Atrial FibrillationPhase 4LAAPITUP3NCT02243891
AF Ablation With or Without ROX Coupler Study
A Phase 4 study testing Atrial fibrillation ablation and ROX Coupler insertion in people with Atrial Fibrillation and Hypertension, run by Neil Sulke at 1 site in United Kingdom.
Trial summary
The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in hypertensive subjects is more effective when a ROX coupler is inserted concurrently. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Hypertension
- What is being tested?
- Atrial fibrillation ablation and ROX Coupler insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Oct 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic paroxysmal AF suitable for AF ablation.
- Office Systolic blood pressure ≥ 140 mmHg based on an average of 3 blood pressure readings
- Ambulatory Blood Pressure Monitoring (ABPM) daytime average systolic blood pressure (SBP) ≥ 135 mmHg;
- Resistant Hypertension: Patients with established hypertension (diagnosed ≥ 12 months prior to baseline) and is on a guideline based drug regimen at a stable and a fully tolerated dose, consisting of ≥3 hypertensive medications (including 1 diuretic), or
- Uncontrolled Hypertension: Patient has drug intolerances to antihypertensive medications and is unable to take a guideline based drug regimen
- VO2 peak > 15mls/Kg/min on Cardiopulmonary exercise testing (CPX)
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- Peak RER > 1.0 on Cardiopulmonary exercise testing
- Age over 18 years old.
- Informed consent to participate in this study.
Who cannot join
- Secondary hypertension amenable to conventional therapy
- Left ventricular systolic dysfunction with EF < 50%
- E/E' > 15 on transthoracic echocardiography
- Uncontrolled diabetes.
- Body Mass Index > 40 kg/m2
- Contraindicated for treatment with an arteriovenous anastomosis or interventional vascular procedure
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- Severe chronic kidney disease as indicated by estimated glomerular filtration rate < 30 mL/min/1.73m2 using the MDRD calculation
- Renal denervation within the last 6 months
- Significant peripheral arterial and/or venous disease in the lower limbs (including unprovoked deep vein thrombosis, significant lower extremity edema and/or venous insufficiency)
- Current diagnosis of unstable cardiac disease requiring intervention,or significant history of serious cardiac comorbidity that may affect patient safety or study outcomes
- Current diagnosis of severe cerebrovascular disease or stroke within the past year
- Female patient who is pregnant, breastfeeding or planning to become pregnant; females of child-bearing potential must have a negative urine pregnancy test prior to treatment
- Any known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements
- Scheduled or planned surgery in the next 6 months that may affect patient safety or study outcomes
- Concurrent enrollment in another clinical trial without prior approval of ROX Medical, Inc.
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study
- Intolerant or allergic to all anti-thrombolytic medications including aspirin
- Pulmonary arterial hypertension (PAH) defined as mean pulmonary artery pressure (mPAP) >30 mmHg as measured by right heart catheterization
- Pulmonary capillary wedge pressure (PCWP) > 15mmHg as measured by right heart catheterization
- Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence.
- Participation in a conflicting study.
- Potential participants who are mentally incapacitated and cannot consent or comply with follow-up.
- Pregnancy.
- Other cardiac rhythm disorders.
- Severe aortic and mitral valve disease.
- Previous ROX coupler implantation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eastbourne District General Hospital
Eastbourne, East Sussex, BN21 2UD
About this study
Official title: Left Atrial Ablation for Paroxysmal Atrial Fibrillation and Hypertension With Implantable Loop Recorder With or Without ROX Coupler Follow Up Study: The LAAPITUP 3 Study
The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in hypertensive subjects is more effective when a ROX coupler is inserted concurrently.
Read the detailed description
The single blinded, randomised study is planned to commence in October 2014 after obtaining Research Ethics Committee and NHS Research and Development approval. A target of 20 participants with symptomatic paroxysmal AF will be recruited. All participants will be blinded and randomised to AF ablation only or AF ablation + ROX coupler implant. All participants will have right and left heart catheterisation prior to AF ablation +/- ROX coupler insertion. Participants will be followed up 6 weeks, 3, 6 months and 12 months after the ablation. The study will take place at Eastbourne District General. The study duration per patient is 13months. The overall study duration will be 18 months.
- Conditions
- Atrial Fibrillation, Hypertension
- Being tested
- Atrial fibrillation ablation, ROX Coupler insertion
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial fibrillation ablationProcedure or surgery
Percutaneous catheter ablation for Atrial fibrillation.
ROX Coupler insertionProcedure or surgery
The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Atrial fibrillation ablation only Receives: Procedure: Atrial fibrillation ablation |
| ROX Coupler | Experimental | Atrial fibrillation ablation with concurrent ROX Coupler insertion Receives: Procedure: Atrial fibrillation ablation; Procedure: ROX Coupler insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF ablation success
No AF burden detected on implantable loop recorder
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionOct 2017 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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, DM, Principal investigator, East Sussex Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243891
- Sponsor's protocol ID
- LAAPITUP3
- Acronym
- LAAPITUP3
- Status last verified
- Mar 2015
- First submitted
- 16 Sep 2014
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Ablation for Paroxysmal Atrial Fibrillation and Hypertension With Implantable Loop Recorder With or Without ROX Coupler Follow Up Study: The LAAPITUP 3 Study
- ClinicalTrials.gov ID
- NCT02243891
- Acronym / sponsor ID
- LAAPITUP3 / LAAPITUP3
- Conditions
- Atrial Fibrillation, Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Neil SulkeUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Sep 2014 (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 study will test the hypothesis that ablation of paroxysmal atrial fibrillation in hypertensive subjects is more effective when a ROX coupler is inserted concurrently.
Detailed description
The single blinded, randomised study is planned to commence in October 2014 after obtaining Research Ethics Committee and NHS Research and Development approval. A target of 20 participants with symptomatic paroxysmal AF will be recruited. All participants will be blinded and randomised to AF ablation only or AF ablation + ROX coupler implant. All participants will have right and left heart catheterisation prior to AF ablation +/- ROX coupler insertion. Participants will be followed up 6 weeks, 3, 6 months and 12 months after the ablation. The study will take place at Eastbourne District General. The study duration per patient is 13months. The overall study duration will be 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Atrial fibrillation ablationAtrial fibrillation ablation only |
| ROX Coupler | Experimental | Procedure: Atrial fibrillation ablation, Procedure: ROX Coupler insertionAtrial fibrillation ablation with concurrent ROX Coupler insertion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Symptomatic paroxysmal AF suitable for AF ablation.
- Office Systolic blood pressure ≥ 140 mmHg based on an average of 3 blood pressure readings
- Ambulatory Blood Pressure Monitoring (ABPM) daytime average systolic blood pressure (SBP) ≥ 135 mmHg;
- Resistant Hypertension: Patients with established hypertension (diagnosed ≥ 12 months prior to baseline) and is on a guideline based drug regimen at a stable and a fully tolerated dose, consisting of ≥3 hypertensive medications (including 1 diuretic), or
- Uncontrolled Hypertension: Patient has drug intolerances to antihypertensive medications and is unable to take a guideline based drug regimen
Key exclusion criteria (26 listed)
- Secondary hypertension amenable to conventional therapy
- Left ventricular systolic dysfunction with EF < 50%
- E/E' > 15 on transthoracic echocardiography
- Uncontrolled diabetes.
- Body Mass Index > 40 kg/m2
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 |
|---|---|---|
| Atrial fibrillation ablationPercutaneous catheter ablation for Atrial fibrillation. | Procedure or surgery | Control, ROX Coupler |
| ROX Coupler insertionThe ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula | Procedure or surgery | ROX Coupler |
Primary outcome
AF ablation success
Time frame: 3 months
No AF burden detected on implantable loop recorder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Neil Sulke, DM principal investigator
East Sussex Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrial fibrillation ablation and ROX Coupler insertion in people with Atrial Fibrillation and Hypertension, run by Neil Sulke 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 9 inclusion and 26 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 10 Mar 2015. 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.
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?
Contact Ragunath Shunmugam, M.B,B.S (+441323417400 ext. 4132, r.shunmugam@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF ablation success (time frame: 3 months). 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 10 Mar 2015; AzTrials last refreshed its copy on 27 Oct 2026.