Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE ProbeNCT04569734
The ICE WATCHMAN Trial
An observational study of Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe, run by Mayo Clinic at 2 sites in United States.
Trial summary
The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe
- What is being tested?
- WATCHMAN device implant procedure utilizing ICE probe
- Type of treatment
- Surgery or procedure
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Sep 2020to 15 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participation in the study is based on institutional standard of care practice for assessment of WATCHMAN eligibility. Patients that are being considered for LAA Closure with WATCHMAN device implant based on a history of non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2VASc score >2 but have an appropriate rationale to seek a non-pharmacologic alternative to anti-thrombotic therapy due to risks of anti-thrombotic therapy. Patients should be able to tolerate the WATCHMAN device implant procedure without the need for general anesthesia.
Who may be able to join
- The patients is eligible to undergo WATCHMAN device implant procedure
- The patient is eligible for short term anticoagulation therapy
- Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s)
- Ability to give informed consent for the procedure
- The patient is able and willing to undergo the procedure under moderate sedation
- The patient is able and willing to return for required 45-day TEE.
Who cannot join
- Patient has contraindication for short term anticoagulation
- The patient has history of a hypercoagulable state per medical record documentation
- Pregnancy or planning to get pregnant during the investigation.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Pacific Heart Institute
Santa Monica, California, 98404
About this study
Official title: Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study (Data Coordinating Center)
The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By eliminating the need for general anesthesia, the hope is to show a reduction in procedural time, decrease use of supplemental invasive procedures (central venous line, invasive arterial pressure monitoring and transesophageal echocardiography) and quicker patient recovery time. This approach can decrease healthcare resource utilization and safely simplify left atrial appendage closure with the WATCHMAN device.
Read the detailed description
The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation. The primary feasibility endpoint will be ability to successfully implant the WATCHMAN device. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant. The primary safety endpoint will be a composite of major complications (major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death). Additional measured end points will be: freedom from conversion to general anesthesia and/or standard TEE during implant, the incidence and the size of iatrogenic atrial septal defect on 45 day TEE. The ICE procedural images will also be collected and analyzed by an independent committee composed of non-implanting interventionalist, and an imaging specialist. The images will be graded in quality as optimal (TEE equivalent), acceptable (adequate but not as detailed as TEE), and inadequate. This prospective study, along with its endpoints will be registered in clinicaltrials.gov.
- Conditions
- Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe
- Being tested
- WATCHMAN device implant procedure utilizing ICE probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN device implant procedure utilizing ICE probeProcedure or surgery
Also called WATCHMAN
The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment Group | Determination for participation in the study is based on institutional standard of care practice for assessment of WATCHMAN eligibility. Patients that are being considered for LAA Closure with WATCHMAN device implant based on a history of non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2VASc score >2 but have an appropriate rationale to seek a non-pharmacologic alternative to anti-thrombotic therapy due to risks of anti-thrombotic therapy. Patients should be able to tolerate the WATCHMAN device implant procedure without the need for general anesthesia. Receives: Procedure: WATCHMAN device implant procedure utilizing ICE probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully implant the WATCHMAN device
Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant
Measured: 45 days post-implant
Absence of a composite of major complications
Absence of a composite of major complications such major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death)
Measured: 7 days post-implant
Absence of a composite of major complications
Absence of a composite of major complications such major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death)
Measured: 45 days post-implant
Secondary outcomes (2)
Freedom from conversion to general anesthesia and/or standard TEE during implant
Freedom from conversion to general anesthesia and/or standard TEE during implant
Measured: During procedure
Freedom from the incidence and the size of iatrogenic atrial septal defect
Freedom from the incidence and the size of iatrogenic atrial septal defect on 45 day TEE
Measured: 45 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start22 Sep 2020
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE ProbeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Adnan Alkhouli, Mayo Clinic
- Investigators
- Mohamad Adnan Alkhouli, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569734
- Sponsor's protocol ID
- 19-012524
- Status last verified
- Dec 2023
- First submitted
- 24 Sep 2020
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study (Data Coordinating Center)
- ClinicalTrials.gov ID
- NCT04569734
- Acronym / sponsor ID
- 19-012524
- Conditions
- Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 30 Sep 2020 (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.
The aim of this multi-center study will be to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance. By eliminating the need for general anesthesia, the hope is to show a reduction in procedural time, decrease use of supplemental invasive procedures (central venous line, invasive arterial pressure monitoring and transesophageal echocardiography) and quicker patient recovery time. This approach can decrease healthcare resource utilization and safely simplify left atrial appendage closure with the WATCHMAN device.
Detailed description
The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation. The primary feasibility endpoint will be ability to successfully implant the WATCHMAN device. Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant. The primary safety endpoint will be a composite of major complications (major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death). Additional measured end points will be: freedom from conversion to general anesthesia and/or standard TEE during implant, the incidence and the size of iatrogenic atrial septal defect on 45 day TEE. The ICE procedural images will also be collected and analyzed by an independent committee composed of non-implanting interventionalist, and an imaging specialist. The images will be graded in quality as optimal (TEE equivalent), acceptable (adequate but not as detailed as TEE), and inadequate. This prospective study, along with its endpoints will be registered in clinicaltrials.gov.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment Group | – | Procedure: WATCHMAN device implant procedure utilizing ICE probeDetermination for participation in the study is based on institutional standard of care practice for assessment of WATCHMAN eligibility. Patients that are being considered for LAA Closure with WATCHMAN device implant based on a history of non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2VASc score >2 but have an appropriate rationale to seek a non-pharmacologic alternative to anti-thrombotic therapy due to risks of anti-thrombotic therapy. Patients should be able to tolerate the WATCHMAN device implant procedure without the need for general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participation in the study is based on institutional standard of care practice for assessment of WATCHMAN eligibility. Patients that are being considered for LAA Closure with WATCHMAN device implant based on a history of non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism based on CHADS2VASc score >2 but have an appropriate rationale to seek a non-pharmacologic alternative to anti-thrombotic therapy due to risks of anti-thrombotic therapy. Patients should be able to tolerate the WATCHMAN device implant procedure without the need for general anesthesia.
Key inclusion criteria (6 listed)
- The patients is eligible to undergo WATCHMAN device implant procedure
- The patient is eligible for short term anticoagulation therapy
- Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s)
- Ability to give informed consent for the procedure
- The patient is able and willing to undergo the procedure under moderate sedation
Key exclusion criteria (3 listed)
- Patient has contraindication for short term anticoagulation
- The patient has history of a hypercoagulable state per medical record documentation
- Pregnancy or planning to get pregnant during the investigation.
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 device implant procedure utilizing ICE probeAlso: WATCHMANThe study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation. | Procedure or surgery | Experimental: Treatment Group |
Primary outcome
Successfully implant the WATCHMAN device
Time frame: 45 days post-implant
Implant success is defined as confirmation of the device-specified release PASS (Position, Anchor, Size, Seal) criteria, successful device release, and adequate seal (defined as a residual leak <5 mm) as assessed by a core lab interpretation of the TEE 45 days post-implant
Absence of a composite of major complications
Time frame: 7 days post-implant
Absence of a composite of major complications such major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death)
Absence of a composite of major complications
Time frame: 45 days post-implant
Absence of a composite of major complications such major bleeding [intracranial bleeding, or bleeding requiring blood transfusion], pericardial effusion requiring pericardiocentesis or surgery, device embolization, procedural-related stroke, or procedural related death)
2 secondary outcomes
Freedom from conversion to general anesthesia and/or standard TEE during implant
Time frame: During procedure
Freedom from the incidence and the size of iatrogenic atrial septal defect
Time frame: 45 days post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Mohamad Adnan Alkhouli, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Atrial Appendage Closure With WATCHMAN Device Utilizing an Intra-procedural ICE Probe, run by Mayo Clinic at 2 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 6 inclusion and 3 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 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successfully implant the WATCHMAN device (time frame: 45 days post-implant). The study lists 3 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 27 Dec 2023.