Atrial FibrillationREFLXNCT03339193
Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
An observational study of Atrial Fibrillation and Stroke, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Left atrial appendage closure
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2016
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective left atrial appendage occlusion/closure in accordance with UK guidelines
Who may be able to join
- Subjects who are eligible for a WATCHMAN FLX device per physician discretion according to current international and local guidelines and currently approved indications
- Subjects who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre
- Subjects whose age is 18 years or above, or of legal age to give informed consent specific to national law.
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 patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- Subjects who are unable or not willing to complete the follow-up visits and examination at 6 weeks.
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
- Documented life expectancy of less than 12 months.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Cardiology, John Radcliffe Hospital
Oxford, OX3 9DU
About this study
This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy.
Read the detailed description
Principal study aim: To document the impact of the next generation of Watchman LAAC device on key aspects of the implant procedure
Study Rationale: As an interventional procedure it is important that progressive steps are made to make the procedure safer, simpler, faster and more cost-effective. This study will document the impact of introducing the next generation of LAAC device, the Watchman FLX, into a clinical service. It is anticipated that the increased versatility of the Watchman FLX will lead to fewer repositionings and redeployments, shortening procedure time and reducing the mean number of devices opened per case.
Patients to be enrolled: Consecutive patients implanted with the Watchman FLX. All patients will meet current United Kingdom guidelines for LAAC, i.e. have atrial fibrillation, a high risk of thromboembolic stroke (CHA2DS2VASc score >2) and contraindications to long-term oral anticoagulation.
Study design: This is a prospective single-centre observational case-controlled study to be conducted at the John Radcliffe Hospital, Oxford, United Kingdom
Outcomes: Data collected will include patient demographics, left atrial appendage (LAA) dimensions and anatomical description, total procedure duration, device implant time (from introduction of Access sheath to cable release), number of devices opened/ used, number of repositions and redeployments, final position, presence of residual leak, acute complications, peri- and post-procedure antiplatelet and anticoagulant use and 6 week transesophageal echo findings. There will be a particular focus on the need for repositioning and redeployment and how that is undertaken (e.g. advancement of device distally into the LAA).
Timelines: For 20 patients in each group, 7 months from first patient enrolled to final patient undergoing 6 week transesophageal echo (TEE) followup will be required.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Left atrial appendage closure
- Keywords
- atrial fibrillation, stroke, atrial appendage
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial appendage closureDevice
Percutaneous insertion of a Watchman FLX left atrial appendage closure device under general anesthesia with transesophageal echo guidance.
| Study group | Role | What they receive |
|---|---|---|
| Patients having LAAC | Patients who meet current clinical criteria for left atrial appendage closure (LAAC), ie have atrial fibrillation, a CHA2DS2-VASc score of 3 or more and a contraindication to long-term oral anticoagulation therapy and who have been approved by the OUH NHS Foundation Trust LAAC Multidisciplinary Team (MDT) as suitable for left atrial appendage occlusion in accordance with National Health Service (NHS) guidelines. Receives: Device: Left atrial appendage closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rates, (redeployments and devices used)
Implant characteristics. This is a descriptive study
Measured: Implant procedure
Procedural characteristics (including number of repositions),
Implant characteristics. This is a descriptive study
Measured: Implant procedure
Secondary outcomes (1)
Procedure complications
Implant characteristics. This is a descriptive study
Measured: Implant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Tim Betts, MD, Study director, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339193
- Sponsor's protocol ID
- PID11776
- Acronym
- REFLX
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedure RElated Outcomes With the Watchman FLX Left Atrial Appendage Closure Device
- ClinicalTrials.gov ID
- NCT03339193
- Acronym / sponsor ID
- REFLX / PID11776
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- atrial fibrillation, stroke, atrial appendage
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-centre prospective post-market approval of the early experience with the Watchman FLX device for left atrial appendage closure in patients with atrial fibrillation at high risk of thromboembolic stroke and with contraindications to long-term oral antocoagulation therapy.
Detailed description
Principal study aim: To document the impact of the next generation of Watchman LAAC device on key aspects of the implant procedure
Study Rationale: As an interventional procedure it is important that progressive steps are made to make the procedure safer, simpler, faster and more cost-effective. This study will document the impact of introducing the next generation of LAAC device, the Watchman FLX, into a clinical service. It is anticipated that the increased versatility of the Watchman FLX will lead to fewer repositionings and redeployments, shortening procedure time and reducing the mean number of devices opened per case.
Patients to be enrolled: Consecutive patients implanted with the Watchman FLX. All patients will meet current United Kingdom guidelines for LAAC, i.e. have atrial fibrillation, a high risk of thromboembolic stroke (CHA2DS2VASc score >2) and contraindications to long-term oral anticoagulation.
Study design: This is a prospective single-centre observational case-controlled study to be conducted at the John Radcliffe Hospital, Oxford, United Kingdom
Outcomes: Data collected will include patient demographics, left atrial appendage (LAA) dimensions and anatomical description, total procedure duration, device implant time (from introduction of Access sheath to cable release), number of devices opened/ used, number of repositions and redeployments, final position, presence of residual leak, acute complications, peri- and post-procedure antiplatelet and anticoagulant use and 6 week transesophageal echo findings. There will be a particular focus on the need for repositioning and redeployment and how that is undertaken (e.g. advancement of device distally into the LAA).
Timelines: For 20 patients in each group, 7 months from first patient enrolled to final patient undergoing 6 week transesophageal echo (TEE) followup will be required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having LAAC | – | Device: Left atrial appendage closurePatients who meet current clinical criteria for left atrial appendage closure (LAAC), ie have atrial fibrillation, a CHA2DS2-VASc score of 3 or more and a contraindication to long-term oral anticoagulation therapy and who have been approved by the OUH NHS Foundation Trust LAAC Multidisciplinary Team (MDT) as suitable for left atrial appendage occlusion in accordance with National Health Service (NHS) guidelines. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective left atrial appendage occlusion/closure in accordance with UK guidelines
Key inclusion criteria (3 listed)
- Subjects who are eligible for a WATCHMAN FLX device per physician discretion according to current international and local guidelines and currently approved indications
- Subjects who are willing and capable of providing informed consent and participating in all testing associated with this clinical investigation at an approved clinical investigational centre
- Subjects whose age is 18 years or above, or of legal age to give informed consent specific to national law.
Key exclusion criteria (4 listed)
- Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
- Subjects who are unable or not willing to complete the follow-up visits and examination at 6 weeks.
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion).
- Documented life expectancy of less than 12 months.
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 |
|---|---|---|
| Left atrial appendage closurePercutaneous insertion of a Watchman FLX left atrial appendage closure device under general anesthesia with transesophageal echo guidance. | Device | Patients having LAAC |
Primary outcome
Procedural success rates, (redeployments and devices used)
Time frame: Implant procedure
Implant characteristics. This is a descriptive study
Procedural characteristics (including number of repositions),
Time frame: Implant procedure
Implant characteristics. This is a descriptive study
1 secondary outcome
Procedure complications
Time frame: Implant procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Tim Betts, MD study director
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Oxford University Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Procedural success rates, (redeployments and devices used) (time frame: Implant procedure). 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?
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 13 Nov 2017.