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

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Arterial Hypertension
• Intervention / Treatment: Procedure: Redo PVI; Procedure: PVI + RDN

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • State Research Institute of Circulation Pathology
• United States
  • New York
    • Rochester, New York, United States
      • Active, not recruiting
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Redo PVI; 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
Active Comparator: PVI + RDN; 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

What is the study measuring?

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	Time Frame
Systolic and diastolic blood pressures	1 year
procedural duration and complications	1 year
LV mass on echocardiogram	1 year

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Principal Investigator: Jonathan S. Steinberg, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: RD_REDO_032