Atrial Fibrillation
Conditions
Brief summary
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is under review. This study will also allow collection of additional safety data following modifications implemented into the Arctic Front® Catheter and Cryoablation System.
Detailed description
1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects free from one or more primary safety outcome measures-Cryoablation Procedure Events (CPEs) and Major Atrial Fibrillation Events (MAFEs), in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). 2. To evaluate the effectiveness of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of subjects with success in the primary effectiveness outcome measure of Long Term Clinical Success (LTCS) in adult patients with paroxysmal atrial fibrillation who have failed one or more Atrial Fibrillation Drugs (AFDs). 3. To evaluate the acute performance of the modified Arctic Front® Cardiac CryoAblation Catheter System for comparison with the Arctic Front® Cardiac CryoAblation Catheter System used in the PS-023 STOP AF Pivotal Trial.
Interventions
DEVICEArctic 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.
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Subjects must fulfill ALL of the following criteria: 1. Documented PAF: * diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND * 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing 2. 18 and 75 years of age 3. Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.
Exclusion criteria
ANY of the following is regarded as a criterion for excluding a subject from the study: 1. Any previous left atrial (LA) ablation (except permissible retreatment subjects) 2. Any previous LA surgery 3. Current intracardiac thrombus (can be treated after thrombus is resolved) 4. Presence of any pulmonary vein stents 5. Presence of any pre-existing pulmonary vein stenosis 6. Pre-existing hemidiaphragmatic paralysis 7. Anteroposterior LA diameter \> 5.5 cm by TTE 8. Presence of any cardiac valve prosthesis 9. Clinically significant mitral valve regurgitation or stenosis 10. Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date 11. Unstable angina 12. Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date 13. Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO) 14. NYHA class III or IV congestive heart failure 15. Left ventricular ejection fraction (LVEF) \< 40% 16. 2º (Type II) or 3º atrioventricular block 17. Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 18. Brugada syndrome 19. Long QT syndrome 20. Arrhythmogenic right ventricular dysplasia 21. Sarcoidosis 22. Hypertrophic cardiomyopathy 23. Known cryoglobulinemia 24. Uncontrolled hyperthyroidism 25. Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date. 26. Any woman known to be pregnant 27. Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions: * negative β-HCG test within 7 days prior to Start Date * history of surgical sterilization * postmenopausal and free of menses for at least 12 months. 28. Life expectancy less than one (1) year 29. Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study 30. Unwilling or unable to comply fully with study procedures and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cryoablation Procedure Events (CPEs) | 365 days | Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis. |
| Acute Procedural Success (APS) | At the conclusion of the cryoablation procedure | Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure. |
| Freedom From Major Atrial Fibrillation Events (MAFE) | 365 days | 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. |
| Long-term Clinical Success | 180 days | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
There were three (3) subjects who were early exits in the study, two for not meeting qualification criteria and one for insurance disapproval.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled for Cryoablation Treatment All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation. | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insurance disapproval | 1 |
| Overall Study | Not meeting qualification Criteria | 2 |
Baseline characteristics
| Characteristic | Enrolled for Cryoablation Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 25 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Age, Continuous | 58.7 years STANDARD_DEVIATION 10.4 |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 33 / 78 |
| serious Total, serious adverse events | 12 / 78 |
Outcome results
Primary
Acute Procedural Success (APS)
Demonstration of electrical isolation in ≥ 3 pulmonary veins or their anomalous equivalents at the conclusion of the first protocol-defined cryoablation procedure.
Time frame: At the conclusion of the cryoablation procedure
Population: 78 of 81 subjects were treated with cryoablation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Cryoablation | Acute Procedural Success (APS) | 75 Participants |
Primary
Cryoablation Procedure Events (CPEs)
Composite event: access site complications, cardiac damage (including myocardial infarction), embolic phenomena (including stroke), arrhythmia, persistent phrenic nerve injury, death and pulmonary vein stenosis.
Time frame: 365 days
Population: 78 of the 81 enrolled subjects were treated with cryoablation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Cardiac damage (including MI) | 0 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Embolic phenomena (including stroke) | 0 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | One or more CPE (all types) | 1 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Access site complications | 0 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Arrhythmias | 1 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Persistent phrenic nerve injury | 0 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Death | 0 Participants |
| Treated With Cryoablation | Cryoablation Procedure Events (CPEs) | CPE type: Pulmonary vein stenosis | 0 Participants |
Primary
Freedom From Major Atrial Fibrillation Events (MAFE)
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.
Time frame: 365 days
Population: 78 of 81 enrolled subjects were treated with cryoablation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Stroke | 0 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | Freedom from any MAFE (all types) | 74 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | One or more MAFE (all types) | 4 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Cardvascular death | 0 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Hosp for AF recurrence or ablation | 2 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Hosp for A flutter ablation (ex Type I) | 0 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Hosp for systemic embolism (not stroke) | 0 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Hosp for congestive heart failure | 0 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Hosp for hemorrhagic event (not stroke) | 2 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Antiarrhythmic medication | 1 Participants |
| Treated With Cryoablation | Freedom From Major Atrial Fibrillation Events (MAFE) | MAFE type: Myocardial infarction | 0 Participants |
Primary
Long-term Clinical Success
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.
Time frame: 180 days
Population: 78 of 81 subjects were treated with cryoablation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treated With Cryoablation | Long-term Clinical Success | 51 Participants |