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

NCT ID: NCT01687166

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 398 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-10-31

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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Blazer Open-Irrigated Ablation Catheter

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

Group Type: EXPERIMENTAL

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

Intervention Type: DEVICE

FDA Approved Open-Irrigated Ablation Catheter

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

Group Type: ACTIVE_COMPARATOR

FDA Approved Open-Irrigated Ablation Catheter

Intervention Type: DEVICE

Interventions

Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

Intervention Type: DEVICE

FDA Approved Open-Irrigated Ablation Catheter

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Natale, M.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Locations

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

University of Virginia

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Heart Care Partners

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Na Homolce Hospital

Prague, , Czechia

CHU of Bordeaux

Pessac, Gironde, France

Charité University Berlin

Berlin, , Germany

Staedtisches Klinikum Karlsruhe

Karlsruhe, , Germany

Centro Hospital de Santa Cruz

Carnaxide, , Portugal

Hospital Clinico Y Provincial

Barcelona, , Spain

Clínica Universitaria de Navarra

Pamplona, , Spain

Karolinska University Hospital

Stockholm, , Sweden

Golden Jubilee National Hospital

Glasgow, , United Kingdom

Countries

United States; Australia; Czechia; France; Germany; Portugal; Spain; Sweden; United Kingdom

Other Identifiers

CDM00048665

Identifier Type: -

Identifier Source: org_study_id