NAVISTAR® THERMOCOOL® Catheter Post Approval Registry

Paroxysmal Atrial Fibrillation Clinical Trial

— AF Registry  

Official title:

NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964392
• Other study ID #: PMA #P030031/S014
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2009
• Est. completion date: January 5, 2018

Study information

• Verified date: September 2018
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).

Description:

This registry is a prospective, multi-center, non-randomized post approval evaluation comprised of two (2) registry arms with independent hypotheses. The registry arms are defined as; Arm 1) physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year and Arm 2) physicians who perform less than 50 atrial fibrillation ablation procedures per year. Subjects with drug refractory recurrent symptomatic PAF will be considered for this post approval registry. This registry will be conducted at up to 40 centers in a minimum of 381 evaluable subjects. The devices are currently FDA approved for commercial distribution under PMA #P030031/S11.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 437
• Est. completion date: January 5, 2018
• Est. primary completion date: September 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Candidates for this registry must meet ALL of the following criteria:

• Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.

• Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.

• Age 18 years or older.

• Able and willing to comply with all pre-, post- and follow-up testing and requirements.

• Signed Patient Informed Consent Form.

Exclusion Criteria:

Candidates will be excluded from the registry if any of the following conditions apply:

• Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

• AF episodes that last longer than 30 days and are terminated via cardioversion.

• CABG procedure within the last six (6) months.

• Awaiting cardiac transplantation or other cardiac surgery.

• Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).

• History of a documented thromboembolic event within the past one (1) year.

• Diagnosed atrial myxoma.

• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.

• Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).

• Acute illness or active systemic infection or sepsis.

• Unstable angina.

• Uncontrolled heart failure.

• Myocardial infarction within the previous two (2) months.

• History of blood clotting or bleeding abnormalities.

• Contraindication to anticoagulation (i.e. heparin or warfarin).

• Life expectancy less than 12 months.

• Enrollment in an investigational study evaluating another device or drug.

• Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Atrial fibrillation ablation
Radiofrequency ablation

Locations

Country	Name	City	State
Canada	Montreal Heart Institute (Institut de Cardiologie de Montreal)	Montreal	Quebec
United States	Austin Heart PA	Austin	Texas
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Fairfax	Virginia
United States	Diagnostic Cardiology Associates PA	Jacksonville	Florida
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Park Nicollet Institute	Minneapolis	Minnesota
United States	St. Luke's Roosevelt Hospital	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Washington Adventist Hospital	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.	The primary adverse events (AE) include Death, Myocardial infarction (MI), Pulmonary vein (PV) stenosis, Diaphragmatic paralysis, Atrio-esophageal fistula, Transient ischemic attack (TIA), Stroke/Cerebrovascular accident (CVA), Thromboembolism, Pericarditis, Cardiac tamponade, Pericardial effusion, Pneumothorax, Atrial perforation, Vascular access complications, Pulmonary edema, Hospitalization (including initial and prolonged, excluding those hospitalizations solely due to pre-existing arrhythmia recurrence), Heart block. Pulmonary vein stenosis (defined as =70% diameter reduction) and atrio-esophageal fistula occurring more than 7 days post-procedure shall be deemed a Primary AE. The primary endpoint for the Post-Approval Registry is a comparison of the 7-day primary AE rate against a performance criterion of 16 %. The 16% performance criterion is based on literature data and discussion with the FDA per IDE G030236.	Seven days post ablation procedure
Secondary	Percentage of Subjects Experienced Serious Adverse Events.	The occurrence of serious adverse events (SAE) was used to provide the prospective long-term safety data. The SAEs are summarized by the following time periods: 0 to 30 days post-ablation, 31 days to 365 post-ablation, 366 to 730 days post-ablation, and more than 730 days post-ablation. One subject might have experienced SAEs in more than one time periods. This report covers the SAEs occurred from September 29, 2009 (first patient enrolled) to June 23, 2015 (data download date for this report).	First study day to 5 year post-ablation