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

Purpose

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.

Condition	Intervention	Phase
Paroxysmal Atrial Fibrillation (PAF)	Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific) Device: FDA Approved Open-Irrigated Ablation Catheter	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Genetic and Rare Diseases Information Center resources: Familial Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Procedure-related complication free rate [ Time Frame: 7-days post-index procedure ] [ Designated as safety issue: Yes ]
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
Procedure-related complication free rate (continued) [ Time Frame: Within 12 months of the index procedure ] [ Designated as safety issue: Yes ]
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.
Chronic success rate [ Time Frame: Within 12 months of the index procedure ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Acute Success [ Time Frame: 20 minutes after the last radiofrequency application to isolate the pulmonary vein ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	552
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	November 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Blazer Open-Irrigated Ablation Catheter Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system	Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
Active Comparator: 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.	Device: FDA Approved Open-Irrigated Ablation Catheter

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687166

Show 38 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators


Principal Investigator:	Andrea Natale, M.D.	Texas Cardiac Arrhythmia Institute at St. David's Medical Center

More Information


Responsible Party:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT01687166 History of Changes
Other Study ID Numbers:	CDM00048665
Study First Received:	August 29, 2012
Last Updated:	March 3, 2016
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:


Paroxysmal Atrial Fibrillation Cardiac Arrhythmias Heart Disease Cardiovascular Disease Radiofrequency Ablation

Additional relevant MeSH terms:


Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases	Pathologic Processes Acifluorfen Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016

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