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Procedure

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

N/A
Waitlist Available
Led By Niv Ad, MD
Research Sponsored by AtriCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable Subject that is scheduled to undergo non-emergent cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including open-heart surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or replacement, Tricuspid valve repair or replacement, and Coronary artery bypass procedures
Subject is greater than or equal to 18 years of age
Must not have
Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
Renal failure requiring dialysis or hepatic failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new heart surgery technique that uses a freezing device to create scar tissue to block off abnormal electrical pathways in the heart, in addition to sealing off the left atrial appendage to prevent blood clots.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include typical risks associated with surgical procedures such as bleeding, infection at the incision site; reactions to anesthesia; damage to nearby organs; blood clots leading to stroke or other complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a heart surgery that includes valve repair or replacement, or bypass.
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I am 18 years old or older.
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I have had atrial fibrillation for a long time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have atrial fibrillation and do not need surgery for blocked arteries or heart valves.
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I am on dialysis for kidney failure or have liver failure.
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I have been diagnosed with a thickened heart muscle that obstructs blood flow.
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I had a stroke within the last 6 months or have lasting effects from a past stroke.
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I need surgery that is not for heart bypass, valve surgery, or hole in the heart repairs.
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I have had heart surgery before.
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I experience severe leg pain with minimal physical activity due to poor blood flow.
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I have severe heart failure symptoms.
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I am on long-term steroid treatment, not just for breathing issues.
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I have had a Maze procedure for my heart condition.
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I have received radiation therapy to my chest area.
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I am currently fighting an infection in my body.
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I need medication to manage my irregular heartbeat.
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I am currently undergoing chemotherapy.
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I need urgent heart surgery due to a severe heart condition.
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I have a severe narrowing in my carotid artery.
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I need a heart pump or IV medication to help my heart work before surgery.
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I have a heart rhythm disorder like Wolff-Parkinson-White syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Acute Coryza
Secondary study objectives
Acute procedural success (Effectiveness)
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)
Composite post-procedure MAE rate (Safety).
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

AtriCure, Inc.Lead Sponsor
42 Previous Clinical Trials
18,621 Total Patients Enrolled
27 Trials studying Atrial Fibrillation
9,497 Patients Enrolled for Atrial Fibrillation
Niv Ad, MDPrincipal InvestigatorWashington Adventist Hospital
6 Previous Clinical Trials
617 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
186 Patients Enrolled for Atrial Fibrillation

Media Library

AtriCure CryoICE & AtriClip LAA Exclusion (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03732794 — N/A
Atrial Fibrillation Research Study Groups: AtriCure CryoICE & AtriClip LAA Exclusion
Atrial Fibrillation Clinical Trial 2023: AtriCure CryoICE & AtriClip LAA Exclusion Highlights & Side Effects. Trial Name: NCT03732794 — N/A
AtriCure CryoICE & AtriClip LAA Exclusion (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03732794 — N/A
~22 spots leftby Nov 2025
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