Trial Review

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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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01687166