Back to resultsNAVISTAR® THERMOCOOL® Catheter Post Approval Registry (AF Registry)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Atrial fibrillation ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation
Eligibility Criteria
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.
Sites / Locations
- Diagnostic Cardiology Associates PA
- Loyola University Medical Center
- Central Baptist Hospital
- University of Maryland
- Johns Hopkins Hospital
- Washington Adventist Hospital
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Henry Ford Hospital
- Park Nicollet Institute
- St. Luke's Roosevelt Hospital
- University of Rochester Medical Center
- Duke University Medical Center
- Cleveland Clinic Foundation
- Ohio State University
- University of Oklahoma
- Hospital of the University of Pennsylvania
- Texas Cardiac Arrhythmia Research Foundation
- Austin Heart PA
- Inova Fairfax Hospital
- Virginia Commonwealth University
- St. Luke's Medical Center
- Montreal Heart Institute (Institut de Cardiologie de Montreal)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
More-Experienced Physicians (MEP)
Less-Experienced Physicians (LEP)
Arm Description
Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.
Physicians who perform less than 50 atrial fibrillation ablation procedures per year.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT00964392
First Posted
August 20, 2009
Last Updated
September 18, 2018
Sponsor
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00964392
Brief Title
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
Acronym
AF Registry
Official Title
NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation - Post Approval Registry
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2009 (Actual)
Primary Completion Date
September 1, 2013 (Actual)
Study Completion Date
January 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
437 (Actual)
8. Arms, Groups, and Interventions
Arm Title
More-Experienced Physicians (MEP)
Arm Type
Experimental
Arm Description
Physicians who perform greater than or equal to 50 atrial fibrillation ablation procedures per year.
Arm Title
Less-Experienced Physicians (LEP)
Arm Type
Experimental
Arm Description
Physicians who perform less than 50 atrial fibrillation ablation procedures per year.
Intervention Type
Procedure
Intervention Name(s)
Atrial fibrillation ablation
Intervention Description
Radiofrequency ablation
Primary Outcome Measure Information:
Title
The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.
Description
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.
Time Frame
Seven days post ablation procedure
Secondary Outcome Measure Information:
Title
Percentage of Subjects Experienced Serious Adverse Events.
Description
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).
Time Frame
First study day to 5 year post-ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Diagnostic Cardiology Associates PA
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington Adventist Hospital
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20903
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Park Nicollet Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
St. Luke's Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Heart PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Inova Fairfax Hospital
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Montreal Heart Institute (Institut de Cardiologie de Montreal)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
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