Paroxysmal Atrial Fibrillation (PAF)ZERO-AFNCT01687166
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
A study testing Blazer Open-Irrigated Ablation Catheter (Boston Scientific) and FDA Approved Open-Irrigated Ablation Catheter in people with Paroxysmal Atrial Fibrillation (PAF), run by Boston Scientific Corporation at 38 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF)
- What is being tested?
- Blazer Open-Irrigated Ablation Catheter (Boston Scientific) and FDA Approved Open-Irrigated Ablation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 38 sitesin 9 countries
- Study dates
- Oct 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 22Show fewer
- 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
Trial locations and contacts
38 sites in 9 countries.
38 sites in 9 countries
United States27 sites
University of Michigan
Ann Arbor, Michigan, 48109-5853
Emory University Hospital
Atlanta, Georgia, 30308
Georgia Health Sciences University
Augusta, Georgia, 30912
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Union Memorial Hospital
Baltimore, Maryland, 21229
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908
Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas Health Science Center
Houston, Texas, 77030
Hunstville Hospital
Huntsville, Alabama, 35801
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Yale University
New Haven, Connecticut, 06520
New York University
New York, New York, 10016
Mt. Sinai Medical Center
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Baptist Hospital
Pensacola, Florida, 32501
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sequoia Hospital
Redwood City, California, 94062
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California, San Francisco
San Francisco, California, 94143
Tampa General Hospital
Tampa, Florida, 33606
Trinity Mother of Frances Health System
Tyler, Texas, 75701
Australia2 sites
Royal Adelaide Hospital
Adelaide, South Australia, SA 5000
Heart Care Partners
Brisbane, Queensland, QL 4120 QLD
Germany2 sites
Charité University Berlin
Berlin, 13353
Staedtisches Klinikum Karlsruhe
Karlsruhe, 76133
Spain2 sites
Hospital Clinico Y Provincial
Barcelona, 8036
Clínica Universitaria de Navarra
Pamplona, 31008
About this study
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.
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Being tested
- Blazer Open-Irrigated Ablation Catheter (Boston Scientific), FDA Approved Open-Irrigated Ablation Catheter
- Keywords
- Paroxysmal Atrial Fibrillation, Cardiac Arrhythmias, Heart Disease, Cardiovascular Disease, Radiofrequency Ablation
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)Device
FDA Approved Open-Irrigated Ablation CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Blazer Open-Irrigated Ablation Catheter | Experimental | Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system Receives: Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific) |
| FDA Approved Open-Irrigated Ablation Catheter | Active comparator | FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. Receives: Device: FDA Approved Open-Irrigated Ablation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure-related Complication Free Rate
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.
Measured: 12 Months
Chronic Success Rate
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.
Measured: Within 12 months of the index procedure
Secondary outcomes (1)
Acute Success
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.
Measured: Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Natale, M.D., Principal investigator, Texas Cardiac Arrhythmia Institute at St. David's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687166
- Sponsor's protocol ID
- CDM00048665
- Acronym
- ZERO-AF
- Status last verified
- Oct 2018
- First submitted
- 29 Aug 2012
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01687166
- Acronym / sponsor ID
- ZERO-AF / CDM00048665
- Conditions
- Paroxysmal Atrial Fibrillation (PAF)
- Keywords
- Paroxysmal Atrial Fibrillation, Cardiac Arrhythmias, Heart Disease, Cardiovascular Disease, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Posted 18 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blazer Open-Irrigated Ablation Catheter | Experimental | Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system |
| FDA Approved Open-Irrigated Ablation Catheter | Active comparator | Device: FDA Approved Open-Irrigated Ablation CatheterFDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- Have any of the following heart conditions within 90 days prior to enrollment:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blazer Open-Irrigated Ablation Catheter (Boston Scientific) | Device | Blazer Open-Irrigated Ablation Catheter |
| FDA Approved Open-Irrigated Ablation Catheter | Device | FDA Approved Open-Irrigated Ablation Catheter |
Primary outcome
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.
1 secondary outcome
Acute Success
Time frame: Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natale, M.D. principal investigator
Texas Cardiac Arrhythmia Institute at St. David's Medical Center
38 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blazer Open-Irrigated Ablation Catheter (Boston Scientific) and FDA Approved Open-Irrigated Ablation Catheter in people with Paroxysmal Atrial Fibrillation (PAF), run by Boston Scientific Corporation at 38 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Australia, Germany, Spain, Czechia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related Complication Free Rate (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.