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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01959997
• Other study ID #: RD_REDO_032
• Status: Recruiting
• Phase: Phase 2
• First received: October 7, 2013
• Last updated: September 21, 2015
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Evgeny Pokushalov, MD, PhD
• Phone: +79139254858
• Email: e.pokushalov[@]gmail.com
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Hypertension
• Atrial Fibrillation
• Hypertension

Intervention

Procedure:
• Redo PVI

• PVI + RDN

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Pathology	Novosibirsk
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Countries where clinical trial is conducted

United States,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Systolic and diastolic blood pressures		1 year	No
Secondary	procedural duration and complications		1 year	Yes
Secondary	LV mass on echocardiogram		1 year	No