Trial Outcomes & Findings for Continued Access Protocol (NCT NCT00889681)

Last Updated: 2018-09-19

Results Overview

Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.

Recruitment status

COMPLETED

Study phase

Target enrollment

81 participants

Primary outcome timeframe

365 days

Results posted on

2018-09-19

Participant Flow

Investigators at ten (10) sites enrolled a total of 81 study subjects between March 31, 2009 and January 24, 2011. The first subject was cryoablated on April 3, 2009.

There were three (3) subjects who were early exits in the study, two for not meeting qualification criteria and one for insurance disapproval.

Participant milestones

Participant milestones
Measure	Enrolled for Cryoablation Treatment All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
Overall Study STARTED	81
Overall Study Received Treatment	78
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled for Cryoablation Treatment All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
Overall Study Not meeting qualification Criteria	2
Overall Study Insurance disapproval	1

Baseline Characteristics

Continued Access Protocol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled for Cryoablation Treatment n=81 Participants All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	58.7 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants
Region of Enrollment United States	81 participants n=5 Participants

PRIMARY outcome

Timeframe: 365 days

Population: 78 of the 81 enrolled subjects were treated with cryoablation.

Outcome measures

Outcome measures
Measure	Treated With Cryoablation n=78 Participants Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Cryoablation Procedure Events (CPEs) One or more CPE (all types)	1 Participants
Cryoablation Procedure Events (CPEs) CPE type: Access site complications	0 Participants
Cryoablation Procedure Events (CPEs) CPE type: Cardiac damage (including MI)	0 Participants
Cryoablation Procedure Events (CPEs) CPE type: Embolic phenomena (including stroke)	0 Participants
Cryoablation Procedure Events (CPEs) CPE type: Arrhythmias	1 Participants
Cryoablation Procedure Events (CPEs) CPE type: Persistent phrenic nerve injury	0 Participants
Cryoablation Procedure Events (CPEs) CPE type: Death	0 Participants
Cryoablation Procedure Events (CPEs) CPE type: Pulmonary vein stenosis	0 Participants

PRIMARY outcome

Timeframe: At the conclusion of the cryoablation procedure

Population: 78 of 81 subjects were treated with cryoablation.

Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.

Outcome measures

Outcome measures
Measure	Treated With Cryoablation n=78 Participants Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Acute Procedural Success (APS)	75 Participants

PRIMARY outcome

Timeframe: 365 days

Population: 78 of 81 enrolled subjects were treated with cryoablation.

Composite event including: cardiovascular death, hospitalization for: (AF recurrence or ablation, atrial flutter ablation (excluding Type I), systemic embolization (not stroke), congestive heart failure, hemorrhagic event (not stroke)), anti-arrhythmic drug: initiation, adjustment or complication, myocardial infarction, stroke.

Outcome measures

Outcome measures
Measure	Treated With Cryoablation n=78 Participants Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Freedom From Major Atrial Fibrillation Events (MAFE) Freedom from any MAFE (all types)	74 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) One or more MAFE (all types)	4 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Cardvascular death	0 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Hosp for AF recurrence or ablation	2 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Hosp for A flutter ablation (ex Type I)	0 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Hosp for systemic embolism (not stroke)	0 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Hosp for congestive heart failure	0 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Hosp for hemorrhagic event (not stroke)	2 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Antiarrhythmic medication	1 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Myocardial infarction	0 Participants
Freedom From Major Atrial Fibrillation Events (MAFE) MAFE type: Stroke	0 Participants

PRIMARY outcome

Timeframe: 180 days

Population: 78 of 81 subjects were treated with cryoablation.

Composite of both Acute Procedural Success and freedom from Chronic Treatment Failure. Freedom from Chronic Treatment Failure (CTF) was defined as no occurrence of an AF Intervention and no occurrence of Detectable AF which is defined as an episode of AF, documented in a tracing, and lasting more than 30 seconds, occurring during a Non Blanked Follow-up Period.

Outcome measures

Outcome measures
Measure	Treated With Cryoablation n=78 Participants Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
Long-term Clinical Success	51 Participants

Adverse Events

Treated With Cryoablation

Serious events: 12 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treated With Cryoablation n=78 participants at risk This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF ("Atrial Fibrillation Drugs " or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug. Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
Cardiac disorders Atrial Fibrillation	7.7% 6/78 • Number of events 8 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Surgical and medical procedures Drug Therapy	1.3% 1/78 • Number of events 2 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Cardiac disorders Atrial Flutter	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Surgical and medical procedures Bladder Repair	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Gastrointestinal disorders Bleeding Duodenal Ulcer	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Cardiac disorders Cardiac Tamponade	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Nervous system disorders Cerebrovascular Accident	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Cardiac disorders Dizziness	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Blood and lymphatic system disorders INR ratio increased	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Vascular disorders Migraine	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Reproductive system and breast disorders Orchitis	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Renal and urinary disorders Acute Renal Failure	1.3% 1/78 • Number of events 1 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.

Other adverse events

Other adverse events
Measure	Treated With Cryoablation n=78 participants at risk This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF ("Atrial Fibrillation Drugs " or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug. Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation.
General disorders CATHETER SITE HAEMATOMA	14.1% 11/78 • Number of events 16 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Cardiac disorders PALPITATIONS	10.3% 8/78 • Number of events 11 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Cardiac disorders ATRIAL FLUTTER	9.0% 7/78 • Number of events 9 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Cardiac disorders ATRIAL FIBRILLATION	9.0% 7/78 • Number of events 9 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
General disorders CATHETER SITE HAEMORRHAGE	9.0% 7/78 • Number of events 9 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Gastrointestinal disorders NAUSEA	9.0% 7/78 • Number of events 7 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.
Respiratory, thoracic and mediastinal disorders COUGH	7.7% 6/78 • Number of events 6 • From time of consent to study exit (mean follow up time 3.4 years) Serious Adverse Event: a) resulting in death, b) life-threatening, c) resulting in inpatient hospitalization \>48 hrs or prolongation of existing hospitalization by 2 or more days, d) resulting in persistent, significant, disability or incapacity, or e) resulting in a congenital anomaly or birth defect.

Additional Information

Dana Wigert- Sr. Clinical Research Specialist

Medtronic- AF Solutions

Phone: 763-526-2802

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place