Efficacy, SelfICELAANCT04196335
I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
A study testing intra-procedural intracardiac echocardiography in people with Efficacy, Self and Safety Issues, run by Boston Scientific Corporation at 7 sites in 4 countries.
Trial summary
The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Efficacy, Self, Safety Issues
- What is being tested?
- intra-procedural intracardiac echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 29 Jul 2020to 24 Sep 2021
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is of legal age to participate in the study per the laws of their respective geography;
- The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject does not have mitral stenosis or a mechanical heart valve);the subject has not been diagnosed with rheumatic mitral valvular heart disease);
- The subject is deemed by the treating physician to be suitable for the protocol defined pharmacologic regimens;
- The subject has a calculated CHA2DS2-VASc score of 2 or greater;
- The subject is able to undergo ICE examinations;The subject is able to undergo ICE(which will be used during the index procedure) and TEE (which will be performed at 45 days and may also be performed at baseline);
- 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 OAC due to other medical conditions requiring chronic warfarin therapy);
- 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 or has had any documented history of, New York Heart Association Class IV Congestive Heart Failure;
- 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).
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Italy4 sites
Fondazione Toscana Gabriele Monasterio
Massa
Ospedale dell'Angelo
Mestre
Centro Cardiologico Fondazione Monzino
Milan
Ospedale San Bortolo
Vicenza
About this study
The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.
- Conditions
- Efficacy, Self, Safety Issues
- Being tested
- intra-procedural intracardiac echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-procedural intracardiac echocardiographyDevice
Also called Watchman FLX Device
use of intra-procedural intracardiac echocardiography during Watchman FLX devices
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Not described Receives: Device: intra-procedural intracardiac echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Device Leak
Rate of significant leak (>5 mm) as assessed by TEE at 45 days' post-implant.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start29 Jul 2020
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy, SelfStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens Erik Nielsen-Kudsk, MD, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196335
- Sponsor's protocol ID
- S2459
- Acronym
- ICELAA
- Status last verified
- Jun 2022
- First submitted
- 5 Nov 2019
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nielsen-Kudsk JE, Berti S, Caprioglio F, Ronco F, Arzamendi D, Betts T, Tondo C, Christen T, Allocco DJ. Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study. JACC Cardiovasc Interv. 2023 Mar 27;16(6):643-651. doi: 10.1016/j.jcin.2022.10.024. Epub 2023 Feb 8.
PubMed 36764917
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
- ClinicalTrials.gov ID
- NCT04196335
- Acronym / sponsor ID
- ICELAA / S2459
- Conditions
- Efficacy, Self, Safety Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 12 Dec 2019 (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 primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Device: intra-procedural intracardiac echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The subject is of legal age to participate in the study per the laws of their respective geography;
- The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject does not have mitral stenosis or a mechanical heart valve);the subject has not been diagnosed with rheumatic mitral valvular heart disease);
- The subject is deemed by the treating physician to be suitable for the protocol defined pharmacologic regimens;
- The subject has a calculated CHA2DS2-VASc score of 2 or greater;
- The subject is able to undergo ICE examinations;The subject is able to undergo ICE(which will be used during the index procedure) and TEE (which will be performed at 45 days and may also be performed at baseline);
Key exclusion criteria (6 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 OAC due to other medical conditions requiring chronic warfarin therapy);
- 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 or has had any documented history of, New York Heart Association Class IV Congestive Heart Failure;
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 echocardiographyAlso: Watchman FLX Deviceuse of intra-procedural intracardiac echocardiography during Watchman FLX devices | Device | single-arm |
Primary outcome
Rate of Device Leak
Time frame: 45 days
Rate of significant leak (>5 mm) as assessed by TEE at 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 18 Jun 2025.
- Derived from this study: PubMed 36764917Nielsen-Kudsk JE, Berti S, Caprioglio F, Ronco F, Arzamendi D, Betts T, Tondo C, Christen T, Allocco DJ. Intracardiac Echocardiography to Guide Watchman FLX Implantation: The ICE LAA Study. JACC Cardiovasc Interv. 2023 Mar 27;16(6):643-651. doi: 10.1016/j.jcin.2022.10.024. Epub 2023 Feb 8.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jens Erik Nielsen-Kudsk, MD principal investigator
Aarhus University Hospital Skejby
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-procedural intracardiac echocardiography in people with Efficacy, Self and Safety Issues, run by Boston Scientific Corporation at 7 sites in 4 countries.
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 6 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 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy, Denmark, Spain, 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 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?
Rate of Device Leak (time frame: 45 days). 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 NCT04196335, 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 18 Jun 2025.