Cryoablation + LAA Closure for Atrial Fibrillation

(ICE-AFIB Trial)

Not currently recruiting at 17 trial locations

Overseen By Jess Lampert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AtriCure, Inc.

Must not be taking: Anti-arrhythmics, Chemotherapy, Steroids, others

Disqualifiers: Heart failure, Stroke, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intra-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to treating atrial fibrillation, a condition where the heart beats irregularly. It combines two techniques: the AtriCure CryoICE system, which creates precise scars in the heart to restore normal rhythm, and the AtriClip device, which closes off a small part of the heart to prevent stroke. Participants should have persistent atrial fibrillation and be scheduled for open-heart surgery, such as valve repair or coronary bypass. The trial aims to determine if this combined treatment is safe and effective. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on long-term treatment with oral or injected steroids, you may not be eligible to participate.

What prior data suggests that the AtriCure CryoICE system and AtriClip device are safe for atrial fibrillation treatment?

Research has shown that using the AtriCure CryoICE system with the AtriClip device is generally safe for treating atrial fibrillation, a condition that causes an irregular heartbeat. In studies, closing the left atrial appendage (a small pouch in the heart) with the AtriClip succeeded in 97.8% of patients. Importantly, these studies reported no device-related problems, suggesting that most patients handle the treatment well. Combining cryoablation (a procedure that uses cold to destroy tissue) with closing the left atrial appendage has demonstrated similar safety results, making it a promising option for those considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of AtriCure CryoICE and AtriClip LAA Exclusion for atrial fibrillation because it offers a novel approach by integrating two distinct techniques. Unlike traditional methods that might focus solely on medication or catheter ablation, this treatment uses cryoablation to create precise scar patterns in the heart, effectively interrupting faulty electrical signals. Additionally, the AtriClip device provides a physical closure of the left atrial appendage (LAA), which may reduce the risk of stroke. This dual approach aims to not only control arrhythmia but also address associated stroke risks, setting it apart from standard treatments.

What evidence suggests that the AtriCure CryoICE system and AtriClip LAA exclusion are effective for atrial fibrillation?

Research has shown that the AtriCure CryoICE system, used in the Cox-Maze III procedure, effectively treats atrial fibrillation, a type of irregular heartbeat. In this trial, participants will receive the AtriCure CryoICE system performing the Cox-Maze III lesion set alongside LAA exclusion using the AtriClip device. Cryoablation, which involves freezing tissue, can accurately target heart areas to stop abnormal rhythms. The AtriClip device closes off the Left Atrial Appendage (LAA), a small pouch in the heart, with a high success rate of about 95.7%, helping to prevent blood clots. Studies have found that methods like clipping the LAA can be successful up to 98.4% of the time. Together, these treatments aim to manage atrial fibrillation by reducing the risks of blood clots and irregular heartbeats. ^{1 2 5 6 7}

Who Is on the Research Team?

Niv Ad, MD

Principal Investigator

Washington Adventist Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with persistent or long-standing atrial fibrillation who need non-emergency heart surgery, like valve repair/replacement or bypass. They must be able to consent and follow up, have a life expectancy of at least 5 years, and an ejection fraction ≥30%. Excluded are those with severe carotid artery stenosis, active infections, mental impairments affecting study comprehension, pregnancy plans within a year, certain steroid treatments, previous Maze procedures or cardiac surgeries (Redo), ventricular arrhythmia drug therapy needs, specific cardiomyopathies or blood disorders.

Inclusion Criteria

Subject is willing and able to provide written informed consent

My heart pumps well enough (LVEF ≥ 30%) as confirmed by a recent test.

I am scheduled for a heart surgery that includes valve repair or replacement, or bypass.

Exclusion Criteria

I am on dialysis for kidney failure or have liver failure.

Pregnancy or desire to get pregnant within 12-months of the study treatment

I understand the details and importance of this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the AtriCure CryoICE system procedure to perform the Cox-Maze III lesion set and LAA exclusion using the AtriClip device during cardiac surgery

Intra-operative period

1 visit (in-person, surgical procedure)

Follow-up

Participants are monitored for safety and effectiveness, including freedom from AF/AFL/AT and quality of life assessments

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• AtriCure CryoICE & AtriClip LAA Exclusion

Trial Overview The AtriCure CryoICE system's safety and effectiveness in creating Cox-Maze III lesions during heart surgery are being tested. The procedure includes excluding the Left Atrial Appendage using the AtriClip device. This study aims to see if these interventions can help treat atrial fibrillation effectively.

How Is the Trial Designed?

Group I: AtriCure CryoICE & AtriClip LAA Exclusion Experimental Treatment 1 Intervention

AtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.

Who Is Running the Clinical Trial?

AtriCure, Inc.

Lead Sponsor

Trials

43

Recruited

22,800+

Published Research Related to This Trial

In a study of 63 patients undergoing cardiac procedures, argon-based cryoablation for atrial fibrillation (AF) was found to be safe and effective, achieving an 88.5% freedom from AF rate at 12 months.

The procedure had no in-hospital deaths or strokes, although 19% of patients required a permanent pacemaker post-surgery, indicating a generally positive safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. Mack, CA., Milla, F., Ko, W., et al.[2013]

Citations

1. atricure.com atricure.com/patients-caregivers/clinical-evidence/trials-results

Trials with Results | Atrial Fibrillation Treatment This page contains information about clinical trials that are sponsored by AtriCure, Inc. If you wish to learn more, please visit ClinicalTrials.gov.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11329176/

Efficacy of four different left atrial appendage closure ... LAA clipping and LAA excision were both successful LAA closure methods with success rates of 98.4% and 93.1%, respectively. External LAA ligation and stapler ...

3. atricure.com atricure.com/healthcare-professionals/therapies/LAAM

Left Atrial Appendage Management - AtriClip Device The AtriClip device is placed at the base of the left atrial appendage (LAA) excluding it from the circulating blood in the left atrium.

4. withpower.com withpower.com/trial/phase-atrial-fibrillation-2019-ab316

Cryoablation + LAA Closure for Atrial Fibrillation · Info for ... The primary objective of this study is to evaluate the safety and effectiveness of the AtriCure CryoICE system in performing the Cox-Maze III lesion set, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8548185/

Feasibility of the AtriClip Pro Left Atrium Appendage ... The intraprocedural success rate was 95.7%, without any device-related adverse events. Moreover, of 61 patients who underwent postoperative computed tomographic ...

6. atricure.com atricure.com/healthcare-professionals/therapies/LAAM/atriclip-exclusion-system/atriclip-pro-v-device

AtriClip PRO-V Device | LAA Exclusion System The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31292605/

Outcomes of left atrial appendage occlusion using the ... LAA occlusion was achieved in 902 out of 922 patients (97.8%). No device-related adverse events were reported across the studies. The reported ...