Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)
Paroxysmal Atrial Fibrillation (PAF)
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation (PAF) focused on measuring Paroxysmal Atrial Fibrillation, Cardiac Arrhythmias, Heart Disease, Cardiovascular Disease, Radiofrequency Ablation
Eligibility Criteria
Inclusion Criteria:
History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days prior to enrollment
o PAF is AF episodes that last ≥30 seconds in duration and terminate within 7 days.
- At least 1 episode of PAF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG in the 365 days prior to enrollment
- Refractory to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD)
- Age 18 or above, or of legal age to give informed consent specific to state and national law
- Competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation
Exclusion Criteria:
Have any of the following heart conditions within 90 days prior to enrollment:
- New York Heart Association (NYHA) Class III or IV
- Left ventricular ejection fraction (LVEF) <35%
- Left atrial (LA) diameter >5.5 cm
- Unstable angina or ongoing myocardial ischemia
- Transmural myocardial infarction (MI)
- Congenital structural heart disease that increases the risk of ablation or precludes catheter placement
- Undergone any left atrial catheter or surgical ablation
- Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment
- Had >1 AF episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year
- Subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment
- Contraindication to anticoagulation therapy
- Creatinine >2.5mg/dl or creatinine clearance <30mL/min within 90 days (3 months) prior to enrollment
- Prosthetic mitral or tricuspid heart valves
- Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment
- Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment
- History of CVA, TIA or PE within 180 days (6 months) prior to enrollment
- Left atrial appendage closure device
- Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD)
- Enrolled in any concurrent clinical trial without documented pre-approval from BSC
- Women who are pregnant or plan to become pregnant within the course of their participation in the investigation
- Life expectancy ≤ 2 years (730 days) per physician opinion
Sites / Locations
- University of Alabama at Birmingham
- Hunstville Hospital
- Sequoia Hospital
- University of California, San Francisco
- Yale University
- St. Vincent's Medical Center
- Baptist Hospital
- Tampa General Hospital
- Emory University Hospital
- Georgia Health Sciences University
- Union Memorial Hospital
- Caritas St. Elizabeth's Medical Center
- University of Michigan
- William Beaumont Hospital
- Jersey Shore University Medical Center
- New York University
- Mt. Sinai Medical Center
- Strong Memorial Hospital of the University of Rochester
- University of North Carolina Medical Center
- Ohio State University Medical Center
- Hospital of the University of Pennsylvania
- Medical University of South Carolina
- Texas Cardiac Arrhythmia Research Foundation
- University of Texas Health Science Center
- Trinity Mother of Frances Health System
- University of Virginia
- Sentara Norfolk General Hospital
- Heart Care Partners
- Royal Adelaide Hospital
- Na Homolce Hospital
- CHU of Bordeaux
- Charité University Berlin
- Staedtisches Klinikum Karlsruhe
- Centro Hospital de Santa Cruz
- Hospital Clinico Y Provincial
- Clínica Universitaria de Navarra
- Karolinska University Hospital
- Golden Jubilee National Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Blazer Open-Irrigated Ablation Catheter
FDA Approved Open-Irrigated Ablation Catheter
Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.