AF Ablation With or Without ROX Coupler Study (LAAPITUP3)

This is an interventional treatment trial for Atrial Fibrillation Read More

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.