Hypertension Clinical Trial
— LAAPITUP3Official 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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | October 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Eastbourne District General Hospital | Eastbourne | East Sussex |
Lead Sponsor | Collaborator |
---|---|
Neil Sulke |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AF ablation success | No AF burden detected on implantable loop recorder | 3 months | No |
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