Trial Outcomes & Findings for FREEZE-AFIB Post-Market Study (NCT NCT05089877)

Last Updated: 2025-01-13

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

39 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2025-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Non-Randomized, Single Arm Study Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
Overall Study STARTED	39
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Randomized, Single Arm Study n=39 Participants Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
Age, Categorical <=18 years	0 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Age, Categorical Between 18 and 65 years	13 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Age, Categorical >=65 years	20 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Age, Continuous	68.7 years n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Sex: Female, Male Female	8 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Sex: Female, Male Male	25 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) Asian	0 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) Black or African American	1 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) White	31 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) More than one race	0 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=33 Participants • Out of 39 participants, some participants were lost to follow up and some did not meet inclusion criteria.
Region of Enrollment United States	39 participants n=39 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Outcome measures

Outcome measures
Measure	Non-Randomized, Single Arm Study n=33 Participants Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
Freedom From Death, Stroke (Regardless of Level of Disability), Myocardial Infarction, and Major Bleeding Events.	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Non-Randomized, Single Arm Study n=28 Participants Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
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	25 Participants

SECONDARY outcome

Timeframe: 12-24 months post procedure

Freedom from any documented AF, AFL, or AT lasting \>30 seconds at the last follow-up visit regardless of Class I or III AADs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At end of procedure

Acute procedural success defined as documentation of sinus rhythm at the end of the procedure.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 12-24 months post procedure

Freedom from pacemaker implant or overall device or Surgical Ablation procedures Related to Adverse Events

Outcome measures

Outcome data not reported

Adverse Events

Non-Randomized, Single Arm Study

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Non-Randomized, Single Arm Study n=33 participants at risk Patients who have undergone concomitant surgical AF ablation using the CRYOF device under investigation.
Cardiac disorders Complete Heart Block	6.1% 2/33 • At time of procedure
Cardiac disorders Aneurysm	3.0% 1/33 • At time of procedure
Cardiac disorders Atrioventricular Block	3.0% 1/33 • At time of procedure
Cardiac disorders Bradycardia	3.0% 1/33 • At time of procedure
Cardiac disorders Pericarditis	3.0% 1/33 • At time of procedure
Respiratory, thoracic and mediastinal disorders Pneumonia	3.0% 1/33 • At time of procedure
Cardiac disorders Sick Sinus Syndrome	3.0% 1/33 • At time of procedure
Cardiac disorders Other	6.1% 2/33 • At time of procedure
Metabolism and nutrition disorders Other	3.0% 1/33 • At time of procedure
Renal and urinary disorders Acute Kidney Injury	3.0% 1/33 • At time of procedure

Other adverse events

Adverse event data not reported

Additional Information

Nfii Ndikintum, VP of Clinical Affairs and Biometerics

AtriCure

Phone: 5136448192

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place