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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01687166




Registration number
NCT01687166
Ethics application status
Date submitted
29/08/2012
Date registered
18/09/2012
Date last updated
21/11/2018

Titles & IDs
Public title
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Scientific title
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Secondary ID [1] 0 0
CDM00048665
Universal Trial Number (UTN)
Trial acronym
ZERO-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paroxysmal Atrial Fibrillation (PAF) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Blazer Open-Irrigated Ablation Catheter - Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Procedure-related Complication Free Rate
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
Chronic Success Rate
Timepoint [2] 0 0
Within 12 months of the index procedure
Secondary outcome [1] 0 0
Acute Success
Timepoint [1] 0 0
Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2016
Sample size
Target
Accrual to date
Final
398
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Heart Care Partners - Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
QL 4120 QLD - Brisbane
Recruitment postcode(s) [2] 0 0
SA 5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
Czechia
State/province [17] 0 0
Prague
Country [18] 0 0
France
State/province [18] 0 0
Gironde
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Karlsruhe
Country [21] 0 0
Portugal
State/province [21] 0 0
Carnaxide
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Spain
State/province [23] 0 0
Pamplona
Country [24] 0 0
Sweden
State/province [24] 0 0
Stockholm
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01687166
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrea Natale, M.D.
Address 0 0
Texas Cardiac Arrhythmia Institute at St. David's Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01687166