A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach

January 12, 2016 updated by: Thomas Rostock, Johannes Gutenberg University Mainz
This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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
      • Mainz, Germany, 55131
        • University Hospital Mainz, Department of Medicine II

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • persistent atrial fibrillation lasting longer than 3 months
  • no previous ablations
  • at least 1 electrical cardioversion

Exclusion Criteria:

  • non-persistent atrial fibrillation
  • previous ablation procedures

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A: stepwise ablation
Stepwise ablation of persistent atrial fibrillation (conventional treatment arm) In this arm, patients will be treated with the conventional stepwiese ablation approach
Procedure: Ablation
In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms.
Active Comparator: Group B: sequential substrate ablation
Sequential substrate ablation of persistent atrial fibrillation (novel procedure) In this arm, patients will undergo an ablation procedure that consist of PVI, cardioversion, linear ablation and atrial fibrillation re-induction after blocked lines, followed by electrogram-guided ablation
Procedure: Ablation
In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients without any arrhythmias during follow-up of 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Thomas Rostock, MD, University Hospital Mainz, Department of Cardiology

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, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 9, 2016

First Submitted That Met QC Criteria

January 12, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PersAF-Abl2014

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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