Continued Access Protocol

Medtronic Cardiac Rhythm and Heart Failure81 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Arctic Front Cardiac Cryoablation SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (10)

Banner Good Samaritan

Phoenix, Arizona, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Stanford Hospital & Clinical

Stanford, California, United States

Outcomes

Primary Outcomes

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

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

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

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

Data from ClinicalTrials.gov

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