Continued Access Protocol

NCT00889681 | Completed Results DMC

• 1 other identifier: CAP PS-024
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 10

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  180 days

Study Arms (1)

Ablation

EXPERIMENTAL

All study subjects will be receive cryo ablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.

Device: Arctic Front Cardiac Cryoablation System

Interventions

Arctic Front Cardiac Cryoablation System DEVICE

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.

Also known as: Arctic Front® Catheter Ref# 2AF232 & 2AF282, Manual Retraction Kit Ref# 20MRK, Freezor MAX Catheter Ref # 239F3 & 239F5, Console Ref # 106A2

Ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must fulfill ALL of the following criteria:
• Documented PAF:
• diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
• or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
• and 75 years of age
• 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.

You may not qualify if:

• ANY of the following is regarded as a criterion for excluding a subject from the study:
• Any previous left atrial (LA) ablation (except permissible retreatment subjects)
• Any previous LA surgery
• Current intracardiac thrombus (can be treated after thrombus is resolved)
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Anteroposterior LA diameter \> 5.5 cm by TTE
• Presence of any cardiac valve prosthesis
• Clinically significant mitral valve regurgitation or stenosis
• Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
• Unstable angina
• Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
• Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
• NYHA class III or IV congestive heart failure

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead
• Medtronic: collaborator

Study Sites (10)

Banner Good Samaritan

Phoenix, Arizona, 85006, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford Hospital & Clinical

Stanford, California, 94305-5288, United States

Location

Bay Heart Group

Tampa, Florida, 33607, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

Inova Research Center

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dana Wigert- Sr. Clinical Research Specialist
• Organization: Medtronic- AF Solutions

dana.wigert@medtronic.com

763-526-2802

Study Officials

• Douglas Packer, MD

  Mayo Clinic, Rochester, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2009
• First Posted: April 29, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 19, 2018
• Results First Posted: April 25, 2014

Record last verified: 2018-09

Locations

US (10)