NCT01117025CompletedPhase 2
The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension
Meshalkin Research Institute of Pathology of Circulation3 sites in 2 countries26 target enrollmentStarted: April 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- Freedom of AF or other atrial arrhythmias
Study Overview
Brief Summary
The purpose of this study is the comparative evaluation of systolic blood pressure (SBP) lowering, atrial fibrillation (AF) recurrence and clinical data in patients with paroxysmal/persistent AF and resistant hypertension, undergoing AF ablation alone or combined with percutaneous renal denervation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥160 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
- •Previous atrial fibrillation ablation
- •Type 1 of diabetes mellitus
- •Structural heart disease
- •Secondary cause of atrial hypertension
- •Severe renal artery stenosis or renal arteries abnormalities
- •Previous operations on renal arteries
- •Pregnancy
- •Previous heart, kidney, liver, or lung transplantation
- •Unwillingness of participant
Outcomes
Primary Outcomes
Freedom of AF or other atrial arrhythmias
Time Frame: 1 year
Secondary Outcomes
- Systolic blood pressure lowering(1 year)
Investigators
Study Sites (3)
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