Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System (CONTACT_AFL)

Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter

To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter

• Does not result into unacceptable risk of intra-procedural composite serious adverse events and,
• Does not affect efficacy of the ablation procedure The study will also evaluate the

Study Overview

• Status: Completed
• Conditions: Typical Atrial Flutter
• Intervention / Treatment: Device: Treatment Arm

Detailed Description

This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study

1. Validation of ECI against conventional methods of assessing tip tissue contact and

2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:

   • ECG
   • Query regarding adverse events since the last visit
   • Assessment of anti-arrhythmic and anti-coagulation medication
   • Query regarding recurrence or repeat ablation for typical atrial flutter

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology, P.C.
  • Colorado
    • Denver, Colorado, United States, 80012
      • Aurora Denver Cardiology
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center - Tisch Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Hospital
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Ohio Health Research Institute - GMC
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Health Research & Education Institute
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Virginia Cardiovascular Specialists

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 (cavo-tricuspid isthmus dependent)
• If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a 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
• Clinically significant tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve.
• Evidence of intracardiac thrombus or a history of clotting disorders
• Participation in another investigational study
• Cardiac surgery within 1 month prior to the intended procedure date
• Allergy or contraindication to Heparin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Atrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement.	Device: Treatment Arm; The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .; Other Names: Ablation with Contact Therapy Cool Path system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure	Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.	7 days
Primary Efficacy	Primary efficacy or Acute success is defined as achievement of 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 investigational system.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy	Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a, 1c, III) during the 3 months post ablation are considered chronic failures.	3 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Larry Chinitz, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 90064772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO