intra-procedural intracardiac echocardiography (ICE) probe for Left Atrial Appendage Occlusion

1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
intra-procedural intracardiac echocardiography (ICE) probe - Device
Eligibility
18+
All Sexes
Eligible conditions
Left Atrial Appendage Occlusion

Study Summary

Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether intra-procedural intracardiac echocardiography (ICE) probe will improve 2 primary outcomes in patients with Left Atrial Appendage Occlusion. Measurement will happen over the course of 45 days post procedure.

45 days post procedure
Major complications
Successful implantation of WATCHMAN FLX device

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)

This trial requires 72 total participants across 2 different treatment groups

This trial involves 2 different treatments. Intra-procedural Intracardiac Echocardiography (ICE) Probe is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

left atrial appendage (LAA) occlusion with the WATCHMAN FLX device using (ICE)
Device
100 patients undergoing LAA closure with the WATCHMAN FLX utilizing an intra-procedural ICE probe under moderate sedation.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 45 days post procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 45 days post procedure for reporting.

Who is running the study

Principal Investigator
M. A. A.
Mohamad Adnan Alkhouli, Principal Investigator
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The ability to tolerate the procedure without the need for general anesthesia is assessed by the treating physician(s). show original
The patient will be able to undergo the procedure with moderate sedation. show original
We expect the patient to be able to return for the required 45-day TEE. show original
The patient is eligible to have a WATCHMAN device implanted. show original
The patient can receive short-term anticoagulation therapy. show original
The ability to make a reasoned decision about whether or not to consent to a medical procedure. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for left atrial appendage occlusion?

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Recent findings of this retrospective analysis and historical review are similar, demonstrating an overall success rate of 94% with LAAs as a single or primary therapeutic modality.

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Can left atrial appendage occlusion be cured?

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Data from a recent study confirms that left atrial appendage occlusion can be cured, by a long-term low left atrial mean orifice flow, and low right atrial emptying pressure or rate.

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What causes left atrial appendage occlusion?

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Findings from a recent study demonstrated that left atrial appendage occlusion was not associated with the prevalence of cardiac disorders, which could be an independent cause of left atrial appendage occlusion. Left atrial appendage occlusion might be caused by local mechanical factors.

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What are the signs of left atrial appendage occlusion?

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This case emphasizes that acute heart failure is a transient clinical manifestation of left atrial appendage occlusion despite the presence of a normal left heart. Left atrial appendage occlusion may rarely be a marker of serious underlying disease processes.

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What is left atrial appendage occlusion?

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Left atrial appendage occlusion is a well established therapeutic method for preventing atrial fibrillation after open-heart surgery. The pericardial closure method was the easiest and convenient for the surgical procedure.

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How many people get left atrial appendage occlusion a year in the United States?

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Around 1250 cases of LAAO are diagnosed in the United States each year, making it one of the most commonly performed procedures in American cardiothoracic practices.

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Is intra-procedural intracardiac echocardiography (ice) probe safe for people?

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Intra-procedural [Ipa] ICE can be performed under conscious sedation with very few risks. [Ipa]ICE can be performed at the bedside or in [Ipa]ICE off-pump coronary procedures.

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Has intra-procedural intracardiac echocardiography (ice) probe proven to be more effective than a placebo?

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The use of IntraACoT did not show to be more effective in predicting post-procedural LV function or a decrease in stroke rate compared with an intravenous (IV) saline infusion as a control for the treatment of patients undergoing a TICD procedure. There is a lack of evidence supporting the effectiveness of intra-procedural intracardiac echocardiography.

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Have there been any new discoveries for treating left atrial appendage occlusion?

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There have not been any significant breakthroughs in therapies for left atrial appendage occlusion in recent years. However, it must be acknowledged that there are numerous medications available today which are effective, safe, and inexpensive, and many patients are able to obtain and afford them. Also, there has been an improvement in the quality of left atrial appendage occlusion surgery in recent years, so that surgeons rarely get to see patients who do not want the operation anymore. It is hoped that all of these factors will help to create more effective treatments for left atrial appendage occlusion in the near future.

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What are the common side effects of intra-procedural intracardiac echocardiography (ice) probe?

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ICUS is associated with some common side effects in patients, including periprocedural hypotension, transient left atrial/venous dysfunction, and dyspnea. These side effects occurred in up to 6% of patients.

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What is the average age someone gets left atrial appendage occlusion?

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Left atrial appendage occlusion has been performed on a wide range of ages at both medical institutions. With each year of life, the risk for thrombosis increases and the benefits diminish as left atrial appendage occlusion is performed. At the age of 55, the risk for thrombosis remains greater than the risks at the other ages, making it the right time to consider left atrial appendage occlusion.

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Does intra-procedural intracardiac echocardiography (ice) probe improve quality of life for those with left atrial appendage occlusion?

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In this small pilot study of patients with LAAO, ICPO did not improve symptoms as assessed by SF-36. However, the number of hospital admissions decreased by 43% in patient who received ICPO.

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