Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00318565
First received: April 25, 2006
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).


Condition Intervention Phase
Atrial Flutter
Device: RF energy delivery for treatment of Typical Atrial flutter
Phase 4

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: Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter

Further study details as provided by Biosense Webster, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects With Complete Bidirectional Conduction Block. [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    Acute success is defined as the confirmation of complete bidirectional conduction block across the subeustachian (cavo-tricuspid) isthmus. The percentage of subjects with confirmed conduction block will serve as the outcome measure.

  • Percentage of Subjects Experiencing Cardiovascular Specific Adverse Events (CSAE) Within Seven (7) Days of the Ablation Procedure. [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
    The cardiovascular specific adverse event (CSAE) rate is the primary safety enpoint for the study. A CSAE is an event which occurs within the first week (7 days) following use of the device and is one of the following cardiac specific adverse events: cardiac perforation, pericardial effusion, pulmonary embolus, complete heart block, stroke, acute myocardial infarction, and death.


Enrollment: 291
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Navistar ThermoCool Catheter Device: RF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter
Other Name: Therapeutic Catheters

Detailed Description:

This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.

  Eligibility

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

Inclusion Criteria:

  • Two symptomatic episodes of typical atrial flutter (or chronic atrial flutter) during the one-year period prior to enrollment. This may include typical AFL occurring while receiving anti-arrhythmic drug (AAD) therapy for non-AFL tachyarrhythmia, including atrial fibrillation.
  • At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
  • 18 years of age or older
  • Informed consent

Exclusion Criteria:

  • Intracardiac thrombus
  • Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
  • Women who are pregnant
  • Cardiac surgery (ventriculotomy or atriotomy) within the past two months
  • Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
  • Unstable angina or acute myocardial infarction within 3 months
  • Awaiting cardiac transplantation
  • Heart disease in which corrective surgery is anticipated within 6 months
  • Presence of condition that precludes appropriate vascular access
  • Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
  • High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
  • Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
  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: NCT00318565

  Show 23 Study Locations
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Warren Jackman, M.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00318565     History of Changes
Other Study ID Numbers: BWI30031
Study First Received: April 25, 2006
Results First Received: July 8, 2009
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biosense Webster, Inc.:
Heart Disease
Atrial Flutter
Typical Atrial Flutter

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

ClinicalTrials.gov processed this record on September 18, 2014