Cryoablation + LAA Closure for Atrial Fibrillation

(ICE-AFIB Trial)

Recruiting at 16 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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment AtriCure CryoICE & AtriClip LAA Exclusion for Atrial Fibrillation?

Research shows that combining cryoablation (a technique that uses extreme cold to destroy tissue) and left atrial appendage closure is effective in managing stroke risk in patients with atrial fibrillation. Additionally, cryoballoon ablation has been effective in maintaining stable heart rhythms in patients with persistent atrial fibrillation. ^{1 2 3 4 5}

Is cryoablation combined with left atrial appendage closure safe for treating atrial fibrillation?

Research shows that combining cryoablation with left atrial appendage closure is generally safe for patients with atrial fibrillation, with similar rates of complications and no significant increase in stroke risk compared to cryoablation alone. ^{3 5 6 7 8}

How is the Cryoablation + LAA Closure treatment for atrial fibrillation different from other treatments?

This treatment is unique because it combines cryoablation (a technique that uses extreme cold to destroy abnormal heart tissue) with left atrial appendage (LAA) closure, which helps prevent blood clots. This combination aims to both manage the irregular heartbeat and reduce the risk of stroke, offering a comprehensive approach for high-risk atrial fibrillation patients. ^{3 5 8 9 10}

What is the purpose of this trial?

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, in conjunction with Left Atrial Appendage (LAA) exclusion using the AtriClip device.

Research Team

Niv Ad, MD

Principal Investigator

Washington Adventist Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cryoballoon pulmonary vein ablation and left atrial appendage closure combined procedure: A long-term follow-up analysis. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Fourth-Generation Cryoablation Based Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation: First Case Report. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Catheter ablation using the third-generation cryoballoon provides an enhanced ability to assess time to pulmonary vein isolation facilitating the ablation strategy: Short- and long-term results of a multicenter study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Concomitant cryoballoon ablation and percutaneous closure of left atrial appendage in patients with atrial fibrillation. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of atrial fibrillation using argon-based cryoablation during concomitant cardiac procedures. [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Acute procedural and cryoballoon characteristics from cryoablation of atrial fibrillation using the first- and second-generation cryoballoon: a retrospective comparative study with follow-up outcomes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cryoablation Combined with Left Atrial Appendage Closure: A Safe and Effective Procedure for Paroxysmal Atrial Fibrillation Patients. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Navx-guided Cryoablation of Atrial Tachycardia Inside the Left Atrial Appendage. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

Short and midterm results of epi and endocardial cryoablation. [2012]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Left atrial appendage occlusion combined with cryoballoon or radiofrequency ablation: One-year follow-up comparison. [2023]