Atrial FlutterBLOCk-CTINCT01253200

Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter

A study testing Blazer® Open-Irrigated Ablation Catheter in people with Atrial Flutter, run by Boston Scientific Corporation at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Flutter
What is being tested?: Blazer® Open-Irrigated Ablation Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 302 participants
Where: 26 sitesUnited States
Study dates: Jan 2011to Jan 2014
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

At least 1 documented episode of type 1 atrial flutter in the 180 days (6 months) preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or transtelephonic monitor
Patients are clinically indicated for catheter ablation
Patients receiving oral anti-arrhythmic drug therapy (class I or class III) for a tachyarrhythmia other than type 1 atrial flutter must be controlled on the anti-arrhythmic drug for a minimum of 30 days prior to enrollment. If type 1 atrial flutter was documented prior to the development of other tachyarrhythmias, this 30-day period is not required.
Age 18 or above, or of legal age to give informed consent specific to state and national law
Patients are 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

Any prior right atrial cavo-tricuspid isthmus ablation or any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment
Cardiac surgery within 90 days prior to enrollment
Myocardial infarction within 60 days prior to enrollment
Current unstable angina
Patients who cannot have anti-arrhythmic drugs (class I and class III) prescribed for the treatment of type 1 atrial flutter stopped on the day of the procedure
Patients regularly prescribed amiodarone within the 120 days (4 months) prior to enrollment

Show all 20Show fewer

Documented atrial or ventricular tumors, clots, thrombus, or have a known clotting disorder within 90 days prior to enrollment
Implantation of permanent leads of an implantable device in or through the right atrium within 90 days prior to enrollment
Direct remedial cause of atrial flutter (e.g. thyroid disease, pericarditis, pulmonary embolic disease)
Atypical or scar-based flutter
Patients with New York Heart Association Class III at the time of enrollment or New York Heart Association Class IV heart failure within 90 days prior to enrollment
Patients with an ejection fraction less than 30% within 90 days prior to enrollment
Clinically significant structural heart disease (including tricuspid valve regurgitation, tricuspid valve stenosis, tricuspid valve replacement, Ebstein's anomaly, or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator
Any cerebral ischemic event (including transient ischemic attacks) within 180 days prior to enrollment
Contraindication to anticoagulation therapy based upon published guidelines
Creatinine greater than 2.5 mg/dl or creatinine clearance less than 30 mL/min within 90 days prior to enrollment
Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness)
Enrolled in any concurrent study without BSC written approval
Women who are pregnant or plan to become pregnant within the course of their participation in the investigation
Life expectancy less than or equal to 2 years (730 days) per physician opinion

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Emory University Hospital
Atlanta, Georgia, 30308
Georgia Health Sciences University
Augusta, Georgia, 30912
Texas Cardiac Arrhythmia Research
Austin, Texas, 78705
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Medical University of South Carolina
Charleston, South Carolina, 29403
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Colorado Springs Cardiologist, P.C.
Colorado Springs, Colorado, 80907
Ohio State University Medical Center
Columbus, Ohio, 43210
Ohio Health Research Institute
Columbus, Ohio, 43214
Henry Ford Hospital
Detroit, Michigan, 48202
St. Jude Medical Center
Fullerton, California, 92835
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401
Hall Garcia Cardiology
Houston, Texas, 77030
West Coast Arrhythmia Center
Hudson, Florida, 34667
University of Kansas Hospital
Kansas City, Kansas, 66160
Central Baptist Hospital
Lexington, Kentucky, 40503
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Strong Memorial Hospital of the University of Rochester
Rochester, New York, 14642
Regional Cardiology Associates
Sacramento, California, 95819
Swedish Medical Center
Seattle, Washington, 98133
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Clinical Evaluation of the Blazer® Open-Irrigated Radiofrequency Ablation Catheter for the Treatment of Type 1 Atrial Flutter

The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated Ablation Catheter to outcomes in patients treated with open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter.

Read the detailed description

The BLOCk-CTI study is a prospective, multicenter, single blind, 1:1 randomized study. The study 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. In this study, the control catheters are open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter. (Biosense Webster ThermoCool® ablation catheters (NaviStar™, EZ Steer, or SF) or St. Jude Medical ablation catheters (Therapy™ Cool Path™ or Safire BLU™).

Conditions: Atrial Flutter
Being tested: Blazer® Open-Irrigated Ablation Catheter, Control Catheter
Keywords: Type 1 Atrial Flutter, Typical Atrial Flutter, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
Medical subject headings: Atrial Flutter, 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 CatheterDevice
Blazer® Open-Irrigated Ablation Catheter
Control CatheterDevice
Also called ThermoCool, NaviStar, EZ Steer, SF, Cool Path, Safire BLU
Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter

Study groups in NCT01253200
Study group	Role	What they receive
Blazer® Open-Irrigated Ablation Catheter	Experimental	Patients treated with the Blazer® Open-Irrigated Ablation Catheter Receives: Device: Blazer® Open-Irrigated Ablation Catheter
Control Catheter	Active comparator	Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter( Biosense Webster ThermoCool® ablation catheters (NaviStar™, EZ Steer, or SF) or St. Jude Medical ablation catheters (Therapy™ Cool Path™ or Safire BLU™), Receives: Device: Control Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Procedure-related Complication-free Rate
A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.
Measured: 7 days post-procedure
Acute Success Rate
Acute success is defined as demonstration of bidirectional cavo-tricuspid isthmus block (ie, lack of electrophysiological conduction through the isthmus) 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus with the investigational or control catheter only.
Measured: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus

Secondary outcomes (2)

Chronic Success Rate: All Treated Patients
Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.
Measured: 3 months post-procedure
Chronic Success Rate: Acute Success Patients
Chronic success is defined as demonstration of acute success and freedom from recurrence of type 1 atrial flutter at 3-months post-procedure. Only randomized patients with acute procedural success will be included in this endpoint.
Measured: 3-months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Jan 2014

First posted3 Dec 2010 (estimated)
Study startJan 2011
Primary completionSep 2013
Study completionJan 2014

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 Atrial FlutterStudies 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: 302 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01253200
Sponsor's protocol ID: BLOCk-CTI
Acronym: BLOCk-CTI
Status last verified: Feb 2018
First submitted: 21 Nov 2010
Last updated: 19 Mar 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
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Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
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Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
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Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
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All Atrial Flutter trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the Blazer® Open-Irrigated Radiofrequency Ablation Catheter for the Treatment of Type 1 Atrial Flutter
ClinicalTrials.gov ID: NCT01253200
Acronym / sponsor ID: BLOCk-CTI / BLOCk-CTI
Conditions: Atrial Flutter
Keywords: Type 1 Atrial Flutter, Typical Atrial Flutter, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 302 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Sep 2013 (actual)
Study completion: Jan 2014 (actual)
First posted: 3 Dec 2010 (estimated)
Results: Posted 15 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 CatheterPatients treated with the Blazer® Open-Irrigated Ablation Catheter
Control Catheter	Active comparator	Device: Control CatheterPatients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter( Biosense Webster ThermoCool® ablation catheters (NaviStar™, EZ Steer, or SF) or St. Jude Medical ablation catheters (Therapy™ Cool Path™ or Safire BLU™),

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

At least 1 documented episode of type 1 atrial flutter in the 180 days (6 months) preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or transtelephonic monitor
Patients are clinically indicated for catheter ablation
Patients receiving oral anti-arrhythmic drug therapy (class I or class III) for a tachyarrhythmia other than type 1 atrial flutter must be controlled on the anti-arrhythmic drug for a minimum of 30 days prior to enrollment. If type 1 atrial flutter was documented prior to the development of other tachyarrhythmias, this 30-day period is not required.
Age 18 or above, or of legal age to give informed consent specific to state and national law
Patients are competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation

Key exclusion criteria (20 listed)

Any prior right atrial cavo-tricuspid isthmus ablation or any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment
Cardiac surgery within 90 days prior to enrollment
Myocardial infarction within 60 days prior to enrollment
Current unstable angina
Patients who cannot have anti-arrhythmic drugs (class I and class III) prescribed for the treatment of type 1 atrial flutter stopped on the day of the procedure

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 CatheterBlazer® Open-Irrigated Ablation Catheter	Device	Blazer® Open-Irrigated Ablation Catheter
Control CatheterAlso: ThermoCool, NaviStar, EZ Steer, SF, Cool Path, Safire BLUOpen-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter	Device	Control Catheter

Primary outcome

Procedure-related Complication-free Rate
Time frame: 7 days post-procedure
A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.
Acute Success Rate
Time frame: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus
Acute success is defined as demonstration of bidirectional cavo-tricuspid isthmus block (ie, lack of electrophysiological conduction through the isthmus) 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus with the investigational or control catheter only.

2 secondary outcomes

Chronic Success Rate: All Treated Patients
Time frame: 3 months post-procedure
Chronic Success Rate: Acute Success Patients
Time frame: 3-months post-procedure

Results and safety

Results posted to the registry on 15 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized Blazer® Open-Irrigated Ablation Catheter	125	104
Randomized Control Catheter	125	106
Roll-in Blazer Open Irrigated Subjects	30	28
Roll-in Control Catheter	17	12
Not Randomized to Any Treatment Group Subjects	5	0

Primary outcome: Procedure-related Complication-free Rate

Time frame: 7 days post-procedure. Number. Unit: percentage of subjects

Measure	Blazer® Open-Irrigated Ablation Catheter n = 109	Control Catheter n = 111
Value	92.7	98.2

Blazer® Open-Irrigated Ablation Catheter vs Control Catheter: Risk Difference (RD): 4.6

Population analysed: The primary outcome analysis is for a further subset of Randomized subjects only who underwent RF ablation; 220 subjects out of the total 302 subjects. All is consistent with the approved statistical analysis plan and information publicly available in the FDA Summary of Safety and Effectiveness Data (SSED) and BSC labeling, the Directions for Use.

Primary outcome: Acute Success Rate

Time frame: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus. Number. Unit: percentage of success

Measure	Blazer® Open-Irrigated Ablation Catheter n = 109	Control Catheter n = 111
Value	87.2	89.2

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 3 months of the index RF ablation procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized Blazer® Open-Irrigated Ablation Catheter	7 of 109 (6.4%)	50 of 109 (45.9%)	1 of 125
Randomized Control Catheter	2 of 111 (1.8%)	61 of 111 (55%)	0 of 125
Roll-in Blazer® Open-Irrigated Ablation Catheter	5 of 28 (17.9%)	16 of 28 (57.1%)	0 of 30
Roll-in Control Catheter	2 of 12 (16.7%)	7 of 12 (58.3%)	0 of 17
Non-Randomized to Any Treatment Group	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): Two interim study suspensions occurred during enrollment that did not impact the integrity of the data and subsequent analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atrial Flutter

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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.

Tom McElderry, MD principal investigator

University of Alabama at Birmingham

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Blazer® Open-Irrigated Ablation Catheter in people with Atrial Flutter, run by Boston Scientific Corporation at 26 sites in United States.

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 5 inclusion and 20 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. 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 15 Feb 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: 7 days post-procedure). 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?

On the ClinicalTrials.gov record for NCT01253200.

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 19 Mar 2018.