Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

NCT01687166 | Completed Results

• 1 other identifier: CDM00048665
• Study Type: interventional
• Target: 398
• Locations: 9 countries
• Sites: 38

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.

Conditions

Paroxysmal Atrial Fibrillation (PAF)

Keywords

Paroxysmal Atrial Fibrillation; Cardiac Arrhythmias; Heart Disease; Cardiovascular Disease; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Within 12 months of the index procedure

Secondary Outcomes (1)

• Acute Success

  Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation

Study Arms (2)

Blazer Open-Irrigated Ablation Catheter

EXPERIMENTAL

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

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.

Device: FDA Approved Open-Irrigated Ablation Catheter

Interventions

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (38)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Hunstville Hospital

Huntsville, Alabama, 35801, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Baptist Hospital

Pensacola, Florida, 32501, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30308, United States

Location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21229, United States

Location

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109-5853, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

New York University

New York, New York, 10016, United States

Location

Mt. Sinai Medical Center

New York, New York, 10029, United States

Location

Strong Memorial Hospital of the University of Rochester

Rochester, New York, 14642, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Trinity Mother of Frances Health System

Tyler, Texas, 75701, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Heart Care Partners

Brisbane, Queensland, QL 4120 QLD, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, SA 5000, Australia

Location

Na Homolce Hospital

Prague, Czechia

Location

CHU of Bordeaux

Pessac, Gironde, 33600, France

Location

Charité University Berlin

Berlin, 13353, Germany

Location

Staedtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Centro Hospital de Santa Cruz

Carnaxide, Portugal

Location

Hospital Clinico Y Provincial

Barcelona, 8036, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Boston Scientific

weismanm@bsci.com

617-218-3849

Study Officials

• Andrea Natale, M.D.

  Texas Cardiac Arrhythmia Institute at St. David's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 18, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 21, 2018
• Results First Posted: June 18, 2018

Record last verified: 2018-10

Locations

ES (2); SE (1); GB (1); FR (1); US (27); PT (1); CZ (1); DE (2); AU (2)