Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation (PAF)

In brief

The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

Key facts

Study ID

NCT01687166

Run by

Boston Scientific Corporation

People needed

398

Starts

2012-10-01

Expected to finish

2016-10-01

Last updated by the study team

2018-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Hunstville Hospital — Huntsville, Alabama, United States
• Sequoia Hospital — Redwood City, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• St. Vincent's Medical Center — Jacksonville, Florida, United States
• Baptist Hospital — Pensacola, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Georgia Health Sciences University — Augusta, Georgia, United States
• Union Memorial Hospital — Baltimore, Maryland, United States
• Caritas St. Elizabeth's Medical Center — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• New York University — New York, New York, United States
• Mt. Sinai Medical Center — New York, New York, United States
• Strong Memorial Hospital of the University of Rochester — Rochester, New York, United States
• University of North Carolina Medical Center — Chapel Hill, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States
• Trinity Mother of Frances Health System — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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