Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation (NAFAPAF)

May 25, 2010 updated by: Eastbourne General Hospital
The purpose of the study is to assess combining AF ablation, with AV node ablation and pacemaker implantation for patients suffering with 'irregular heartbeats' or atrial fibrillation. The study will last 13 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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 Kingdom
    • East Sussex
      • Eastbourne, East Sussex, United Kingdom, BN21 2UD
        • Recruiting
        • Eastbourne District General Hospital
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symptomatic drug refractory atrial fibrillation.
  • Patients who have had pacemaker implantation and AV node ablation with ongoing symptoms.
  • Patients will already be refractory to at least 2 rate or rhythm control drugs.
  • Patients must be over 18 years old.
  • Patients give informed consent form prior to participating in this study.

Exclusion Criteria:

  • Patient is suffering with unstable angina in last 1 week.
  • Patient has had a myocardial infarction within last 2 months.
  • Patient is expecting or has had major cardiac surgery within last 2 months.
  • Patient is participating in a conflicting study.
  • Patient is unable to perform exercise testing.
  • Patient is mentally incapacitated and cannot consent or comply with follow-up.
  • Patient has NYHA class III/ IV heart failure.
  • Patient has LVEF <35% not secondary to tachycardia.
  • Pregnancy.
  • Patient suffers with other cardiac rhythm disorders.
  • Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).

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: AF ablation and AV node ablation
Patients will receive the combined procedure of AF ablation as well as AV node ablation
Procedure: AF ablation and AV node ablation
AF ablation and AV node ablation
ACTIVE_COMPARATOR: AV node ablation
Patient will receive AV node ablation alone
Procedure: AV node ablation
AV node ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the two treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.To measure the two treatment effects on 6-minute hall walk distance.Echocardiographic parameters
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Eastbourne General Hospital

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, 2010

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

January 1, 2012

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (ESTIMATE)

January 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 26, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFAPAFv1.3

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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