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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01401361
First received: July 21, 2011
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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

Condition Intervention Phase
Typical Atrial Flutter
Device: Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.

  • Primary Efficacy [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Secondary Efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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.



Enrollment: 150
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm Device: Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system
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 .

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401361

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01401361     History of Changes
Other Study ID Numbers: 90064772
Study First Received: July 21, 2011
Results First Received: November 4, 2013
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 01, 2014