Trial Outcomes & Findings for Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS) (NCT NCT01456949)

Last Updated: 2025-02-13

Results Overview

Evaluated by assessing the rate of subjects free of chronic treatment failure with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). Chronic treatment failure is defined as: * Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR * Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)

Recruitment status

COMPLETED

Study phase

Target enrollment

402 participants

Primary outcome timeframe

Through 36 months

Results posted on

2025-02-13

Participant Flow

The first subjects was enrolled on 26 June 2012 and the first study cryoablation occurred on 28 June 2012. The last subject was enrolled on 21 August 2014 and the final study cryoablation occurred on 14 October 2014. As this was a single arm study, all subjects enrolled were planned to have a cryoablation procedure.

Participant milestones

Participant milestones
Measure	Single Arm Cryoablation Medtronic Arctic Front® Cardiac CryoAblation System: Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Enrollment STARTED	402
Enrollment Treated	359
Enrollment Modified Intent to Treat Group (mITT)	354
Enrollment COMPLETED	365
Enrollment NOT COMPLETED	37
Study Cryoablation Procedure & Follow-up STARTED	365
Study Cryoablation Procedure & Follow-up 3-month Follow-up Visit Completed	344
Study Cryoablation Procedure & Follow-up 6-month Follow-up Visit Completed	342
Study Cryoablation Procedure & Follow-up 12-month Follow-up Visit Completed	325
Study Cryoablation Procedure & Follow-up 24-month Follow-up Visit Completed	309
Study Cryoablation Procedure & Follow-up 36-month Follow-up Visit Completed	298
Study Cryoablation Procedure & Follow-up COMPLETED	303
Study Cryoablation Procedure & Follow-up NOT COMPLETED	62

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Cryoablation Medtronic Arctic Front® Cardiac CryoAblation System: Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
Enrollment PI death- incomplete data	6
Enrollment Death	1
Enrollment I/E criteria not met prior to procedure	13
Enrollment Physician Decision	10
Enrollment Withdrawal by Subject	7
Study Cryoablation Procedure & Follow-up Death	5
Study Cryoablation Procedure & Follow-up Withdrawal by Subject	23
Study Cryoablation Procedure & Follow-up Lost to Follow-up	11
Study Cryoablation Procedure & Follow-up Physician Decision	1
Study Cryoablation Procedure & Follow-up Subject Relocation	10
Study Cryoablation Procedure & Follow-up Failure to maintain study compliance	2
Study Cryoablation Procedure & Follow-up Rollover not included in completer total	6
Study Cryoablation Procedure & Follow-up Treated did not meet I/E criteria	4

Baseline Characteristics

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Intent to Treat Group (mITT) n=354 Participants Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
Age, Continuous	60.3 Years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants
Sex: Female, Male Male	234 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Asian	5 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Hispanic or Latino	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · White or Caucasian	328 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Other race	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnic Origin · Unknown/Unreported	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through 36 months

Population: Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.

Outcome measures

Outcome measures
Measure	Modified Intent to Treat Group (mITT) n=354 Participants Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) Through 36 Months	66.9 Percentage of participants Interval 61.6 to 71.7

PRIMARY outcome

Timeframe: 12 Months

Population: Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.

Demonstrate safety (through 12 months) of Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the rate of subjects experiencing Cryoablation Procedure Events (CPEs) with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs).

Outcome measures

Outcome measures
Measure	Modified Intent to Treat Group (mITT) n=354 Participants Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
Safety: Percentage of Participants Experiencing Cryoablation Procedure Events (CPEs) Through 12 Months	2.3 Percentage of participants Interval 1.1 to 4.5

SECONDARY outcome

Timeframe: Annually, through 3 years

Population: Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.

Freedom from Major Atrial Fibrillation Event (MAFE): A MAFE is a serious adverse event (SAE) which has not been categorized as a cryoablation procedure event.

Outcome measures

Outcome measures
Measure	Modified Intent to Treat Group (mITT) n=354 Participants Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years. Freedom from MAFEs in mITT subjects at 1 year	90.3 Percentage of participants Interval 86.6 to 92.9
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years. Freedom from MAFEs in mITT subjects at 2 years	83.2 Percentage of participants Interval 78.8 to 86.8
Chronic Safety: Percentage of Participants Free From Major Atrial Fibrillation Events (MAFE) at 1, 2 and 3 Years. Freedom from MAFEs in mITT subjects at 3 years	77.8 Percentage of participants Interval 72.9 to 81.9

SECONDARY outcome

Timeframe: Annually, at 1 and 2 years

Population: Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.

Freedom from chronic treatment failure, defined as: * Documented atrial fibrillation lasting longer than 30 seconds (outside the 90 day blanking period) OR * Intervention for atrial fibrillation (except for repeat cryoablation during the 90 day blanking period)

Outcome measures

Outcome measures
Measure	Modified Intent to Treat Group (mITT) n=354 Participants Enrolled subjects that met all inclusion and no exclusion criteria, and who underwent a study cryoablation procedure.
Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years 1 year freedom from CTF	80.4 Percentage of participants Interval 75.9 to 84.2
Chronic Effectiveness: Percentage of Participants Free of Chronic Treatment Failure (CTF) at 1 and 2 Years 2 year freedom from CTF	72.8 Percentage of participants Interval 67.7 to 77.2

Adverse Events

Treated Group

Serious events: 145 serious events

Other events: 70 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Treated Group n=359 participants at risk Enrolled subjects who underwent a study cryoablation procedure whether or not they met all inclusion/exclusion criteria.
Cardiac disorders Atrial Fibrillation	18.1% 65/359 • Number of events 75 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Atrial Flutter	5.6% 20/359 • Number of events 20 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.2% 8/359 • Number of events 9 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Coronary Artery Disease	0.84% 3/359 • Number of events 5 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Urinary Tract Infection	1.4% 5/359 • Number of events 5 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Cardiac Failure Congestive	1.1% 4/359 • Number of events 4 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Meniscus Injury	1.1% 4/359 • Number of events 4 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Acute myocardial infarction	0.84% 3/359 • Number of events 3 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Phrenic Nerve Paralysis	0.84% 3/359 • Number of events 3 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Post procedural haemmorhage	0.84% 3/359 • Number of events 3 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Sinus node dysfunction	0.84% 3/359 • Number of events 3 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Blood and lymphatic system disorders Anaemia	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Angina Pectoris	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Angina unstable	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Atrial tachycardia	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Bradycardia	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Cerebrovascular accident	0.28% 1/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
General disorders Chest pain	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Hepatobiliary disorders Cholangitis	0.28% 1/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Diverticulitis	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Vascular disorders Haematoma	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Inguinal hernia	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Psychiatric disorders Mental status changes	0.28% 1/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Pancreatitis	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Pericardial effusion	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Pulmonary vein stenosis	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.56% 2/359 • Number of events 2 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
General disorders Accidental death	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Renal and urinary disorders Acute kidney injury	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Immune system disorders Allergy to arthropod sting	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Vascular disorders Aortic stenosis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Aortic valve stenosis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder adenocarcinoma stage unspecified	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Brain stem haemorrhage	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Bronchitis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Bronchitis viral	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Investigations CHA2DS2-VASc annual stroke risk moderate	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Renal and urinary disorders Calculus ureteric	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Cardiac failure	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Cardiomyopathy	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Carpal tunnel syndrome	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
General disorders Catheter site haemorrhage	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Cauda equina syndrome	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Cellulitis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Cerebral Haemmorhage	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Hepatobiliary disorders Cholecystitis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Cholecystitis infective	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Hepatobiliary disorders Cholelithiasis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Clostridium difficile colitis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Clostridium difficile infection	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Colitis microscopic	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Surgical and medical procedures Colostomy closure	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Constipation	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
General disorders Death	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Diverticular perforation	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Escherichia bacteraemia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Fall	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Forearm fracture	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Gastrointestinal haemmorhage	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Generalised tonic-clonic seizure	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Eye disorders Glaucoma	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Haemmorhage intracranial	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Hip fracture	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Immune system disorders Hypersensitivity	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Vascular disorders Hypotension	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Ileus	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Surgical and medical procedures Knee arthroplasty	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Blood and lymphatic system disorders Lymphadenopathy	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Migraine	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Mitral valve calcification	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Multiple sclerosis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Renal and urinary disorders Nephrolithiasis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Neuralgia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Nodal rhythym	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
General disorders Non-cardiac chest pain	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Metabolism and nutrition disorders Obesity	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Osteoporosis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Pericarditis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Periprosthetic fracture	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell leukaemia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Pneumonia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Pneumonia bacterial	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Hepatobiliary disorders Post procedural bile leak	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Procedural pain	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Psychiatric disorders Psychotic disorder	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Rectal haemmorhage	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Eye disorders Retinal detachment	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Sepsis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Small intestinal obstruction	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Spinal compression fracture	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Subdural haematoma	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Toxicity to various agents	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Nervous system disorders Transient global amnesia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Musculoskeletal and connective tissue disorders Trigger finger	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Gastrointestinal disorders Umbilical hernia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Infections and infestations Urosepsis	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Cardiac disorders Ventricular tachycardia	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.
Eye disorders Vitreous detachment	0.28% 1/359 • Number of events 1 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.

Other adverse events

Other adverse events
Measure	Treated Group n=359 participants at risk Enrolled subjects who underwent a study cryoablation procedure whether or not they met all inclusion/exclusion criteria.
Cardiac disorders Atrial fibrillation	19.5% 70/359 • Number of events 98 • All adverse events were collected between subject consent (enrollment) and study completion (3 years post study cryoablation procedure) or study exit.

Additional Information

Kirsten Rasmussen

Medtronic

Phone: 763-526-2833

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER