Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
NAFAPAF
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedMay 26, 2010
January 1, 2010
11 months
January 26, 2010
May 25, 2010
Conditions
Keywords
Outcome Measures
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
1 year
Study Arms (2)
AF ablation and AV node ablation
EXPERIMENTALPatients will receive the combined procedure of AF ablation as well as AV node ablation
AV node ablation
ACTIVE COMPARATORPatient will receive AV node ablation alone
Interventions
AF ablation and AV node ablation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
February 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2012
Last Updated
May 26, 2010
Record last verified: 2010-01