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

NCT01401361 | Completed Phase 3 Results DMC

• 1 other identifier: 90064772
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 20

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

Conditions

Typical Atrial Flutter

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Secondary Efficacy

  3 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

Treatment Arm DEVICE

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 .

Also known as: Ablation with Contact Therapy Cool Path system

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Agree to comply with follow-up visits and evaluation

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (20)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Aurora Denver Cardiology

Denver, Colorado, 80012, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

St. Vincent's Hospital

Jacksonville, Florida, 32204, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

New York University Langone Medical Center - Tisch Hospital

New York, New York, 10016, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Ohio Health Research Institute - GMC

Columbus, Ohio, 43215, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Texas Health Research & Education Institute

Dallas, Texas, 75231, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Virginia Cardiovascular Specialists

Richmond, Virginia, 23229, United States

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T 1C8, Canada

Location

Results Point of Contact

• Title: Nancy Ouch
• Organization: St. Jude Medical

NOuch@sjm.com

+19497695041

Study Officials

• Larry Chinitz, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 15, 2019
• Results First Posted: December 23, 2013

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); CA (1)