AF Ablation With or Without ROX Coupler Study

Launched by NEIL SULKE · Sep 16, 2014

Keywords

ClinConnect Summary

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 Gen...

Gender

ALL

Eligibility criteria

• 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.