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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01117025 |
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Date of registration:
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30/04/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Combined Treatment of Resistant Hypertension and Atrial Fibrillation
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Scientific title:
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The Role of Renal Denervation in Improving Outcomes of Catheter Ablation in Patients With Refractory Symptomatic Atrial Fibrillation and Resistant Hypertension |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01117025 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Greece
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Russian Federation
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United States
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Contacts
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Name:
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Evgeny A Pokushalov, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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State Research Institute of Circulation Pathology |
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Key inclusion & exclusion criteria
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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/1ยท73 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Atrial Fibrillation
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Hypertension, Resistant to Conventional Therapy
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Intervention(s)
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Procedure: Circumferential PV isolation
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Procedure: Circumferential PVI+renal denervation
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Primary Outcome(s)
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Freedom of AF or other atrial arrhythmias
[Time Frame: 1 year]
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Secondary Outcome(s)
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Systolic blood pressure lowering
[Time Frame: 1 year]
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Secondary ID(s)
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RU MC 001
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RDAFA-029
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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