Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01687166 |
|
Recruitment Status :
Completed
First Posted : September 18, 2012
Results First Posted : June 18, 2018
Last Update Posted : November 21, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Paroxysmal Atrial Fibrillation (PAF) | Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific) Device: FDA Approved Open-Irrigated Ablation Catheter | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 398 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation |
| Study Start Date : | October 2012 |
| Actual Primary Completion Date : | October 2016 |
| Actual Study Completion Date : | October 2016 |
| Arm | Intervention/treatment |
|---|---|
|
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 |
- Procedure-related Complication Free Rate [ Time Frame: 12 Months ]
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.
- Chronic Success Rate [ Time Frame: Within 12 months of the index procedure ]
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.
- Acute Success [ Time Frame: Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation ]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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687166
Show 38 study locations
| Principal Investigator: | Andrea Natale, M.D. | Texas Cardiac Arrhythmia Institute at St. David's Medical Center |
| Responsible Party: | Boston Scientific Corporation |
| ClinicalTrials.gov Identifier: | NCT01687166 |
| Other Study ID Numbers: |
CDM00048665 |
| First Posted: | September 18, 2012 Key Record Dates |
| Results First Posted: | June 18, 2018 |
| Last Update Posted: | November 21, 2018 |
| Last Verified: | October 2018 |
|
Paroxysmal Atrial Fibrillation Cardiac Arrhythmias Heart Disease Cardiovascular Disease Radiofrequency Ablation |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Acifluorfen Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |