Atrial FibrillationSMAAN-PAFNCT01445925
Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)
A study testing Pulmonary vein isolation (PVI), Pulmonary vein isolation + linear lesions and Pharmacological Substrate modification in people with Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation (PVI), Pulmonary vein isolation + linear lesions and Pharmacological Substrate modification
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2011to Nov 2014
- 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
- Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
- Non-paroxysmal atrial fibrillation, as pre-classified as
- Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting >7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
- Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
- Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting >12 hours but less than 7 days plus one or more of the following:
- Age >65 years 21
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- Individual AF episode(s) lasting >24 hours
- Significant left atrial dilatation of >45 mm on Echo (Parasternal Long Axis view)
- Obesity (Body Mass Index >30), and/ or history suggestive of sleep apnoea
- Diabetes Mellitus requiring hypoglycaemic drugs and/or Insulin
Who cannot join
- Inability or unwillingness to receive oral anticoagulation with warfarin
- Previous Ablation procedure for AF
- Unwillingness or inability to complete the required follow up arrangements
- Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
- Documented typical atrial flutter
- Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
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- Contraindications and/ or prior intolerance to both Amiodarone and Flecainide.
- Reversible cause for atrial fibrillation
- Known hypertrophic or infiltrative cardiomyopathy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Royal Brompton and Harefield Hospitals NHS Trust
London
About this study
Official title: Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.
- Conditions
- Atrial Fibrillation
- Being tested
- Pulmonary vein isolation (PVI), Pulmonary vein isolation + linear lesions, Pharmacological Substrate modification
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolation (PVI)Procedure or surgery
Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm
Pulmonary vein isolation + linear lesionsProcedure or surgery
Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres.
Pharmacological Substrate modificationDrug
at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Patients will undergo pulmonary venous isolation plus pharmacological substrate modification Receives: Procedure: Pulmonary vein isolation (PVI); Drug: Pharmacological Substrate modification |
| Pulmonary vein isolation + Linear Lesions | Experimental | Patients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification Receives: Procedure: Pulmonary vein isolation + linear lesions; Drug: Pharmacological Substrate modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
Defined as >30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhiraj Gupta, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Investigators
- Dhiraj Gupta, MD DM MRCP, Principal investigator, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445925
- Sponsor's protocol ID
- LHCH901
- Acronym
- SMAAN-PAF
- Status last verified
- Aug 2013
- First submitted
- 30 Sep 2011
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wynn GJ, DAS M, Bonnett LJ, Hall MCS, Snowdon RL, Waktare JEP, Modi S, Todd DM, Gupta D. A novel marker to predict early recurrence after atrial fibrillation ablation: the ablation effectiveness quotient. J Cardiovasc Electrophysiol. 2015 Apr;26(4):397-403. doi: 10.1111/jce.12618. Epub 2015 Feb 25.
PubMed 25588685
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate Modification With Ablation and Antiarrhythmic Drugs in Non-Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01445925
- Acronym / sponsor ID
- SMAAN-PAF / LHCH901
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 4 Oct 2011 (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 investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Procedure: Pulmonary vein isolation (PVI), Drug: Pharmacological Substrate modificationPatients will undergo pulmonary venous isolation plus pharmacological substrate modification |
| Pulmonary vein isolation + Linear Lesions | Experimental | Procedure: Pulmonary vein isolation + linear lesions, Drug: Pharmacological Substrate modificationPatients will undergo pulmonary venous isolation plus both pharmacological and interventional substrate modification |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
- Non-paroxysmal atrial fibrillation, as pre-classified as
Key exclusion criteria (9 listed)
- Inability or unwillingness to receive oral anticoagulation with warfarin
- Previous Ablation procedure for AF
- Unwillingness or inability to complete the required follow up arrangements
- Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
- Documented typical atrial flutter
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 |
|---|---|---|
| Pulmonary vein isolation (PVI)Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm | Procedure or surgery | Pulmonary vein isolation |
| Pulmonary vein isolation + linear lesionsUsing a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres. | Procedure or surgery | Pulmonary vein isolation + Linear Lesions |
| Pharmacological Substrate modificationat least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post. | Drug | Pulmonary vein isolation, Pulmonary vein isolation + Linear Lesions |
Primary outcome
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure.
Time frame: 12 months
Defined as >30 sec of AF/ atrial tachycardia identified on ECG or ambulatory ECG monitoring following a 3 month blanking period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
- Derived from this study: PubMed 25588685Wynn GJ, DAS M, Bonnett LJ, Hall MCS, Snowdon RL, Waktare JEP, Modi S, Todd DM, Gupta D. A novel marker to predict early recurrence after atrial fibrillation ablation: the ablation effectiveness quotient. J Cardiovasc Electrophysiol. 2015 Apr;26(4):397-403. doi: 10.1111/jce.12618. Epub 2015 Feb 25.
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Atrial Fibrillation (AF)
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.
Dhiraj Gupta, MD DM MRCP principal investigator
Liverpool Heart and Chest Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation (PVI), Pulmonary vein isolation + linear lesions and Pharmacological Substrate modification in people with Atrial Fibrillation, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 2 sites 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 10 inclusion and 9 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 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial fibrillation/ atrial tachycardia at 6 months following a single procedure. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01445925, which also lists 1 linked publication.
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 22 Aug 2013.