Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)
This study is currently recruiting participants.
Verified May 2013 by Boston Scientific Corporation
Sponsor:
Boston Scientific Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01687166
First received: August 29, 2012
Last updated: May 15, 2013
Last verified: May 2013
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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 |
|---|---|
|
Paroxysmal Atrial Fibrillation (PAF) |
Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific) Device: FDA Approved Open-Irrigated Ablation Catheter |
| 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:
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: | 472 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687166
Contacts
| Contact: Bryan Wylie | (408) 935-6166 | bryan.wylie@bsci.com |
| Contact: Lynnett Voshage-Stahl | 651-582-2994 | Lynnett.Voshage-Stahl@bsci.com |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Rosemary Bubien, RN rbubien@cardiology.uab.edu | |
| Principal Investigator: Tom McElderry, MD | |
| Sub-Investigator: Jose Osorio, MD | |
| United States, California | |
| University of California at San Francisco | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: James Jameze jjames@medicine.ucsf.edu | |
| Principal Investigator: Nitish Badhwar, MD | |
| United States, Georgia | |
| Emory University Hospital | Not yet recruiting |
| Atlanta, Georgia, United States, 30308 | |
| Contact: Paige Smith pfsmith@emory.edu | |
| Principal Investigator: David B DeLurgio, MD | |
| Sub-Investigator: Mikhael El-Chami, MD | |
| United States, Michigan | |
| William Beaumont Hospital | Not yet recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Patti Naismith 248-898-8141 pnaismith@beaumont.edu | |
| Principal Investigator: David Haines, MD | |
| Sub-Investigator: Ilana Kutinsky, MD | |
| United States, New York | |
| New York University | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Laura Kuznekoff 212-263-7704 Laura.Kuznekoff@nuymc.org | |
| Principal Investigator: Larry Chinitz, MD | |
| Sub-Investigator: Anthony Aizer, MD | |
| Strong Memorial Hospital of the University of Rochester | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Laura Wing, RN laura_wing@urmc.rochester.edu | |
| Sub-Investigator: David Huang, MD | |
| Principal Investigator: Burr Hall, MD | |
| United States, Ohio | |
| Akron General Medical Center | Not yet recruiting |
| Akron, Ohio, United States, 43214 | |
| Contact: Debbie Rovniak Deborah.Rovniak@akrongeneral.org | |
| Principal Investigator: Robert Schweikert, MD | |
| Sub-Investigator: Sergio Vitebskiy, MD | |
| Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Julie Ryan, RN julie.ryan@osumc.edu | |
| Principal Investigator: John Hummel, MD | |
| Sub-Investigator: Steven Kalbfleish, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Not yet recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Debbie Adams, RN adamsde@musc.edu | |
| Principal Investigator: Frank Cuoco, MD | |
| Sub-Investigator: J.Lacy Sturdivant, MD | |
| United States, Texas | |
| Texas Cardiac Arrhythmia Research Foundation | Recruiting |
| Austin, Texas, United States, 78705 | |
| Contact: Deb Cardinal dscardinal@austinheartbeat.com | |
| Principal Investigator: David Burkhardt, MD | |
| Sub-Investigator: Shane Bailey, MD | |
| Sub-Investigator: G J Gallinghouse, MD | |
| EP Heart / Memorial Hermann Texas Medical Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Rusty Roussel rroussel@epheart.com | |
| Principal Investigator: Ramesh Hariharan, MD | |
| Sub-Investigator: Saumya Sharma, MD | |
| United States, Virginia | |
| University of Virginia | Not yet recruiting |
| Charlotesville, Virginia, United States, 22908 | |
| Contact: Mary Jane Strickland Mjs7w@virginia.edu | |
| Principal Investigator: J. Michael Mangrum, MD | |
| Sub-Investigator: John D Ferguson, MD | |
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
No publications provided
| 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: | May 15, 2013 |
| 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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013