Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)

Boston Scientific

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Treatments: Device: FDA Approved Open-Irrigated Ablation Catheter; Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01687166

CDM00048665

Details and patient eligibility

About

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.

Full 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.

Enrollment: 398 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

398 participants in 2 patient groups

Blazer Open-Irrigated Ablation Catheter

Experimental group

Description:

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

Treatment:

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

FDA Approved Open-Irrigated Ablation Catheter

Active Comparator group

Description:

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

Treatment:

Device: FDA Approved Open-Irrigated Ablation Catheter