Paroxysmal Atrial FibrillationPhase 4LAAPITUP 2NCT01504451
Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study: The LAAPITUP 2 Study
A Phase 4 study testing ILR insertion and AF ablation in people with Paroxysmal Atrial Fibrillation, run by Neil Sulke at 2 sites in United Kingdom.
Trial summary
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- ILR insertion and AF ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2012to May 2015
- Phase
- Phase 4
- 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
- Symptomatic paroxysmal AF suitable for AF ablation
- Age > 18 years old
- Informed consent to participate in this study.
Who cannot join
- Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
- Unable to undergo general anaesthesia for AF ablation.
- Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
- Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
- Previous thoracic surgery.
- Participation in a conflicting study.
Show all 9Show fewer
- Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
- Pregnancy
- Other cardiac rhythm disorders
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal Sussex County Hospital
Brighton, Sussex, BN2 5BE
Eastbourne General Hospital
Eastbourne, E Sussex, BN21 2UD
About this study
Official title: Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
Read the detailed description
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- ILR insertion, AF ablation
- Keywords
- Atrial fibrillation, Ablation, Implantable loop recorder
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILR insertionDevice
Insertion of implantable loop recorder
AF ablationProcedure or surgery
AF ablation
| Study group | Role | What they receive |
|---|---|---|
| Biosense Webster ablation | Active comparator | Biosense Webster irrigated multi-electrode phased radiofrequency AF ablation Receives: Device: ILR insertion; Procedure: AF ablation |
| Surgical ablation | Active comparator | Minimally invasive thoracoscopic surgical AF ablation Receives: Device: ILR insertion; Procedure: AF ablation |
| Medtronic ablation | Active comparator | Medtronic multi-electrode phased radiofrequency AF ablation Receives: Device: ILR insertion; Procedure: AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden
Total proportion of time spent in AF as assessed by ILR
Measured: 12 months after ablation
Secondary outcomes (3)
Time to AF recurrence
Time to recurrence of any AF after ablation
Measured: Up to one year
Time to first symptomatic AF recurrence
Time to first symptomatic AF recurrence as assessed by ILR.
Measured: Up to one year
Change in QoL measures
Change in Quality of Life measures assessed by questionnaire.
Measured: 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2015 (estimated)
- Study completionMay 2015 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neil Sulke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neil Sulke, East Sussex Healthcare NHS Trust
- Investigators
- Neil Sulke, MD, Principal investigator, East Sussex Healthcare NHS TrustStephen S Furniss, MD, Principal investigator, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504451
- Sponsor's protocol ID
- LAAPITUP 2
- Acronym
- LAAPITUP 2
- Status last verified
- Jun 2014
- First submitted
- 30 Dec 2011
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.
PubMed 29092038
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Ablation of Paroxysmal Atrial Fibrillation With Implantable Loop Recorder Follow Up Study 2
- ClinicalTrials.gov ID
- NCT01504451
- Acronym / sponsor ID
- LAAPITUP 2 / LAAPITUP 2
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation, Implantable loop recorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Neil SulkeUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 5 Jan 2012 (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.
This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
Detailed description
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biosense Webster ablation | Active comparator | Device: ILR insertion, Procedure: AF ablationBiosense Webster irrigated multi-electrode phased radiofrequency AF ablation |
| Surgical ablation | Active comparator | Device: ILR insertion, Procedure: AF ablationMinimally invasive thoracoscopic surgical AF ablation |
| Medtronic ablation | Active comparator | Device: ILR insertion, Procedure: AF ablationMedtronic multi-electrode phased radiofrequency AF ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic paroxysmal AF suitable for AF ablation
- Age > 18 years old
- Informed consent to participate in this study.
Key exclusion criteria (9 listed)
- Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
- Unable to undergo general anaesthesia for AF ablation.
- Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
- Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
- Previous thoracic surgery.
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 |
|---|---|---|
| ILR insertionInsertion of implantable loop recorder | Device | Biosense Webster ablation, Medtronic ablation, Surgical ablation |
| AF ablationAF ablation | Procedure or surgery | Biosense Webster ablation, Medtronic ablation, Surgical ablation |
Primary outcome
AF burden
Time frame: 12 months after ablation
Total proportion of time spent in AF as assessed by ILR
3 secondary outcomes
Time to AF recurrence
Time frame: Up to one year
Time to first symptomatic AF recurrence
Time frame: Up to one year
Change in QoL measures
Time frame: 12 months after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
- Derived from this study: PubMed 29092038Sugihara C, Furniss S, Hyde J, Lewis M, Sulke N. Results of the first investigator-initiated randomized clinical trial of nMARQTM, PVACTM, and thoracoscopic ablation for paroxysmal atrial fibrillation. Europace. 2018 Nov 1;20(FI_3):f384-f391. doi: 10.1093/europace/eux267.
Related trials for Paroxysmal Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
Atrial Fibrillation
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Active, not recruiting
A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF
Atrial Fibrillation
Not yet recruitingObservational study
Catheter Ablation Using a Novel Navigation and Imaging System
Paroxysmal 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.
Neil Sulke, MD principal investigator
East Sussex Healthcare NHS Trust
Stephen S Furniss, MD principal investigator
East Sussex Healthcare NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ILR insertion and AF ablation in people with Paroxysmal Atrial Fibrillation, run by Neil Sulke 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 3 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 26 Jun 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
AF burden (time frame: 12 months after ablation). 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 NCT01504451, 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 26 Jun 2014.