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

Phase 2

• Conditions: Atrial Fibrillation; Arterial Hypertension

• Registration Number: NCT01959997
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The absence of AF	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

University of Rochester; 🇺🇸 Rochester, New York, United States

State Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation