- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243891
AF Ablation With or Without ROX Coupler Study (LAAPITUP3)
March 8, 2015 updated by: Neil Sulke
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
East Sussex
-
Eastbourne, East Sussex, United Kingdom, BN21 2UD
- Eastbourne District General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
- Peak RER > 1.0 on Cardiopulmonary exercise testing
- Age over 18 years old.
- Informed consent to participate in this study.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Atrial fibrillation ablation only
|
Percutaneous catheter ablation for Atrial fibrillation.
|
Experimental: ROX Coupler
Atrial fibrillation ablation with concurrent ROX Coupler insertion
|
Percutaneous catheter ablation for Atrial fibrillation.
The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AF ablation success
Time Frame: 3 months
|
No AF burden detected on implantable loop recorder
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Sulke, DM, East Sussex Healthcare Nhs Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
October 1, 2017
Study Registration Dates
First Submitted
September 16, 2014
First Submitted That Met QC Criteria
September 16, 2014
First Posted (Estimate)
September 18, 2014
Study Record Updates
Last Update Posted (Estimate)
March 10, 2015
Last Update Submitted That Met QC Criteria
March 8, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LAAPITUP3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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