Long-Standing Persistant Atrial Fibrillation-Pulmonary Vein Isolation With or Without Ablation (Alster-Lost)

February 6, 2017 updated by: Asklepios proresearch

Ablation at St. Georg Hospital for Long-Standing Persistent Atrial Fibrillation - Pulmonary Vein Isolation With or Without Ablation of Complex Fragmented Atrial Potentials

The chronic success rate, defined as freedom from any atrial tachyarrhythmias will increase from 35% to 60% by ablation of complex fragmented atrial electrograms potentials in addition to pulmonary vein isolation (PVI) as compared to PVI alone in patients with long-standing persistent AF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

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
      • Hamburg, Germany
        • Asklepios Klinik St. Georg

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:

  • long standing persistent atrial fibrillation > 6 months and < 5 years

Exclusion Criteria:

  • renal failure
  • left atrial size >55 mm

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ablation: pulmonary vein isolation
Procedure: pulmonary vein isolation
common pulmonary vein isolation procedure
Active Comparator: 2
ablation: pulmonary vein isolation with additional ablation of fragmented potentials
Procedure: pulmonary vein isolation with additional ablation of fragmented potentials
common pulmonary vein isolation with additional but also common ablation of fragmented potentials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
data collection in view of acute and chronic success rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
data collection of complications in both groups and also procedure parameters
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Asklepios proresearch

Investigators

  • Principal Investigator: Karl-Heinz Kuck, PhD, MD, Asklepios Klinik St. Georg, Department of Cardiology

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, 2008

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1787
  • PV 2961 (Other Identifier: Ethical Board Hamburg)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Atrial Fibrillation

Clinical Trials on pulmonary vein isolation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe