Efficacy and Safety Study on Agilis NxT Introducer in AF Patients (AGILIS)

February 1, 2019 updated by: Abbott Medical Devices

Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.

Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up

Study Type

Interventional

Enrollment (Anticipated)

130

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

  • Germany
      • Leipzig, Germany, 04289
        • Herzzenturm Leipzig

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 to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Paroxysmal or persistent symptomatic atrial fibrillation
  • Resistant to at least 1 anti arrhythmic drug
  • Left atrial diameter less then 60 mm (TTE, parasternal)
  • Atrial fibrillation documented by ECG
  • Patient is willing and available to perform all Follow Ups

Exclusion Criteria:

  • Permanent atrial fibrillation
  • Pre existing left atrial fibrillation ablation
  • Atrial fibrillation due to reversible cause
  • Known intracardiac or other thrombi
  • Pregnancy
  • Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
  • Contraindication for anticoagulation

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Agilis sheeth group
Procedure: Left atrial catheter ablation guided by introducer using Agilis sheeth
Left atrial catheter ablation guided by introducer using Agilis sheeth
ACTIVE_COMPARATOR: Non-steerable sheeth group
Procedure: Left atrial catheter ablation guided by introducer using Non-steerable sheeth
Left atrial catheter ablation guided by introducer using Non-steerable sheeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
Time Frame: 6 months post ablation
6 months post ablation

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration
Time Frame: 6 month post ablation
6 month post ablation

Collaborators and Investigators

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

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Gerhard Hindricks, Prof. Dr., Herzzentrum Leipzig, Abteilung für Rhythmologie, Strümpellstraße 39, 04289 Leipzig, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2007

Primary Completion (ACTUAL)

April 1, 2010

Study Completion (ACTUAL)

April 1, 2010

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (ESTIMATE)

May 4, 2007

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A07

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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