Trial Outcomes & Findings for Cryoablation System FIM/CE Mark Study (NCT NCT03723070)

Last Updated: 2025-04-04

Results Overview

Percentage of participants with procedure related adverse events OR device related adverse events OR Serious Adverse device effects including: Death, Myocardial Infarction, Cardiac perforation/pericardial tamponade, Cerebral Infarct or systemic embolism, Major bleeding requiring transfusion of blood products, Mitral or tricuspid valvular damage, phrenic nerve damage causing persistent diaphragmatic paralysis, Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, Air embolism leading to life-threatening event, other serious adverse device effects (SADEs)

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

12 months

Results posted on

2025-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	PV Cryoablation Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Overall Study STARTED	88
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	PV Cryoablation Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	1
Overall Study Ended the study at 1 month follow-up visit as per applicable protocol at that time	6

Baseline Characteristics

Cryoablation System FIM/CE Mark Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PV Cryoablation n=88 Participants Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment New Zealand	15 participants n=5 Participants
Region of Enrollment Netherlands	9 participants n=5 Participants
Region of Enrollment Croatia	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	PV Cryoablation n=88 Participants Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Primary Safety Outcome: Percentage of Participants With Procedure Related Adverse Events OR Device Related Adverse Events OR Serious Adverse Device Effects	50 Participants

PRIMARY outcome

Timeframe: Following the last cryo-application for each of the targeted veins, during the index procedure. Mean procedure time was 118 minutes.

Percentage of patients achieving pulmonary vein isolation defined as entrance and exit block for each of the targeted pulmonary veins following the last ablation application.

Outcome measures

Outcome measures
Measure	PV Cryoablation n=88 Participants Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Acute Procedural Success	87 Participants

PRIMARY outcome

Timeframe: 12 months

Population: In total, 88 subjects were enrolled. Six subjects ended the study at the one month follow-up visit and were therefore not eligible for the analysis. Of the 3 subjects that were withdrawn prior to study completion, one subject experienced a recurrence before being withdrawn and was therefore included in the analysis. The two other subjects were event free at time of study withdrawal.

A treatment failure is defined as a subject being an acute procedural failure, having more than one repeat procedure during the 90-day blanking period or having a documented, symptomatic episode(s) of atrial fibrillation or atrial tachycardia, between 91 and 365 days post index procedure. Occurrence or recurrence of a right atrial arrhythmia is not considered a treatment failure post the 90-day blanking period

Outcome measures

Outcome measures
Measure	PV Cryoablation n=80 Participants Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
12 Month Treatment Success - Percentage of Subjects Free From Arrhythmias at 12 Months	58 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Causally related to procedure

All procedure-related or device related adverse events with causal relationship

Outcome measures

Outcome measures
Measure	PV Cryoablation n=88 Participants Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Secondary Safety Outcome: Number of Procedure-related or Device Related Adverse Events.	12 Adverse Events

SECONDARY outcome

Timeframe: 30 minutes

Population: Out of 88 subjects enrolled in the study, 54 subjects have been enrolled under the protocol requiring a 30 minute waiting period between pulmonary vein isolation and entrance/exit block testing. All subjects for whom at least one additional application was performed minimally 30 minutes after the previous ablation, were considered having a potential reconnection during entrance/exit block testing.

Percentage of subjects that present PV isolation immediately after ablation but show reconnection after 30 minutes during entrance/exit block testing. This outcome is only measured in subjects that were enrolled under the protocol that required a 30 minute waiting period between isolation and verification of isolation.

Outcome measures

Outcome measures
Measure	PV Cryoablation n=54 Participants Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Percentage of Subjects With Isolation Immediately Post Ablation and With Reconnection During the Entrance/Exit Block Testing	7 Participants

Adverse Events

PV Cryoablation

Serious events: 6 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PV Cryoablation n=88 participants at risk Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Nervous system disorders Episodic aphasia	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Hematochezia	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Cholecystitis	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Cholelithiasis	1.1% 1/88 • Number of events 1 • 12 months
Vascular disorders Embolism in right femoral artery	1.1% 1/88 • Number of events 1 • 12 months
Cardiac disorders Atrial Arrhythmia	1.1% 1/88 • Number of events 1 • 12 months

Other adverse events

Other adverse events
Measure	PV Cryoablation n=88 participants at risk Ablation of the ostium of the pulmonary veins (PV) as a means to electrically isolate the veins in the treatment of atrial fibrillation. A cryoablation balloon will be inserted into the left atrium and cryo applications will be administered to create an endocardial thermal injury by using the Cryterion Cardiac Cryoablation System The Cryterion Cardiac Cryoablation System: Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
Skin and subcutaneous tissue disorders Post surgical wound discomfort	2.3% 2/88 • Number of events 2 • 12 months
Vascular disorders Minor oozing/bleeding	3.4% 3/88 • Number of events 3 • 12 months
Cardiac disorders Angina/Chest pain	4.5% 4/88 • Number of events 5 • 12 months
Musculoskeletal and connective tissue disorders Back Pain	2.3% 2/88 • Number of events 2 • 12 months
Cardiac disorders Pericardial effusion	1.1% 1/88 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Hematoma	3.4% 3/88 • Number of events 3 • 12 months
Nervous system disorders Nerve (weakness, palsy)	4.5% 4/88 • Number of events 4 • 12 months
General disorders Adverse reactions	1.1% 1/88 • Number of events 1 • 12 months
Cardiac disorders Adverse reaction - hypotension	3.4% 3/88 • Number of events 3 • 12 months
Nervous system disorders Adverse reaction - neurological	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Adverse reaction Anesthesia/sedation	2.3% 2/88 • Number of events 2 • 12 months
Gastrointestinal disorders Adverse reaction - gastrointestinal	3.4% 3/88 • Number of events 3 • 12 months
Respiratory, thoracic and mediastinal disorders Adverse reaction - pulmonary	1.1% 1/88 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Sore Throat post procedure	1.1% 1/88 • Number of events 1 • 12 months
Cardiac disorders Palpitations	30.7% 27/88 • Number of events 38 • 12 months
Cardiac disorders Atrial Arrhythmia	11.4% 10/88 • Number of events 11 • 12 months
Cardiac disorders Syncope	1.1% 1/88 • Number of events 1 • 12 months
Cardiac disorders Diziness	2.3% 2/88 • Number of events 2 • 12 months
Cardiac disorders Chest Pain	3.4% 3/88 • Number of events 3 • 12 months
Cardiac disorders Dyspnea	1.1% 1/88 • Number of events 1 • 12 months
Cardiac disorders Fatigue/Weakness	3.4% 3/88 • Number of events 3 • 12 months
Cardiac disorders Inability to palpate peripheral arterial pulse	1.1% 1/88 • Number of events 1 • 12 months
Cardiac disorders CVA	1.1% 1/88 • Number of events 1 • 12 months
General disorders Adverse Reaction - Urticaria	1.1% 1/88 • Number of events 1 • 12 months
General disorders Adverse Reaction - Medication	1.1% 1/88 • Number of events 1 • 12 months
General disorders Hipoechogenic lesion in left breast	1.1% 1/88 • Number of events 1 • 12 months
Infections and infestations Fever - Virus	3.4% 3/88 • Number of events 3 • 12 months
Musculoskeletal and connective tissue disorders Ankle Injury	1.1% 1/88 • Number of events 1 • 12 months
Blood and lymphatic system disorders Hypersaturation with warfarin	1.1% 1/88 • Number of events 1 • 12 months
Endocrine disorders Elevated level Thyroid function (T4)	1.1% 1/88 • Number of events 1 • 12 months
Infections and infestations Infection	1.1% 1/88 • Number of events 2 • 12 months
Nervous system disorders Shinlges	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Gastritis	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Dysphagia	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Odynophagia	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Polipectomy	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Heartburn	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Constipation	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Diarrhoea	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Polyp in acsending colon	1.1% 1/88 • Number of events 1 • 12 months
Renal and urinary disorders Urinary Infection	1.1% 1/88 • Number of events 1 • 12 months
Renal and urinary disorders Positive urine culture	1.1% 1/88 • Number of events 1 • 12 months
Renal and urinary disorders Benign renal cyst L) kidney	1.1% 1/88 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Muskuloskeletal	3.4% 3/88 • Number of events 3 • 12 months
Infections and infestations Pharyngitis	1.1% 1/88 • Number of events 1 • 12 months
Vascular disorders Epistaxis	1.1% 1/88 • Number of events 1 • 12 months
Eye disorders Cataract	1.1% 1/88 • Number of events 1 • 12 months
Eye disorders Conjunctavitis	1.1% 1/88 • Number of events 1 • 12 months
Endocrine disorders Type 2 Diabetes Mellitus	1.1% 1/88 • Number of events 1 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular lymphoma	1.1% 1/88 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Haematoma of the right upper arm	1.1% 1/88 • Number of events 1 • 12 months
Infections and infestations sinusitis	1.1% 1/88 • Number of events 1 • 12 months
Gastrointestinal disorders Tooth Pain	1.1% 1/88 • Number of events 1 • 12 months

Additional Information

Clinical Trial Manager

Boston Scientific

Phone: +32 470 991143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place