Combined Treatment of Arterial Hypertension and Atrial Fibrillation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01897545
• Date of registration: 03/07/2013
• Prospective Registration: No
• Primary sponsor: Meshalkin Research Institute of Pathology of Circulation
• Public title: Combined Treatment of Arterial Hypertension and Atrial Fibrillation
• Scientific title: The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Atrial Fibrillation and Arterial Hypertension
• Date of first enrolment: April 2012
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01897545
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Greece, Russian Federation, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Symptomatic drug-refractory AF (with history of failure of =2 class I or III
antiarrhythmic drugs) in patients referred for catheter ablation of AF

- PAF with =1 monthly episodes or PersAF in patients who had already undergone =3
electrical cardioversions. PAF was defined as episodes lasting less than 7 days with
spontaneous termination. PersAF was defined as lasting more than 7 days before being
terminated pharmacologically or by electrical cardioversion.

- Office-based systolic blood pressure of =140/90 mm Hg, despite treatment with 3
antihypertensive drugs (including 1 diuretic)

- A glomerular filtration rate =45 mL/min/1·73 m2, with modification of diet using a
renal disease formula

Exclusion Criteria:

- Secondary causes of hypertension

- Severe renal artery stenosis or dual renal arteries

- Congestive heart failure with NYHA II-IV symptoms

- Left ventricular ejection fraction <35%

- Transverse left atrial diameter > 60 mm on transthoracic echocardiography

1. Previous AF ablation procedure

2. Treatment with amiodarone

- Previous renal artery stenting or angioplasty

- Type 1 diabetes mellitus



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arterial Hypertension

Atrial Fibrillation

Intervention(s)

Procedure: PV isolation+renal denervation

Procedure: Circumferential PV isolation

Primary Outcome(s)

recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug [Time Frame: 1 year]

Secondary Outcome(s)

office blood pressure [Time Frame: 1 year]

safety data before and at 3, 6, 9, and 12 months after procedure [Time Frame: 1 year]

Secondary ID(s)

RDAFA-030

Source(s) of Monetary Support

Please refer to primary and secondary sponsors