Status:
UNKNOWN
AF Ablation With or Without ROX Coupler Study
Lead Sponsor:
Neil Sulke
Conditions:
Atrial Fibrillation
Hypertension
Eligibility:
All Genders
Phase:
PHASE4
Brief 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.
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 sympto...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02243891
Start Date
May 1 2015
End Date
October 1 2017
Last Update
March 10 2015
Active Locations (1)
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1
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom, BN21 2UD