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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Atrial Fibrillation; Arterial Hypertension

Treatments: Procedure: PVI + RDN; Procedure: Redo PVI

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01959997

RD_REDO_032

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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:

  1. Inability to access renal vasculature
  2. Main renal arteries < 4 mm in diameter or < 20 mm in length.
  3. Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery
  4. A history of prior renal artery intervention including balloon angioplasty or stenting that precludes a possibility of ablation treatment
  5. Multiple main renal arteries to either kidney

• Unwillingness to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Redo PVI

Active Comparator group

Description:

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.

Treatment:

Procedure: Redo PVI

PVI + RDN

Active Comparator group

Description:

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.

Treatment:

Procedure: PVI + RDN