Paroxysmal Atrial FibrillationLAAPITUPNCT01095770
Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
A study testing AF Ablation with Ablation Frontiers Technology, AF Ablation with LASSO catheter and Reveal XT in people with Paroxysmal Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is 3 fold:- 1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF. 2. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- AF Ablation with Ablation Frontiers Technology, AF Ablation with LASSO catheter and Reveal XT
- Type of treatment
- Medical device, 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
- Apr 2010to Nov 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient aged 16-80 years old.
- Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
- PAF should have failed at least one drug therapy medical therapy.
- Patients must give written 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 mentally incapacitated and cannot consent or comply with follow-up.
- Patient has NYHA class III/ IV heart failure.
Show all 10Show fewer
- Patients with severe valvular or ventricular dysfunction.
- 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
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD
Steven J Podd, MBBS, MA, MRCP, 01323 417400 ext. 4132, steven.podd@esht.nhs.uk
Steven J Podd, MBBS, MA, MRCP
About this study
The purpose of this study is 3 fold:-
- To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF.
- To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
- To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- AF Ablation with Ablation Frontiers Technology, AF Ablation with LASSO catheter, Reveal XT, Permanent Dual Chamber Pacemaker
- Keywords
- Atrial Fibrillation, Atrial Fibrillation Ablation, Atrial Fibrillation monitoring, Ablation Frontiers, Reveal XT, LASSO
- 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 with Ablation Frontiers TechnologyProcedure or surgery
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
AF Ablation with LASSO catheterProcedure or surgery
AF Ablation with traditional LASSO catheter
Reveal XTDevice
Reveal XT implantable loop recorder monitored group
Permanent Dual Chamber PacemakerDevice
This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
| Study group | Role | What they receive |
|---|---|---|
| Ablation Frontiers Ablation | Active comparator | This group will undergo AF ablation using Ablation Frontiers Technology. Receives: Procedure: AF Ablation with Ablation Frontiers Technology |
| LASSO ablation | Active comparator | This group will undergo atrial fibrillation ablation with traditional LASSO technology Receives: Procedure: AF Ablation with LASSO catheter |
| Reveal XT monitoring | Active comparator | This group will be monitored pre and post ablation using a Reveal XT implantable loop recorder. Receives: Device: Reveal XT |
| Permanent Pacemaker - dual chamber | Active comparator | This group will be monitored pre and post ablation with a dual chamber permanent pacemaker Receives: Device: Permanent Dual Chamber Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF Burden
AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
Measured: 12 Months
AF Burden
Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
Measured: 12 months
AF Burden detected
To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
Measured: 12 months
Secondary outcomes (5)
Arrhythmia frequency - symptomatic or asymptomatic.
Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters.
Measured: 12 months
Time to first episode of AF
Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
Measured: 12 months
Average AF duration
Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
Measured: 12 months
Time to persistent AF.
Time to persistent AF (atrial fibrillation episode lasting for 7 days)
Measured: 12 months
Average SR duration.
Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1.
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 posted30 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012 (estimated)
- Study completionNov 2012 (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 Paroxysmal 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
- Investigators
- Stephen S Furniss, FRCP, MD, Principal investigator, East Sussex NHS TrustAN Sulke, FRCP, MD, Principal investigator, East Sussex NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095770
- Sponsor's protocol ID
- LAAPITUP
- Acronym
- LAAPITUP
- Status last verified
- Mar 2010
- First submitted
- 29 Mar 2010
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Podd SJ, Sulke AN, Sugihara C, Furniss SS. Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial. J Interv Card Electrophysiol. 2015 Dec;44(3):257-64. doi: 10.1007/s10840-015-0042-0. Epub 2015 Aug 27.
PubMed 26310300
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Ablation With Permanent Pacemaker or ImplanTable Loop Recorder Follow-UP
- ClinicalTrials.gov ID
- NCT01095770
- Acronym / sponsor ID
- LAAPITUP / LAAPITUP
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Atrial Fibrillation Ablation, Atrial Fibrillation monitoring, Ablation Frontiers, Reveal XT, LASSO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 30 Mar 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 this study is 3 fold:-
- To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF.
- To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
- To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ablation Frontiers Ablation | Active comparator | Procedure: AF Ablation with Ablation Frontiers TechnologyThis group will undergo AF ablation using Ablation Frontiers Technology. |
| LASSO ablation | Active comparator | Procedure: AF Ablation with LASSO catheterThis group will undergo atrial fibrillation ablation with traditional LASSO technology |
| Reveal XT monitoring | Active comparator | Device: Reveal XTThis group will be monitored pre and post ablation using a Reveal XT implantable loop recorder. |
| Permanent Pacemaker - dual chamber | Active comparator | Device: Permanent Dual Chamber PacemakerThis group will be monitored pre and post ablation with a dual chamber permanent pacemaker |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 16-80 years old.
- Symptomatic PAF with AF episodes self terminating after at least 30 seconds but not longer than 24 hours. Preference is given to patients with AF episodes lasting no longer than 4 hours.
- PAF should have failed at least one drug therapy medical therapy.
- Patients must give written informed consent form prior to participating in this study.
Key exclusion criteria (10 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 mentally incapacitated and cannot consent or comply with follow-up.
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 with Ablation Frontiers TechnologyAF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC. | Procedure or surgery | Ablation Frontiers Ablation |
| AF Ablation with LASSO catheterAF Ablation with traditional LASSO catheter | Procedure or surgery | LASSO ablation |
| Reveal XTReveal XT implantable loop recorder monitored group | Device | Reveal XT monitoring |
| Permanent Dual Chamber PacemakerThis group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities. | Device | Permanent Pacemaker - dual chamber |
Primary outcome
AF Burden
Time frame: 12 Months
AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
AF Burden
Time frame: 12 months
Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
AF Burden detected
Time frame: 12 months
To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
5 secondary outcomes
Arrhythmia frequency - symptomatic or asymptomatic.
Time frame: 12 months
Time to first episode of AF
Time frame: 12 months
Average AF duration
Time frame: 12 months
Time to persistent AF.
Time frame: 12 months
Average SR duration.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
- Derived from this study: PubMed 26310300Podd SJ, Sulke AN, Sugihara C, Furniss SS. Phased multipolar radiofrequency pulmonary vein isolation is as effective and safe as conventional irrigated point-to-point ablation. A prospective randomised 1-year implantable cardiac monitoring device follow-up trial. J Interv Card Electrophysiol. 2015 Dec;44(3):257-64. doi: 10.1007/s10840-015-0042-0. Epub 2015 Aug 27.
Related trials for Paroxysmal Atrial Fibrillation
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Recruiting
Evaluation of the FARAFLEX Mapping and Pulsed Field Ablation System in Subjects With Atrial Fibrillation
Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation
Not yet recruiting
A Global Randomized Trial Evaluating the FARAFLEX™ Mapping and Pulsed Field Ablation System With Electrographic Flow Mapping in Patients Undergoing Repeat Ablation for Atrial Fibrillation
Atrial Fibrillation (AF), Persistent Atrial Fibrillation (PersAF)
Recruiting
Feasibility Study of the FARAFLEX Mapping and PFA System
Atrial Fibrillation, Persistent Atrial Fibrillation
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.
Stephen S Furniss, FRCP, MD principal investigator
East Sussex NHS Trust
AN Sulke, FRCP, MD principal investigator
East Sussex NHS Trust
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 with Ablation Frontiers Technology, AF Ablation with LASSO catheter and Reveal XT in people with Paroxysmal 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 4 inclusion and 10 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 30 Mar 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, MRCP, BA (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?
AF Burden (time frame: 12 Months). The study lists 3 primary outcomes in all. 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 NCT01095770, 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 30 Mar 2010.