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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
ICE-AFIB Trial 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.Check my eligibility
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.See study design
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.
ICE-AFIB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a heart surgery that includes valve repair or replacement, or bypass.
Select...
I am 18 years old or older.
Select...
I have had atrial fibrillation for a long time.
ICE-AFIB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)
Acute Coryza
Secondary outcome measures
Acute procedural success (Effectiveness)
Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)
Composite post-procedure MAE rate (Safety).
+4 moreICE-AFIB 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.
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Who is running the clinical trial?
AtriCure, Inc.Lead Sponsor
41 Previous Clinical Trials
17,321 Total Patients Enrolled
27 Trials studying Atrial Fibrillation
8,277 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on dialysis for kidney failure or have liver failure.I understand the details and importance of this study.I have been diagnosed with a thickened heart muscle that obstructs blood flow.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.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 had a heart attack within the last 6 weeks.You have a known connective tissue disorder.I have atrial fibrillation and do not need surgery for blocked arteries or heart valves.You are expected to live for at least 5 more years.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.You have been diagnosed with atrial fibrillation for more than ten years.I am 18 years old or older.You have a known addiction to drugs or alcohol.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.You have a condition called cold agglutinin.I am currently undergoing chemotherapy.I have had atrial fibrillation for a long time.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.Your heart's size is larger than 7 cm when measured by a special heart ultrasound called Transthoracic echocardiography (TTE).
Research Study Groups:
This trial has the following groups:- Group 1: AtriCure CryoICE & AtriClip LAA Exclusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the maximum capacity of patients enrolled in this medical experiment?
"Affirmative, clinicaltrials.gov indicates that this research is actively searching for participants; the trial was first published on January 30th 2019 and most recently updated on September 29th 2022. 150 individuals need to be enrolled from 18 separate medical sites."
Answered by AI
Are there any remaining opportunities to take part in this research project?
"As indicated by clinicaltrials.gov, this trial is still in search of patients who meet the inclusion criteria. The study was published on January 30th 2019 and its contents were last edited on September 29th 2022."
Answered by AI
What are the various sites where this trial is being conducted?
"USC, WVU and Mission Hospital are three anchor sites for this project. A further 18 medical facilities form the periphery of clinical operations."
Answered by AI
What are the stated objectives of this research endeavor?
"As reported by the trial sponsor, AtriCure Inc., the primary outcome measure of this study will be monitored over a month-long period and concern freedom from atrial fibrillation/flutter (AFL)/atrial tachycardia (AT). Additionally, secondary outcomes such as freedom from AF/AFL/AT in presence of previously failed Class I or III AADs regardless of duration, pacemaker implantation rate during both operative and follow-up periods are being evaluated."
Answered by AI
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