Atrial FibrillationPhase 4ACTUALNCT01503268
Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study
A Phase 4 study testing Implantation of implantable loop recorder, Percutaneous ablation of atrial fibrillation and Surgical ablation of atrial fibrillation in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 2 sites in United Kingdom.
Trial summary
Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy. 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?
- Implantation of implantable loop recorder, Percutaneous ablation of atrial fibrillation and Surgical ablation of atrial fibrillation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Nov 2012to Nov 2014
- 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 persistent atrial fibrillation
- Age over 18 years
- Informed consent
Who cannot join
- Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI safe.
- Patients unable to undergo general anaesthesia for AF ablation.
- Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery
- Previous thoracic surgery
- Participation in a conflicting study
- 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, East Sussex, BN2 5BE
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD
About this study
Official title: Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders
Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy.
Ablation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall.
Read more
Because AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).
In this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Implantation of implantable loop recorder, Percutaneous ablation of atrial fibrillation, Surgical ablation of atrial fibrillation
- Keywords
- Atrial fibrillation, Ablation, Percutaneous ablation, Minimally-invasive thoracoscopic 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.
Implantation of implantable loop recorderDevice
An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.
Percutaneous ablation of atrial fibrillationProcedure or surgery
Catheter-based percutaneous ablation of atrial fibrillation
Surgical ablation of atrial fibrillationProcedure or surgery
Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous ablation | Active comparator | Not described Receives: Device: Implantation of implantable loop recorder; Procedure: Percutaneous ablation of atrial fibrillation |
| Surgical ablation | Active comparator | Not described Receives: Device: Implantation of implantable loop recorder; Procedure: Surgical ablation of atrial fibrillation |
| DCCV | Active comparator | Direct current cardioversion Receives: Device: Implantation of implantable loop recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in AF burden after ablation
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
Measured: One year
Time to recurrence of persistent AF
Measured: 1 year
Secondary outcomes (3)
Time to recurrence of atrial fibrillation after ablation
Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period
Measured: One year
Time to recurrence of symptomatic atrial fibrillation after ablation
Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period
Measured: One year
New MRI-detected subclinical cerebral ischaemia
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 posted4 Jan 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Why it stopped: Study methodology redesigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Sulke, East Sussex Healthcare NHS Trust
- Investigators
- A N Sulke, MD, Principal investigator, East Sussex Healthcare NHS TrustS S Furniss, MD, Principal investigator, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503268
- Sponsor's protocol ID
- ACTUAL 1.0
- Acronym
- ACTUAL
- Status last verified
- Jun 2013
- First submitted
- 30 Dec 2011
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders
- ClinicalTrials.gov ID
- NCT01503268
- Acronym / sponsor ID
- ACTUAL / ACTUAL 1.0
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation, Percutaneous ablation, Minimally-invasive thoracoscopic ablation, Implantable loop recorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study methodology redesigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 4 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.
Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy.
Ablation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall.
Because AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs).
In this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Percutaneous ablation | Active comparator | Device: Implantation of implantable loop recorder, Procedure: Percutaneous ablation of atrial fibrillation |
| Surgical ablation | Active comparator | Device: Implantation of implantable loop recorder, Procedure: Surgical ablation of atrial fibrillation |
| DCCV | Active comparator | Device: Implantation of implantable loop recorderDirect current cardioversion |
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 persistent atrial fibrillation
- Age over 18 years
- Informed consent
Key exclusion criteria (8 listed)
- Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI safe.
- Patients unable to undergo general anaesthesia for AF ablation.
- Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery
- Previous thoracic surgery
- Participation in a conflicting study
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 |
|---|---|---|
| Implantation of implantable loop recorderAn implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF. | Device | DCCV, Percutaneous ablation, Surgical ablation |
| Percutaneous ablation of atrial fibrillationCatheter-based percutaneous ablation of atrial fibrillation | Procedure or surgery | Percutaneous ablation |
| Surgical ablation of atrial fibrillationMinimally-invasive thoracoscopic surgical ablation of atrial fibrillation | Procedure or surgery | Surgical ablation |
Primary outcome
Reduction in AF burden after ablation
Time frame: One year
Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder
Time to recurrence of persistent AF
Time frame: 1 year
3 secondary outcomes
Time to recurrence of atrial fibrillation after ablation
Time frame: One year
Time to recurrence of symptomatic atrial fibrillation after ablation
Time frame: One year
New MRI-detected subclinical cerebral ischaemia
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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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.
A N Sulke, MD principal investigator
East Sussex Healthcare NHS Trust
S 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 Implantation of implantable loop recorder, Percutaneous ablation of atrial fibrillation and Surgical ablation of atrial fibrillation in people with Atrial Fibrillation, run by East Sussex Healthcare NHS 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 21 Jun 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in AF burden after ablation (time frame: One year). The study lists 2 primary outcomes in all. 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 21 Jun 2013.