Clinical Evaluation of Therapy™ Cool Path™ Duo Cardiac Ablation System for the Treatment of Typical Atrial Flutter (AFL)

The purpose of this study is to demonstrate that ablation with the Therapy™ Cool Path™ Duo cardiac ablation system can eliminate typical atrial flutter and that its use does not result in an unacceptable risk of serious adverse events (SAE's).

Study Overview

• Status: Completed
• Conditions: Typical Atrial Flutter
• Intervention / Treatment: Device: Therapy Cool Path Duo

Detailed Description

This is a prospective, multi-center, non-randomized study (historical data as control) for the evaluating the safety and efficacy of Therapy TM Cool PathTM

Duo Ablation System for the treatment of typical atrial flutter (Cavo-triscupid isthmus dependent)

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • Institut de Cardiologie de Quebec
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 4R2
      • Victoria Cardiac Arrhythmia Trials, Inc.
• United States
  • California
    • Sacramento, California, United States, 95819
      • Regional Cardiology Associates
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
    • Greensboro, North Carolina, United States, 27401
      • Moses Cone Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State Medical
    • Mayfield Heights, Ohio, United States, 44124
      • Cardiovascular Associates of Cleveland
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • Main Line Health Center/Lankenau
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Virginia Hospital Center
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A signed written Informed Consent
• Presence of typical atrial flutter (cavotricuspid isthmus dependent)
• If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD)for an arrhythmia other than typical atrial flutter, then the subject needs to be controlled on their medication for at least 3 months. If the subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.
• One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months
• In good physical health
• 18 years of age or older
• Agree to comply with follow-up visits and evaluation

Exclusion Criteria:

• Prior typical atrial flutter ablation treatment
• Pregnancy
• Atypical flutter or scar flutter(non-isthmus dependent)
• Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment
• A recent myocardial infarction within 3 months of the intended procedure date
• Permanent coronary sinus pacing lead
• Tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve (i.e. significant)
• Evidence of intracardiac thrombus or a history of clotting disorders
• Participation in another investigational study
• Cardiac surgery within 1 month of the intended procedure date
• Allergy or contraindication to Heparin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment arm	Device: Therapy Cool Path Duo; All patients will be treated with Therapy Cool Path Duo Ablation System for the treatment of typical atrial flutter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Safety- Incidence of Intra Procedural Serious Cardiac Adverse Events Occuring Within 7 Days of Post-procedure, Regardless of Whether a Determination Can be Made Regarding Device Relatedness.	7 days
Primary Efficacy- Bidirectional Block in the Cavo-tricuspid Isthmus and Non-inducibility of Typical Atrial Flutter at Least 30 Minutes Following the Last RF Ablation With the Cool Path Duo Ablation Catheter System is Obtained.	30 mins

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary Efficacy- Freedom From Recurrence of Typical Atrial Flutter up to 3 Months Post Procedure	3 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 23, 2009
• First Posted (Estimate): September 25, 2009

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cavo-tricuspid dependent
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 90030638