Status:
UNKNOWN
Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Hypertension
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate whether renal sympathetic denervation is safe and effective in patients with hypertension and paroxysmal atrial fibrillation.
Detailed Description
Atrial fibrillation (AF) is one of the most common cardiac arrhythmia, complications of AF such as stroke, thromboembolism and heart failure will bring high disable rate and mortality , which will be ...
Eligibility Criteria
Inclusion
- Individual is ≥ 18 and ≤ 75 years of age.
- More than half a year for definite hypertension.
- AF is a common superventricular arrhythmia that is characterized by chaotic contraction of the atrium. An electrocardiogram (EGG) recording is necessary to diagnose AF. At least 30 seconds on a rhythm strip in an EGG record and at least 1 AF outbreak which was recorded by EGG and Holter in half a year.
- Paroxysmal AF Individual ,Paroxysmal AF is defined as recurrent AF (≧2 episodes) that terminates spontaneously within 7 days. Episodes of AF of ≤ 48 hours' duration that are terminated with electrical or pharmacologic cardioversion should also be classified as paroxysmal AF episodes.
- Individual eligible conditions through renal artery CTA inspection, such as undoubled renal artery on one side, renal artery length≧2cm, diameter≧4mm, and distortion at incept sect.
- Agree to attend clinic experiment and sign written informed consent.
Exclusion
- Persistent AF Individual, Persistent AF is defined as continuous AF that is sustained beyond seven days. Episodes of AF in which a decision is made to electrically or pharmacologically cardiovert the patient after \_≧48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
- Individual with Severely enlarged left atria≥ 55 mm
- Individual who reversibility mostly generated AF, such as abnormal hypothyroid or structural heart diseases
- Individual has experienced renal artery stenosis ，or A history of prior renal artery intervention including balloon angioplasty or stenting. or ineligible conditions through renal artery CTA inspection, such as double renal artery on one side, renal artery length≤2cm, diameter≤4mm, and distortion at incept sect.
- Individual has experienced a definite acute coronary syndrome in recent 3 months, or a cerebrovascular accident and alimentary canal bleeding within 3 months
- Individual has experienced sick sinus syndrome
- Pregnant Women or planning to be Pregnant Women, psychopathy Individual, individual who is sensitive to visualization, individual who can not cooperate with follow-up visit, or individual who researcher think it unsuitable to be included in this study
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01814111
Start Date
July 1 2012
End Date
June 1 2015
Last Update
March 19 2013
Active Locations (1)
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1
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000