Comparison of Redo PVI With vs. Without Renal Denervation for Recurrent AF After Initial PVI
Atrial Fibrillation, Arterial Hypertension
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- University of Rochester
- State Research Institute of Circulation PathologyRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Redo PVI
PVI + RDN
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.
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.