Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation

NCT01814111 | Unknown DMC

• 1 other identifier: 2012-SR-082
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Atrial Fibrillation

Keywords

Hypertension; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Change in atrial fibrillation burden

  The primary endpoint of this study is the Change in atrial fibrillation burden, atrial fibrillation burden was calculated as the median number of minutes in AF over a 24-hour period for each Holter recording

  baseline and 12 months

Secondary Outcomes (6)

• change in blood pressure

  baseline and 12 months

• Cardiac function and structure

  baseline and 12 months

• heart-rate-variability

  baseline and 12 months

• pulse wave velocity

  baseline and 12 months

• life quality on SF-36 Health Survey Questionnaire

  baseline and 12 months

Study Arms (2)

renal sympathetic denervation

EXPERIMENTAL

Perform renal angiogram immediately prior to renal sympathetic denervation procedure to confirm anatomic eligibility，The treatment catheter was introduced into each renal artery using a guiding catheter. Up to six ablations at 10 W for 1 min each were performed in both renal arteries. Treatments were delivered from the first distal main renal artery bifurcation to the ostium proximally and were spaced longitudinally and rotationally under fluoroscopic guidance. Catheter tip impedance and temperature were constantly monitored, and radio frequency energy delivery was regulated according to a predetermined algorithm. Visceral pain at the time of energy delivery was managed with intravenous analgetics and sedatives.

Procedure: renal sympathetic denervation

Drug Treatment Group

NO INTERVENTION

All the patients in this group will take their baseline antihypertensive medication at the original doses, without any changes except when medically required. AAD treatment is consistent in both arms.

Interventions

renal sympathetic denervation PROCEDURE

The ablation catheter was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis.

renal sympathetic denervation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• qijun shan, Professor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor，protomedicus and tutor for doctor in cardiovascular department

Study Record Dates

• First Submitted: March 13, 2013
• First Posted: March 19, 2013
• Study Start: July 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

CN (1)