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

Primary Purpose

Typical Atrial Flutter

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Treatment Arm
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Typical Atrial Flutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology, P.C.
  • Aurora Denver Cardiology
  • Hartford Hospital
  • St. Vincent's Hospital
  • Emory University Hospital
  • University of Chicago
  • Ochsner Medical Center
  • New York University Langone Medical Center - Tisch Hospital
  • University of Rochester
  • University of North Carolina at Chapel Hill
  • Presbyterian Hospital
  • Ohio Health Research Institute - GMC
  • Providence St. Vincent Medical Center
  • Doylestown Hospital
  • Texas Health Research & Education Institute
  • Memorial Hermann Hospital
  • St. Luke's Episcopal Hospital
  • Scott & White Memorial Hospital
  • Virginia Cardiovascular Specialists
  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 21, 2011
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01401361
Brief Title
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
Acronym
CONTACT_AFL
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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 Validation of ECI against conventional methods of assessing tip tissue contact and 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Atrial Flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Treatment Arm
Other Intervention Name(s)
Ablation with Contact Therapy Cool Path system
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure
Description
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.
Time Frame
7 days
Title
Primary Efficacy
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Secondary Efficacy
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Chinitz, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Aurora Denver Cardiology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
St. Vincent's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
New York University Langone Medical Center - Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Ohio Health Research Institute - GMC
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Texas Health Research & Education Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Virginia Cardiovascular Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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