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Status unknownNCT01057485NAFAPAFUpdated May 26, 2010

Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

An interventional study of AF ablation and AV node ablation and AV node ablation in Persistent Atrial Fibrillation, sponsored by Eastbourne General Hospital. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-05-26.

Sponsored by Eastbourne General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Persistent Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
  • Ablation
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 50 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Eastbourne General Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • Active comparator
    AV node ablation

    Patient will receive AV node ablation alone

    Procedure: AV node ablation

Interventions

  • ProcedureAF ablation and AV node ablation

    AF ablation and AV node ablation

  • ProcedureAV node ablation

    AV node ablation

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Eastbourne District General Hospital
    Eastbourne, East Sussex BN21 2UD, United Kingdom
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2010, a primary completion of Jan 2011 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2010
First posted
Jan 27, 2010
Start
Feb 2010
Primary completionEst.
Jan 2011
CompletionEst.
Jan 2012
Last update
May 26, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01057485
Lead sponsor
Eastbourne General Hospital
First posted
Jan 27, 2010
Start date
Feb 2010
Primary completion
Jan 2011 (estimated)
Completion
Jan 2012 (estimated)
Last update
May 26, 2010

Study contacts

Steven J Podd, MBBS, MA, MRCP
Contact
steven.podd@esht.nhs.uk
01323 417400 ext. 4132

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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