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

Typical Atrial Flutter Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401361
• Other study ID #: 90064772
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Typical Atrial Flutter

Intervention

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 .

Locations

Country	Name	City	State
Canada	Institut de Cardiologie de Montreal (Montreal Heart Inst.)	Montreal	Quebec
United States	Emory University Hospital	Atlanta	Georgia
United States	Cardiology, P.C.	Birmingham	Alabama
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Presbyterian Hospital	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Ohio Health Research Institute - GMC	Columbus	Ohio
United States	Texas Health Research & Education Institute	Dallas	Texas
United States	Aurora Denver Cardiology	Denver	Colorado
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	Hartford Hospital	Hartford	Connecticut
United States	Memorial Hermann Hospital	Houston	Texas
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	St. Vincent's Hospital	Jacksonville	Florida
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	New York University Langone Medical Center - Tisch Hospital	New York	New York
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	University of Rochester	Rochester	New York
United States	Scott & White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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