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Atrial Fibrillation (AF)ICE-AFIBNCT03732794

AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment

A study testing AtriCure CryoICE & AtriClip LAA Exclusion in people with Atrial Fibrillation (AF) and Persistent Atrial Fibrillation, run by AtriCure, Inc. at 15 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AtriCure CryoICE & AtriClip LAA Exclusion
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
15 sitesUnited States
Study dates
30 Jan 2019to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is greater than or equal to 18 years of age
  • Subject has history of persistent or long-standing persistent atrial fibrillation as defined by the 2017 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/ European Cardiac Arrhythmia Society (ECAS) Guidelines
  • 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
  • Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 60 days of enrollment as documented in patient medical history)
  • Subject is willing and able to provide written informed consent
  • Subject has a life expectancy of at least 5 years
  • Subject is willing and able to return for scheduled follow-up visits.

Who cannot join

  • Stand-alone AF without indication(s) for concomitant Coronary Artery Bypass Graft (CABG) and/or valve surgery
  • Previous surgical Maze procedure
  • Wolff-Parkinson-White syndrome or other Supra-Ventricular arrhythmia, Atrioventricular (AV) nodal reentry
  • Prior cardiac surgery (Redo)
  • Subjects requiring surgery other than CABG and/or cardiac valve surgery and/or patent foramen ovale repair, and/or atrial septal defect repair.
  • Class IV New York Heart Association (NYHA) heart failure symptoms
Show all 26Show fewer
  • Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurological deficit
  • Documented ST-segment elevation Myocardial Infarction (MI) within the 6 weeks prior to study enrollment
  • Need for emergent cardiac surgery (i.e. cardiogenic shock)
  • Known carotid artery stenosis greater than 80%
  • Documented AF duration of greater than ten years
  • LA diameter >7 cm by Transthoracic echocardiography (TTE)
  • Current diagnosis of active systemic infection
  • Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
  • Renal failure requiring dialysis or hepatic failure
  • A known drug and/or alcohol addiction
  • Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
  • Pregnancy or desire to get pregnant within 12-months of the study treatment
  • Preoperative need for an intra-aortic balloon pump or intravenous inotropes
  • Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
  • Subjects who have been treated with thoracic radiation
  • Subjects in current chemotherapy
  • Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases)
  • Subjects with known connective tissue disorders
  • Subjects with known hypertrophic obstructive cardiomyopathy
  • Subjects with known cold agglutinin

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University Of Maryland

    Baltimore, Maryland, 21201

  • Northwestern Medicine

    Chicago, Illinois, 60611

  • Franciscan Health

    Indianapolis, Indiana, 46237

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • UCLA Medical Center

    Los Angeles, California, 90095

  • West Virginia University

    Morgantown, West Virginia, 26506

  • St Thomas West Hospital

    Nashville, Tennessee, 37205

  • Mount Sinai Icahn School of Medicine

    New York, New York, 10029

  • NYP-Weill Cornell

    New York, New York, 10065

  • Northwell Health Systems

    New York, New York, 10075

  • Deaconess Gateway Hospital

    Newburgh, Indiana, 47630

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • St. Joseph Hospital Health Center

    Syracuse, New York, 13203

  • Washington Adventist Hospital

    Washington D.C., District of Columbia, 20912

Other trials in United States

About this study

Official title: AtriCure CryoICE Lesions for Persistent and Long-standing Persistent Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery

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.

Read the detailed description

The AtriCure CryoICE Ablation System is being studied to ablate cardiac tissue during surgery for the treatment of Persistent and Long-standing Persistent atrial fibrillation in open concomitant cardiac surgery.

The effectiveness of the device will be demonstrated by establishing that the device effectively eliminates persistent and long-standing persistent atrial fibrillation in a clinically significant proportion of treated patients.

Being tested
AtriCure CryoICE & AtriClip LAA Exclusion
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtriCure CryoICE & AtriClip LAA ExclusionDevice

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

Study groups in NCT03732794
Study groupRoleWhat they receive
AtriCure CryoICE & AtriClip LAA ExclusionExperimentalAtriCure CryoICE system performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
Receives: Device: AtriCure CryoICE & AtriClip LAA Exclusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT)

    Freedom from AF/AFL/AT lasting >30 seconds in duration 6 through 12-months following the ablation procedure in the absence of Class I or III antiarrhythmic drugs (AADs).

    Measured: 12 months

  2. Safety Endpoint: composite acute major adverse event (MAE) rate

    The composite acute major adverse event (MAE) rate, within 30-days post-procedure and deaths after 30-days if death is procedure related.

    Measured: 30 days

Secondary outcomes (7)

  1. Composite post-procedure MAE rate (Safety).

    Long-term safety based on MAE rate at 12-months post-procedure

    Measured: 12 months

  2. Pacemaker implantation (Safety).

    Percentage of implantation of a permanent pacemaker either in the operative period (<30 days postoperative) or at any time during follow-up period.

    Measured: 12 months

  3. Overall Serious Adverse Event (SAE) rate (Safety)

    Long-term safety based on SAE rate at 12-months post-procedure

    Measured: 12 months

  4. Freedom from AF/AFL/AT in presence of previously failed Class I or III AADs (Effectiveness)

    Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure in presence of previously failed Class I or III AADs.

    Measured: 12 months

  5. Freedom from AF/AFL/AT regardless of Class I or III AADs (Effectiveness)

    Freedom from AF/AFL/AT lasting >30 seconds in duration 12-months following the ablation procedure regardless of Class I or III AADs.

    Measured: 12 months

  6. Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score (Effectiveness)

    Based on composite score (0-100). A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered).

    AFEQT Evaluates Health Related Quality of Life (HRQoL) across three domains Symptoms - Four questions specifically targeted to assess AF related symptoms Daily Activities - Eight questions that evaluate daily function in AF patients Treatment Concerns - Six questions that assess AF treatment concerns in patients The overall composite score and domains will be summarized by presenting the means, medians, standard deviations, interquartile ranges, minimum, and maximum

    Measured: 12 months

  7. Acute procedural success (Effectiveness)

    Absence of AF at end of procedure

    Measured: Intra-operative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start30 Jan 2019
  3. Primary completion27 Jun 2024
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03732794
Sponsor's protocol ID
CP2018-1
Acronym
ICE-AFIB
Status last verified
Oct 2024
First submitted
5 Nov 2018
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The study protocol, Statistical Analysis Plan (SAP), and Informed Consent (ICF) will be shared at the completion of the study.

Publications

  • Ad N, Romano MA, Bolling S, Zhou Z, McCarthy P, Malaisrie C, Pham DT, Wei L, Boateng P, El-Eshmawi A, Patel N, Taylor J Jr, Rodriguez E, Shemin R, Crestanello J, Gammie JS, Girardi L, Lau C, Davis JR, Heimes J, Cox J, Gerdisch M. The ICE-AFIB trial: A multicenter prospective investigational device exemption (IDE) trial using cryosurgical ablation for atrial fibrillation during concomitant cardiac surgery. J Thorac Cardiovasc Surg. 2026 Apr;171(4):927-935.e10. doi: 10.1016/j.jtcvs.2025.10.023. Epub 2025 Oct 23.

    PubMed 41138810

Questions about this trial

What is this clinical trial studying?

A study testing AtriCure CryoICE & AtriClip LAA Exclusion in people with Atrial Fibrillation (AF) and Persistent Atrial Fibrillation, run by AtriCure, Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint: Freedom from AF/Atrial Flutter (AFL)/Atrial Tachycardia (AT) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03732794, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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