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

NCT01253200 | Completed Results FDA Device

• 1 other identifier: BLOCk-CTI
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 26

Brief Summary

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.

Conditions

Atrial Flutter

Keywords

Type 1 Atrial Flutter; Typical Atrial Flutter; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus

Secondary Outcomes (2)

• Chronic Success Rate: All Treated Patients

  3 months post-procedure

• Chronic Success Rate: Acute Success Patients

  3-months post-procedure

Study Arms (2)

Blazer® Open-Irrigated Ablation Catheter

EXPERIMENTAL

Patients treated with the Blazer® Open-Irrigated Ablation Catheter

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™),

Device: Control Catheter

Interventions

Blazer® Open-Irrigated Ablation Catheter DEVICE

Blazer® Open-Irrigated Ablation Catheter

Blazer® Open-Irrigated Ablation Catheter

Control Catheter DEVICE

Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter

Also known as: ThermoCool, NaviStar, EZ Steer, SF, Cool Path, Safire BLU

Control Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (26)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

Regional Cardiology Associates

Sacramento, California, 95819, United States

Location

Colorado Springs Cardiologist, P.C.

Colorado Springs, Colorado, 80907, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

West Coast Arrhythmia Center

Hudson, Florida, 34667, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Strong Memorial Hospital of the University of Rochester

Rochester, New York, 14642, United States

Location

Moses H. Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States

Location

Hall Garcia Cardiology

Houston, Texas, 77030, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Atrial Flutter; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Two interim study suspensions occurred during enrollment that did not impact the integrity of the data and subsequent analyses.

Results Point of Contact

• Title: Timothy Meyer; Director of Clinical Trials
• Organization: Boston Scientific

Timothy.meyer@bsci.com

651 581 3425

Study Officials

• Tom McElderry, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subject was not told by investigator if device used was Investigational or Control. The subject could ask the investigator at end of study at 3 months if they wanted to know which device was used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2010
• First Posted: December 3, 2010
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 19, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)