Back to resultsGen2 Isthmus-Dependent Atrial Flutter Ablation Study
Primary Purpose
Atrial Flutter
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Ablation (Gen2 Cardiac Ablation System)
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter
Eligibility 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
Sites / Locations
- University of Alabama Birmingham
- St. Barnabus Medical Center
- Doylestown Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
(Gen2 Cardiac Ablation System)
Arm Description
Ablation of isthmus-dependent atrial flutter
Outcomes
Primary Outcome Measures
Incidence of intraprocedural, serious cardiac adverse event
Defined as the Incidence of intraprocedural, serious cardiac adverse event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00606463
Brief Title
Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
Official Title
Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Abbott funding allocated to a different project.
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(Gen2 Cardiac Ablation System)
Arm Type
Experimental
Arm Description
Ablation of isthmus-dependent atrial flutter
Intervention Type
Device
Intervention Name(s)
Cardiac Ablation (Gen2 Cardiac Ablation System)
Intervention Description
Ablation of isthmus-dependent atrial flutter
Primary Outcome Measure Information:
Title
Incidence of intraprocedural, serious cardiac adverse event
Description
Defined as the Incidence of intraprocedural, serious cardiac adverse event
Time Frame
7 days post-procedure
Other Pre-specified Outcome Measures:
Title
Bi-direction block and non-inducibility of atrial flutter
Description
Acute Procedure success defined as bi-directional block and non-inducibility of atrial flutter
Time Frame
Procedural
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vance Plumb, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
St. Barnabus Medical Center
City
West Orange
State/Province
New Jersey
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gen2 Isthmus-Dependent Atrial Flutter Ablation Study
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