Gen2 Isthmus-Dependent Atrial Flutter Ablation Study

July 13, 2023 updated by: Abbott Medical Devices

Gen2 Cardiac Ablation System Isthmus-Dependent Atrial Flutter Study

Irrigated catheter for ablation of isthmus-dependent atrial flutter

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • University of Alabama Birmingham
    • New Jersey
      • West Orange, New Jersey, United States
        • St. Barnabus Medical Center
    • Pennsylvania
      • Doylestown, Pennsylvania, United States
        • Doylestown Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter
Device: Cardiac Ablation (Gen2 Cardiac Ablation System)
Ablation of isthmus-dependent atrial flutter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intraprocedural, serious cardiac adverse event
Time Frame: 7 days post-procedure
Defined as the Incidence of intraprocedural, serious cardiac adverse event
7 days post-procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Vance Plumb, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 21, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimated)

February 4, 2008

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0611.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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