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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01959997

Enrollment

Registered

2013-10-10

Start date

2013-09-30

Completion date

2016-09-30

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Atrial Fibrillation

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.

Interventions

PROCEDURERedo PVI

PROCEDUREPVI + RDN

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Russia, United States

Contacts

Primary ContactEvgeny Pokushalov, MD, PhD

e.pokushalov@gmail.com+79139254858

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026