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NCT00606463 Clinical Trial

Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

Atrial Flutter Clinical Trial

Official title:
Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00606463
Other study ID # 0611.1
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2008
Est. completion date January 2009

Study information
Verified date July 2023
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Irrigated catheter for ablation of isthmus-dependent atrial flutter

Description:

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

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date January 2009
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cardiac Ablation (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter

Locations
Country Name City State
United States University of Alabama Birmingham Birmingham Alabama
United States Doylestown Hospital Doylestown Pennsylvania
United States St. Barnabus Medical Center West Orange New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Bi-direction block and non-inducibility of atrial flutter Acute Procedure success defined as bi-directional block and non-inducibility of atrial flutter Procedural
Primary Incidence of intraprocedural, serious cardiac adverse event Defined as the Incidence of intraprocedural, serious cardiac adverse event 7 days post-procedure
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