Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01057485

Acronym

NAFAPAF

Enrollment

Registered

2010-01-27

Start date

2010-02-28

Completion date

2012-01-31

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Keywords

Atrial Fibrillation, Ablation

Brief 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.

Interventions

PROCEDUREAF ablation and AV node ablation

AF ablation and AV node ablation

PROCEDUREAV node ablation

AV node ablation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

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	1 year

Countries

United Kingdom

Contacts

Primary ContactSteven J Podd, MBBS, MA, MRCP

steven.podd@esht.nhs.uk01323 417400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026