Persistent Atrial FibrillationNAFAPAFNCT01057485
Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
A study testing AF ablation and AV node ablation and AV node ablation in people with Persistent Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- AF ablation and AV node ablation and AV node ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD
Steven J Podd, MBBS, MA, MRCP, 01323 417400 ext. 4132, stevenpodd@yahoo.com
About this study
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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- AF ablation and AV node ablation, AV node ablation
- Keywords
- Atrial Fibrillation, Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF ablation and AV node ablationProcedure or surgery
AF ablation and AV node ablation
AV node ablationProcedure or surgery
AV node ablation
| Study group | Role | What they receive |
|---|---|---|
| AF ablation and AV node ablation | Experimental | Patients will receive the combined procedure of AF ablation as well as AV node ablation Receives: Procedure: AF ablation and AV node ablation |
| AV node ablation | Active comparator | Patient will receive AV node ablation alone Receives: Procedure: AV node ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057485
- Sponsor's protocol ID
- NAFAPAFv1.3
- Acronym
- NAFAPAF
- Status last verified
- Jan 2010
- First submitted
- 26 Jan 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Node and Atrial Fibrillation Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01057485
- Acronym / sponsor ID
- NAFAPAF / NAFAPAFv1.3
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF ablation and AV node ablation | Experimental | Procedure: AF ablation and AV node ablationPatients will receive the combined procedure of AF ablation as well as AV node ablation |
| AV node ablation | Active comparator | Procedure: AV node ablationPatient will receive AV node ablation alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF ablation and AV node ablationAF ablation and AV node ablation | Procedure or surgery | AF ablation and AV node ablation |
| AV node ablationAV node ablation | Procedure or surgery | AV node ablation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF ablation and AV node ablation and AV node ablation in people with Persistent Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven J Podd, MBBS, MA, MRCP (01323 417400 ext. 4132, steven.podd@esht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2010.