Clinical trial NCT01687166: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Official title: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation (PAF)
Keywords: Paroxysmal Atrial Fibrillation
Cardiac Arrhythmias
Heart Disease
Cardiovascular Disease
Radiofrequency Ablation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The ZERO-AF trial is a prospective, multicenter, single blind, 1:1 randomized study. The trial is designed to demonstrate that the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter are non-inferior to the safety and effectiveness of the control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. The control catheters are open-irrigated radiofrequency ablation catheters that are approved in the United States for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.

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

Primary outcomes:
measure: Procedure-related Complication Free Rate
timeFrame: 12 Months
measure: Chronic Success Rate
timeFrame: Within 12 months of the index procedure
Secondary outcomes:
measure: Acute Success
timeFrame: Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Hunstville Hospital
state: Alabama
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Mt. Sinai Medical Center
state: New York
city: Rochester
country: United States
facility: Strong Memorial Hospital of the University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Tyler
country: United States
facility: Trinity Mother of Frances Health System
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Brisbane
country: Australia
facility: Heart Care Partners
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Prague
country: Czechia
facility: Na Homolce Hospital
city: Pessac
country: France
facility: CHU of Bordeaux
state: Gironde
city: Berlin
country: Germany
facility: Charité University Berlin
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe
city: Carnaxide
country: Portugal
facility: Centro Hospital de Santa Cruz
city: Barcelona
country: Spain
facility: Hospital Clinico Y Provincial
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center
name: Andrea Natale, M.D.
role: PRINCIPAL_INVESTIGATOR
References: