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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: March 12, 2014
Last verified: March 2014

July 21, 2011
March 12, 2014
October 2011
April 2012   (final data collection date for primary outcome measure)
  • 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.
  • Primary Safety [ 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.
Complete list of historical versions of study NCT01401361 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter
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

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
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Typical Atrial Flutter
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 .
Experimental: Treatment Arm
Intervention: Device: Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01401361
90064772
Yes
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Larry Chinitz, MD New York University Langone Medical Center
St. Jude Medical
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP