Atrial FibrillationNCT06007872
Intracardiac Echocardiography Guided Watchman Device Implant
A study testing Intracardiac Echocardiography (ICE) in people with Atrial Fibrillation and Left Atrial Appendage Thrombosis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Appendage Thrombosis
- What is being tested?
- Intracardiac Echocardiography (ICE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial
Who cannot join
- Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
- Patients receiving a concomitant ablation procedure
- Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
- Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Oussama Wazni, MD, 216-444-2131, waznio@ccf.org
Oussama Wazni, MD, MBA
About this study
Official title: Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant
This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.
Read the detailed description
Left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use of oral anticoagulants.
Concurrent procedural TEE is an integral part of the procedure. It is used to guide trans-septal puncture, device sizing and assessment of final adequacy of device implant.
TEE requires the participation and guidance of a cardiac imager and because the TEE probe is in place for a relatively long duration the procedure, the procedure is most commonly performed under general anesthesia. Furthermore TEE can be associated with risk of injury to the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest that TEE may not be necessary for the overall success of the procedure. The objective of the study is to investigate a new work flow that may ultimately demonstrate that intra-procedural TEE may not be necessary, obviating the need for additional personnel, general anesthesia and decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize left atrial anatomy. Smaller studies and case series have reported the use of ICE as an alternative to TEE in guiding Watchman device implant. This has not been compared systematically with TEE in a large patient sample.
- Being tested
- Intracardiac Echocardiography (ICE)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac Echocardiography (ICE)Device
ICE will be used to guide trans-septal puncture and to guide device implant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intracardiac Echocardiography (ICE) Receives: Device: Intracardiac Echocardiography (ICE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance
Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start2 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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.
- More trials run by The Cleveland 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oussama Wazni, The Cleveland Clinic
- Investigators
- Oussama Wazni, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007872
- Sponsor's protocol ID
- 22-1084
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2023
- Last updated
- 21 Oct 2025
- 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 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant
- ClinicalTrials.gov ID
- NCT06007872
- Acronym / sponsor ID
- 22-1084
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Aug 2023 (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 to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.
Detailed description
Left atrial appendage occlusion is approved as an indicated therapy for patients with non valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance of long term use of oral anticoagulants.
Concurrent procedural TEE is an integral part of the procedure. It is used to guide trans-septal puncture, device sizing and assessment of final adequacy of device implant.
TEE requires the participation and guidance of a cardiac imager and because the TEE probe is in place for a relatively long duration the procedure, the procedure is most commonly performed under general anesthesia. Furthermore TEE can be associated with risk of injury to the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest that TEE may not be necessary for the overall success of the procedure. The objective of the study is to investigate a new work flow that may ultimately demonstrate that intra-procedural TEE may not be necessary, obviating the need for additional personnel, general anesthesia and decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize left atrial anatomy. Smaller studies and case series have reported the use of ICE as an alternative to TEE in guiding Watchman device implant. This has not been compared systematically with TEE in a large patient sample.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Intracardiac Echocardiography (ICE)Intracardiac Echocardiography (ICE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial
Key exclusion criteria (4 listed)
- Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.
- Patients receiving a concomitant ablation procedure
- Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures
- Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).
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 |
|---|---|---|
| Intracardiac Echocardiography (ICE)ICE will be used to guide trans-septal puncture and to guide device implant. | Device | Intervention |
Primary outcome
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance
Time frame: During the procedure
Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.
Oussama Wazni, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracardiac Echocardiography (ICE) in people with Atrial Fibrillation and Left Atrial Appendage Thrombosis, run by The Cleveland Clinic at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 21 Oct 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oussama Wazni, MD (216-444-2131, waznio@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Watchman implantation using intracardiac echocardiography (ICE) guidance (time frame: During the procedure). 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 21 Oct 2025.