Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2015-05-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Atrial fibrillation ablation only
Atrial fibrillation ablation
Percutaneous catheter ablation for Atrial fibrillation.
ROX Coupler
Atrial fibrillation ablation with concurrent ROX Coupler insertion
Atrial fibrillation ablation
Percutaneous catheter ablation for Atrial fibrillation.
ROX Coupler insertion
The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
Interventions
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Atrial fibrillation ablation
Percutaneous catheter ablation for Atrial fibrillation.
ROX Coupler insertion
The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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Neil Sulke
OTHER
Responsible Party
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Neil Sulke
Consultant Cardiologist
Principal Investigators
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Neil Sulke, DM
Role: PRINCIPAL_INVESTIGATOR
East Sussex healthcare NHS trust
Locations
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Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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LAAPITUP3
Identifier Type: -
Identifier Source: org_study_id
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