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Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00606463
First received: January 21, 2008
Last updated: April 21, 2017
Last verified: April 2017
  Purpose
Irrigated catheter for ablation of isthmus-dependent atrial flutter

Condition Intervention
Atrial Flutter Device: Cardiac Ablation (Gen2 Cardiac Ablation System)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Incidence of intraprocedural, serious cardiac adverse event [ Time Frame: 7 days post-procedure ]
    Defined as the Incidence of intraprocedural, serious cardiac adverse event


Other Outcome Measures:
  • Bi-direction block and non-inducibility of atrial flutter [ Time Frame: Procedural ]
    Acute Procedure success defined as bi-directional block and non-inducibility of atrial flutter


Enrollment: 30
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter
Device: Cardiac Ablation (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter

Detailed Description:
This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for ablation of isthmus-dependent atrial flutter

Exclusion Criteria:

  • Prior ablation of isthmus-dependent atrial flutter
  • Atypical or scar flutter
  • Significant heart disease
  • Intracardiac thrombus
  • Prior cardiac surgery (within 1 month)
  • Contraindication to heparin
  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: NCT00606463

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States
United States, New Jersey
St. Barnabus Medical Center
West Orange, New Jersey, United States
United States, Pennsylvania
Doylestown Hospital
Doylestown, Pennsylvania, United States
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Vance Plumb, MD University of Alabama at Birmingham
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00606463     History of Changes
Other Study ID Numbers: 0611.1
Study First Received: January 21, 2008
Last Updated: April 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

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

ClinicalTrials.gov processed this record on August 16, 2017