Atrial FibrillationNCT05089877
FREEZE-AFIB Post-Market Study
An observational study of Atrial Fibrillation and Atrial Flutter, run by AtriCure, Inc. at 6 sites in United States.
Trial summary
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Surgical Ablation
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 6 sitesUnited States
- Study dates
- 29 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
Who may be able to join
- Subject is greater than or equal to 18 years of age.
- Subject has documented history of atrial fibrillation.
- Subjects who received surgical ablation for their atrial fibrillation using CRYOF and on whom at least the following lesions were performed: Left and right pulmonary vein isolation, roof and floor lines, mitral annulus line and a connecting lesion from left atrial appendage to left pulmonary vein coronary sinus lesion and LAA exclusion , with a lesion duration of at least 2 minutes.
- Stable subject that underwent non-emergent cardiac surgical procedure(s) 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, or coronary artery bypass procedures, or atrial septal defect (ASD) repair
- Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
- Subject is willing and able to provide written informed consent.
- Subject is willing and able to return for scheduled follow-up visits.
Who cannot join
- Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
- Previous left sided ablation procedures procedure.
- Untreated atrial flutter and symptomatic ventricular arrythmia
- Known carotid artery stenosis greater than 80% prior to index ablation procedure.
- Prior history of ischemic stroke or hemorrhagic stroke
- History of MI with ST elevation within 6 weeks prior to the index ablation
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- Documented AF duration of greater than 10 years.
- Large left atrial size i.e., LA diameter >7 cm prior to the index ablation procedure.
- Subjects with active systemic infection prior to index ablation procedure.
- Subjects who had documented severe peripheral arterial occlusive disease defined as claudication with minimal exertion prior to the ablation procedure.
- Subjects with history of renal failure requiring dialysis or hepatic failure prior to the ablation procedure.
- 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.
- Subjects who are pregnant
- Subjects who had preoperative need for mechanical circulatory support or intravenous inotropes.
- Subjects who are on anti-arrhythmic drug therapy for the treatment of another arrhythmia.
- Subjects in currently undergoing chemotherapy.
- Subjects on long term treatment with oral or injected steroids (not including intermittent use of inhaled steroids for respiratory diseases).
- Subjects who had known connective tissue disorders at the time of index ablation procedure
- Subjects who had known hypertrophic obstructive cardiomyopathy at the time of index ablation procedure
- Subjects with known cold agglutinin.
- Subjects who had or tested positive for COVID-19
- Subjects with bleeding disorders and/or inability to receive anticoagulation
- Subjects undergoing aortic dissection surgery as index procedure.
- Cardiac surgical re-intervention since the index cardiac surgery with concomitant AF ablation procedure
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Northwestern University
Evanston, Illinois, 60208
Hartford Hospital
Hartford, Connecticut, 06106
Saint Thomas West Hospital
Nashville, Tennessee, 37205
Yale University School of Medicine
New Haven, Connecticut, 06510
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Outcomes of Surgical AF Ablation Using cryoICE Cryoablation System
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
Read the detailed description
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- Surgical Ablation
- Keywords
- Surgical ablation, Cryo probe
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical AblationDevice
The AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events.
Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events.
Measured: 30 days post procedure
Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed
Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting >30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring.
Measured: 12-24 months post procedure
Secondary outcomes (3)
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs
Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit regardless of Class I or III AADs.
Measured: 12-24 months post procedure
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit in the Absence of Class I or III AADs.
Freedom from any documented AF, AFL, or AT lasting >30 seconds at the last follow-up visit in the absence of Class I or III AADs.
Measured: 12-24 months post procedure
Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure.
Acute procedural success defined as documentation of sinus rhythm at the end of the procedure.
Measured: At end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start29 Apr 2022
- Primary completion31 Mar 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089877
- Sponsor's protocol ID
- CP-2021-02
- Status last verified
- Apr 2023
- First submitted
- 16 Aug 2021
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Surgical AF Ablation Using cryoICE Cryoablation System
- ClinicalTrials.gov ID
- NCT05089877
- Acronym / sponsor ID
- CP-2021-02
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Surgical ablation, Cryo probe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device.
Detailed description
This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
Key inclusion criteria (7 listed)
- Subject is greater than or equal to 18 years of age.
- Subject has documented history of atrial fibrillation.
- Subjects who received surgical ablation for their atrial fibrillation using CRYOF and on whom at least the following lesions were performed: Left and right pulmonary vein isolation, roof and floor lines, mitral annulus line and a connecting lesion from left atrial appendage to left pulmonary vein coronary sinus lesion and LAA exclusion , with a lesion duration of at least 2 minutes.
- Stable subject that underwent non-emergent cardiac surgical procedure(s) 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, or coronary artery bypass procedures, or atrial septal defect (ASD) repair
- Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography or cardiac catheterization performed within 90 days of enrollment as documented in patient medical history).
Key exclusion criteria (25 listed)
- Stand-alone AF without indication(s) for concomitant CABG and/or valve surgery.
- Previous left sided ablation procedures procedure.
- Untreated atrial flutter and symptomatic ventricular arrythmia
- Known carotid artery stenosis greater than 80% prior to index ablation procedure.
- Prior history of ischemic stroke or hemorrhagic stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical AblationThe AtriCure cryoICE® cryoFORMTM cryoablation probe is used in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway. | Device | – |
Primary outcome
Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events.
Time frame: 30 days post procedure
Death, stroke (regardless of level of disability), myocardial infarction, and major bleeding events within 30-days of the index ablation procedure. Measured by number of patients with Treatment-Related Adverse Events.
Freedom From Any Documented AF, AFL or AT Lasting >30 Seconds in the Duration of the Last Follow-up Visit Off Antiarrhythmic Therapy (Except of AADs at Doses Not Exceeding Those Previously Failed
Time frame: 12-24 months post procedure
Freedom from any documented atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) lasting >30 seconds in duration at the last follow-up visit off antiarrhythmic therapy (except of AADs at doses not exceeding those previously failed). Measured by 24-hour Holter Monitoring.
3 secondary outcomes
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit Regardless of Class I or III AADs
Time frame: 12-24 months post procedure
Freedom From Any Documented AF, AFL, or AT Lasting >30 Seconds at the Last Follow-up Visit in the Absence of Class I or III AADs.
Time frame: 12-24 months post procedure
Acute Procedural Success Defined as Documentation of Sinus Rhythm at the End of the Procedure.
Time frame: At end of procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by AtriCure, Inc. at 6 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 25 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: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events. (time frame: 30 days post procedure). 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?
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 13 Jan 2025.