Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI

Study Overview
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Brief Summary
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The objective of this study is to compare the elimination of atrial fibrillation in patients with recurrent atrial fibrillation despite prior pulmonary vein isolation (PVI) when undergoing repeat PVI (control) vs repeat PVI plus renal denervation.

Official Title
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Randomized Comparison of Redo Pulmonary Vein Isolation With vs. Without Renal Denervation for Recurrent Atrial Fibrillation After Initial Pulmonary Vein Isolation

Conditions
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Atrial Fibrillation, Arterial Hypertension

Intervention / Treatment
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* Procedure: Redo PVI
* Procedure: PVI + RDN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prior PVI ablation procedure for paroxysmal AF within past 2 years Recurrent symptomatic paroxysmal AF despite prior PVI History of essential hypertension requiring at least 2 chronic antihypertensive medications Exclusion Criteria: Persistent AF after prior ablation Congestive heart failure (NYHA III-IV functional class) Left ventricle ejection fraction < 35% Left atrial diameter >55 mm An estimated glomerular filtration rate (eGFR) < 45mL/min/1.73m2, using the MDRD calculation Renal arteries unsuitable for RDN: Inability to access renal vasculature Main renal arteries < 4 mm in diameter or < 20 mm in length. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment Multiple main renal arteries to either kidney Unwillingness to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Redo PVI<br>Therapeutic anticoagulation will be required for at least 3 weeks prior to ablation. An MRA will be performed to define cardiac and PV anatomy. Standard ablation technique will be employed. After gaining venous access, double transseptal puncture will be performed to permit left atrial access, guided by intracardiac ultrasound. A circular mapping catheter will be placed in each PV and any reconnections will be ablated by delivery of RF energy. Confirmation of re-isolation of all PVs will be performed at the conclusion of the procedure. | Procedure: Redo PVI<br> <br> |
| Active Comparator: PVI + RDN<br>All patients who are randomized to Group II will undergo redo PVI exactly as described above. At the conclusion of PVI, RDN will be performed. Real-time 3-dimensional aorta-renal artery maps will be constructed with the use of the same navigation system and catheter used for PVI after femoral artery access. Both mapping and ablation will performed under the same modified sedation. RF ablations of 8 to 10 watts will be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium, for 2 min, and up to 6 lesions (separated by ≥ 5 mm). Lesions will be made both longitudinally and rotationally within each renal artery. To confirm renal denervation, high-frequency stimulation (HFS) will be used before the initial and after each RF delivery within the renal artery. RDN will be considered to have been achieved when the sudden increase of blood pressure (≥ 15 mm Hg from invasive arterial monitoring) is absent. | Procedure: PVI + RDN<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of AF | The absence of AF at one year as assessed by prolonged ambulatory ECG monitoring post-ablation after 3 month blanking period has expired following the repeat ablation procedure. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic and diastolic blood pressures |  | 1 year | 
| procedural duration and complications |  | 1 year | 
| LV mass on echocardiogram |  | 1 year |