 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 14 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 400 main cohort subjects and 58 roll-in subjects were enrolled at 29 investigational centers in the United States.
| Arm | Type | Receives |
|---|---|---|
| WATCHMAN FLX - M | Experimental | Device: WATCHMAN FLXWATCHMAN FLX Main Cohort |
| WATCHMAN FLX - R | Experimental | Device: WATCHMAN FLXWATCHMAN FLX Roll-In Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WATCHMAN FLXLeft atrial appendage closure with WATCHMAN FLX | Device | WATCHMAN FLX - M, WATCHMAN FLX - R |
Primary outcome
Number of Participants With a Safety Event
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33820423Kar S, Doshi SK, Sadhu A, Horton R, Osorio J, Ellis C, Stone J Jr, Shah M, Dukkipati SR, Adler S, Nair DG, Kim J, Wazni O, Price MJ, Asch FM, Holmes DR Jr, Shipley RD, Gordon NT, Allocco DJ, Reddy VY; PINNACLE FLX Investigators. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021 May 4;143(18):1754-1762. doi: 10.1161/CIRCULATIONAHA.120.050117. Epub 2021 Apr 6.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shephal Doshi, MD principal investigator
St. John's Health Center
Saibal Kar, MD principal investigator
Los Robles Regional Medical Center
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WATCHMAN FLX in people with Atrial Fibrillation, run by Boston Scientific Corporation at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Safety Event (time frame: events occurring between the time of implant and 7 days post procedure or by discharge, up to 30 days, whichever is later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702271, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.