Trial Outcomes & Findings for Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures (NCT NCT04087122)

Results Overview

Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation

Results posted on

2022-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Esophageal Warming Patients receive the Attune Medical Esophageal Heat Transfer Device
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esophageal Warming n=20 Participants Patients receive the Attune Medical Esophageal Heat Transfer Device
Age, Continuous	68.5 years STANDARD_DEVIATION 8.4 • n=20 Participants
Sex: Female, Male Female	11 Participants n=20 Participants
Sex: Female, Male Male	9 Participants n=20 Participants

PRIMARY outcome

Timeframe: Study Day 1 for all patients enrolled, during left atrial ablation procedures using cryoablation

Total time of active ablation procedure measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)

Outcome measures

Outcome measures
Measure	Esophageal Warming n=20 Participants Patients receiving the Attune Medical Esophageal Heat Transfer Device
Total Time of Active Ablation Procedure	126 minutes Interval 112.0 to 139.0

SECONDARY outcome

Timeframe: Study Day 1 for all patients enrolled from patient entry to Electrophysiology (EP) lab until post procedure discharge to Post-Anesthesia Care Unit (PACU)]

Total procedure time from patient entry to Electrophysiology (EP) lab until discharge to Post-Anesthesia Care Unit (PACU)

Outcome measures

Outcome measures
Measure	Esophageal Warming n=20 Participants Patients receiving the Attune Medical Esophageal Heat Transfer Device
Total Procedure Time	126 minutes Interval 112.0 to 139.0

SECONDARY outcome

Timeframe: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation

Number of procedural pauses during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)

Outcome measures

Outcome measures
Measure	Esophageal Warming n=20 Participants Patients receiving the Attune Medical Esophageal Heat Transfer Device
Number of Procedural Pauses During Left Atrial Instrumentation	0 Procedural pauses Interval 0.0 to 16.8

SECONDARY outcome

Timeframe: Study Day 1 for all patients, during left atrial ablation procedures using cryoablation

Total duration of fluoroscopy use during left atrial instrumentation measured from trans-septal puncture to achievement of Pulmonary Vein Isolation (PVI)

Outcome measures

Outcome measures
Measure	Esophageal Warming n=20 Participants Patients receiving the Attune Medical Esophageal Heat Transfer Device
Total Duration of Fluoroscopy Use	23.4 minutes Standard Deviation 7.8

Adverse Events

Esophageal Warming

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rebekah Smith, RN, BSN

Valley Health

Phone: 540-536-5547

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place