Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation (NAFAPAF)
Primary Purpose
Persistent Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AF ablation and AV node ablation
AV node ablation
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial Fibrillation, Ablation
Eligibility Criteria
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).
Sites / Locations
- Eastbourne District General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AF ablation and AV node ablation
AV node ablation
Arm Description
Patients will receive the combined procedure of AF ablation as well as AV node ablation
Patient will receive AV node ablation alone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01057485
First Posted
January 26, 2010
Last Updated
May 25, 2010
Sponsor
Eastbourne General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01057485
Brief Title
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
Acronym
NAFAPAF
Official Title
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Eastbourne General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Atrial Fibrillation, Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AF ablation and AV node ablation
Arm Type
Experimental
Arm Description
Patients will receive the combined procedure of AF ablation as well as AV node ablation
Arm Title
AV node ablation
Arm Type
Active Comparator
Arm Description
Patient will receive AV node ablation alone
Intervention Type
Procedure
Intervention Name(s)
AF ablation and AV node ablation
Intervention Description
AF ablation and AV node ablation
Intervention Type
Procedure
Intervention Name(s)
AV node ablation
Intervention Description
AV node ablation
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven J Podd, MBBS, MA, MRCP
Phone
01323 417400
Ext
4132
Email
steven.podd@esht.nhs.uk
Facility Information:
Facility Name
Eastbourne District General Hospital
City
Eastbourne
State/Province
East Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven J Podd, MBBS, MA, MRCP
Phone
01323 417400
Ext
4132
Email
stevenpodd@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
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