Cryoablation + LAA Closure for Atrial Fibrillation (ICE-AFIB Trial)

Recruiting in Palo Alto (17 mi)

+16 other locations

Overseen ByNiv Ad, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: AtriCure, Inc.

No Placebo Group

Trial Summary

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.

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

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

I am 18 years old or older.

I have had atrial fibrillation for a long time.

Exclusion Criteria

I have atrial fibrillation and do not need surgery for blocked arteries or heart valves.

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

I have been diagnosed with a thickened heart muscle that obstructs blood flow.

I had a stroke within the last 6 months or have lasting effects from a past stroke.

I need surgery that is not for heart bypass, valve surgery, or hole in the heart repairs.

I have had heart surgery before.

I experience severe leg pain with minimal physical activity due to poor blood flow.

I have severe heart failure symptoms.

I am on long-term steroid treatment, not just for breathing issues.

I have had a Maze procedure for my heart condition.

I have received radiation therapy to my chest area.

I am currently fighting an infection in my body.

I need medication to manage my irregular heartbeat.

I am currently undergoing chemotherapy.

I need urgent heart surgery due to a severe heart condition.

I have a severe narrowing in my carotid artery.

I need a heart pump or IV medication to help my heart work before surgery.

I have a heart rhythm disorder like Wolff-Parkinson-White syndrome.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: AtriCure CryoICE & AtriClip LAA ExclusionExperimental Treatment1 Intervention

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