Overview

This trial is active, not recruiting.

Condition paroxysmal atrial fibrillation (paf)
Treatments blazer open-irrigated ablation catheter (boston scientific), fda approved open-irrigated ablation catheter
Phase phase 3
Sponsor Boston Scientific Corporation
Start date October 2012
End date November 2016
Trial size 552 participants
Trial identifier NCT01687166, CDM00048665

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
blazer open-irrigated ablation catheter (boston scientific)
(Active Comparator)
FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.
fda approved open-irrigated ablation catheter

Primary Outcomes

Measure
Procedure-related complication free rate
time frame: 7-days post-index procedure
Procedure-related complication free rate (continued)
time frame: Within 12 months of the index procedure
Chronic success rate
time frame: Within 12 months of the index procedure

Secondary Outcomes

Measure
Acute Success
time frame: 20 minutes after the last radiofrequency application to isolate the pulmonary vein

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Principal investigator Andrea Natale, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.