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Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

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ClinicalTrials.gov Identifier: NCT00606463
Recruitment Status : Terminated (Abbott funding allocated to a different project.)
First Posted : February 4, 2008
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE January 21, 2008
First Posted Date  ICMJE February 4, 2008
Last Update Posted Date August 11, 2020
Study Start Date  ICMJE February 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
Incidence of intraprocedural, serious cardiac adverse event [ Time Frame: 7 days post-procedure ]
Defined as the Incidence of intraprocedural, serious cardiac adverse event
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 21, 2017)
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
Official Title  ICMJE Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study
Brief Summary Irrigated catheter for ablation of isthmus-dependent atrial flutter
Detailed Description This study intends to use an investigational irrigated catheter for ablation of isthmus-dependent atrial flutter
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Flutter
Intervention  ICMJE Device: Cardiac Ablation (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter
Study Arms  ICMJE Experimental: (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter
Intervention: Device: Cardiac Ablation (Gen2 Cardiac Ablation System)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 21, 2017)
30
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606463
Other Study ID Numbers  ICMJE 0611.1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vance Plumb, MD University of Alabama at Birmingham
PRS Account Abbott Medical Devices
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP