Trial Outcomes & Findings for iCLAS™ for Persistent Atrial Fibrillation (NCT NCT04061603)

Results Overview

Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phrenic nerve injury * Access site complications requiring pharmacological or surgical intervention * Atrio-esophageal fistula * Pericarditis * Heart block requiring a permanent pacemaker * Vagal nerve injury with GI dysmotility * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

215 participants

Primary outcome timeframe

12-months

Results posted on

2026-08-06

Participant Flow

215 patients were enrolled

189 patients were treated with the investigational device

Participant milestones

Participant milestones
Measure	iCLAS Ablation Any enrolled subject (including roll-in subjects) who has the venous access portion of the ablation procedure initiated
Overall Study STARTED	189
Overall Study COMPLETED	175
Overall Study NOT COMPLETED	14

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	iCLAS Ablation n=189 Participants Ablation of the left and right atrium with the Adagio Medical iCLAS System
Age, Continuous	65.5 years STANDARD_DEVIATION 8.4 • n=189 Participants
Sex: Female, Male Female	50 Participants n=189 Participants
Sex: Female, Male Male	139 Participants n=189 Participants
Left Ventricular Ejection Fraction (LVEF)	56 % STANDARD_DEVIATION 7.4 • n=189 Participants

PRIMARY outcome

Timeframe: 12-months

Population: Safety Population: Any enrolled subject (including roll-in subjects) who has the venous access portion of the ablation procedure initiated, regardless of whether the subject receives an ablation with the investigational device

Analysis of the proportion of subjects who are free from device/procedure related Major Adverse Events (MAEs) that occur following the cryoablation procedure. MAEs include any of the following: * Death * Myocardial infarction * Cardiac perforation/pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion of blood products * Mitral or tricuspid valve damage * Symptomatic pulmonary vein stenosis * Severe (≥ 70%) pulmonary vein stenosis * Permanent phrenic nerve injury * Access site complications requiring pharmacological or surgical intervention * Atrio-esophageal fistula * Pericarditis * Heart block requiring a permanent pacemaker * Vagal nerve injury with GI dysmotility * Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) as "probably or definitely related" to the Adagio System

Outcome measures

Outcome measures
Measure	Safety Cohort n=189 Participants Safety Population: Any enrolled subject (including roll-in subjects) who has the venous access portion of the ablation procedure initiated, regardless of whether the subject receives an ablation with the investigational device.
Analysis of the Proportion of Subjects Who Are Free From Device/Procedure Related Major Adverse Events (MAEs) That Occur Following the Cryoablation Procedure	3 Participants

PRIMARY outcome

Timeframe: 12-months

Population: mITT: Any enrolled subject who starts the procedure and receives at least one ablation with the investigational device, excluding the roll-in subjects and subjects who discontinued from the study before 104 days. Also, the subject will have at least one assessment of 24-hour ECG recording (Holter monitor) or 12-lead ECG after the blanking period

Analysis of the proportion of subjects receiving a single cryoablation who are free from any documented left atrial arrhythmia (AF/AFL/AT) following the Blanking Period lasting longer than 30 seconds on a continuous 24-hour ECG recording (Holter monitor). The primary effectiveness endpoint will be based on a centralized core lab interpretation of the recordings used in the endpoint analysis.

Outcome measures

Outcome measures
Measure	Safety Cohort n=137 Participants Safety Population: Any enrolled subject (including roll-in subjects) who has the venous access portion of the ablation procedure initiated, regardless of whether the subject receives an ablation with the investigational device.
Analysis of the Proportion of Subjects Receiving a Single Cryoablation Who Are Free From Any Documented Left Atrial Arrhythmia (AF/AFL/AT) Following the Blanking Period Lasting Longer Than 30 Seconds on a Continuous 24-hour ECG Recording (Holter Monitor).	97 Participants

SECONDARY outcome

Timeframe: 20-minutes following last ablation

Population: mITT: Any enrolled subject who starts the procedure and receives at least one ablation with the investigational device, excluding the roll-in subjects and subjects who discontinued from the study before 104 days. Also, the subject will have at least one assessment of 24-hour ECG recording (Holter monitor) or 12-lead ECG after the blanking period

Percentage of patients with documentation of pulmonary vein isolation (LSPV, LIPV, RSPV, RIPV) and posterior wall isolation (PWI) and cavo-tricuspid isthmus (CTI) bidirectional block (BDB) following the last ablation of PV, PW, and CTI.

Outcome measures

Outcome measures
Measure	Safety Cohort n=137 Participants Safety Population: Any enrolled subject (including roll-in subjects) who has the venous access portion of the ablation procedure initiated, regardless of whether the subject receives an ablation with the investigational device.
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success PVI- LSPV Achieved	94.2 percentage of participants
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success PVI- LIPV Achieved	94.9 percentage of participants
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success PVI- RSPV Achieved	97.8 percentage of participants
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success PVI- RIPV Achieved	97.1 percentage of participants
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success PWI	96.4 percentage of participants
Analysis of the Proportion of Subjects With Acute Procedural (Ablation) Success CTI BDB Achieved	87.2 percentage of participants

Adverse Events

iCLAS Ablation

Serious events: 10 serious events

Other events: 14 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	iCLAS Ablation n=189 participants at risk Ablation of the left and right atrium with the Adagio Medical iCLAS System
Vascular disorders Vascular access site complications	1.6% 3/189 • 12-month
Injury, poisoning and procedural complications Phrenic nerve injury	1.1% 2/189 • 12-month
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.53% 1/189 • 12-month
Nervous system disorders Cerebral infarct or systemic embolism	0.53% 1/189 • 12-month
Injury, poisoning and procedural complications Vascular access site bleeding	0.53% 1/189 • 12-month
Gastrointestinal disorders Esophageal injury	1.1% 2/189 • 12-month

Other adverse events

Other adverse events
Measure	iCLAS Ablation n=189 participants at risk Ablation of the left and right atrium with the Adagio Medical iCLAS System
Vascular disorders Vascular access site complications	3.7% 7/189 • 12-month
Injury, poisoning and procedural complications Phrenic nerve injury	3.7% 7/189 • 12-month

Additional Information

Chief Compliance Officer

Adagio Medical

Phone: 9493292494

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place