Left Atrial Appendage OcclusionNCT05136417
Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device
A study testing intra-procedural intracardiac echocardiography (ICE) probe in people with Left Atrial Appendage Occlusion, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ 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 Occlusion
- What is being tested?
- intra-procedural intracardiac echocardiography (ICE) probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jan 2022to 15 Dec 2023
- 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 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 transesophageal echocardiogram (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 in 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
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.
- Conditions
- Left Atrial Appendage Occlusion
- Being tested
- intra-procedural intracardiac echocardiography (ICE) probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-procedural intracardiac echocardiography (ICE) probeDevice
placing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe.
| Study group | Role | What they receive |
|---|---|---|
| left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE) | Experimental | 100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. Receives: Device: intra-procedural intracardiac echocardiography (ICE) probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Implantation of WATCHMAN FLX Device
Number of participants with a successfully implanted WATCHMAN FLX 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 transesophageal echocardiogram (TEE) 45 days post-implant.
Measured: 45 days post procedure
Major Complications
Number of participants who experience major complications defined as 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: up to 7 days post procedure
Secondary outcomes (2)
Procedure Conversion to General Anesthesia
Number of participants who required conversion from moderate sedation to general anesthesia for implant procedure.
Measured: baseline
Iatrogenic Atrial Septal Defect
Number of participants with an iatrogenic atrial septal defect.
Measured: 45 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start4 Jan 2022
- 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Left Atrial Appendage OcclusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT05136417
- Sponsor's protocol ID
- 21-009613
- Status last verified
- Dec 2024
- First submitted
- 25 Nov 2021
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. 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
- ClinicalTrials.gov ID
- NCT05136417
- Acronym / sponsor ID
- 21-009613
- Conditions
- Left Atrial Appendage Occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 29 Nov 2021 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE) | Experimental | Device: intra-procedural intracardiac echocardiography (ICE) probe100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| intra-procedural intracardiac echocardiography (ICE) probeplacing the WATCHMAN FLX device using the intra-procedural intracardiac echocardiography (ICE) probe. | Device | left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE) |
Primary outcome
Successful Implantation of WATCHMAN FLX Device
Time frame: 45 days post procedure
Number of participants with a successfully implanted WATCHMAN FLX 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 transesophageal echocardiogram (TEE) 45 days post-implant.
Major Complications
Time frame: up to 7 days post procedure
Number of participants who experience major complications defined as 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
Procedure Conversion to General Anesthesia
Time frame: baseline
Iatrogenic Atrial Septal Defect
Time frame: 45 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Left Atrial Appendage Occlusion
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Recruiting
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
Atrial Fibrillation (AF), Paroxysmal AF
RecruitingPhase 4
Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC)
Atrial Fibrillation, Left Atrial Appendage Absent
Recruiting
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
Atrial Fibrillation (AF)
Recruiting
Comparison of the Amplatzer Amulet Versus LAmbre Device for Left Atrial Appendage Closure
Coronary Artery Disease
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?
A study testing intra-procedural intracardiac echocardiography (ICE) probe in people with Left Atrial Appendage Occlusion, 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 2024. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2024). 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?
Successful Implantation of WATCHMAN FLX Device (time frame: 45 days post 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 27 Dec 2024.