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

Paroxysmal Atrial Fibrillation (PAF) Clinical Trial

— ZERO-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687166
• Other study ID #: CDM00048665
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation (PAF)

Intervention

Device:
• Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

• FDA Approved Open-Irrigated Ablation Catheter

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Heart Care Partners	Brisbane	Queensland
Czechia	Na Homolce Hospital	Prague
France	CHU of Bordeaux	Pessac	Gironde
Germany	Charité University Berlin	Berlin
Germany	Staedtisches Klinikum Karlsruhe	Karlsruhe
Portugal	Centro Hospital de Santa Cruz	Carnaxide
Spain	Hospital Clinico Y Provincial	Barcelona
Spain	Clínica Universitaria de Navarra	Pamplona
Sweden	Karolinska University Hospital	Stockholm
United Kingdom	Golden Jubilee National Hospital	Glasgow
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Union Memorial Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University Medical Center	Columbus	Ohio
United States	University of Texas Health Science Center	Houston	Texas
United States	Hunstville Hospital	Huntsville	Alabama
United States	St. Vincent's Medical Center	Jacksonville	Florida
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Mt. Sinai Medical Center	New York	New York
United States	New York University	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Baptist Hospital	Pensacola	Florida
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Sequoia Hospital	Redwood City	California
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California, San Francisco	San Francisco	California
United States	Tampa General Hospital	Tampa	Florida
United States	Trinity Mother of Frances Health System	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-related Complication Free Rate	The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.; The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (=70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.	12 Months
Primary	Chronic Success Rate	The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.; *failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.	Within 12 months of the index procedure
Secondary	Acute Success	Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.	Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation