Renal Sympathetic Denervation in Patients With Hypertension and Paroxysmal Atrial Fibrillation (RSDforPAF)
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|ClinicalTrials.gov Identifier: NCT01814111|
Recruitment Status : Unknown
Verified March 2013 by Qijun Shan, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : March 19, 2013
Last Update Posted : March 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Atrial Fibrillation||Procedure: renal sympathetic denervation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Safety and Effectiveness Study of Percutaneous Catheter-based Sympathetic Denervation of the Renal Arteries in Patients With Hypertension and Paroxysmal Atrial Fibrillation|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||June 2015|
Experimental: renal sympathetic denervation
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
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.
No Intervention: Drug Treatment Group
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.
- Change in atrial fibrillation burden [ Time Frame: baseline and 12 months ]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
- change in blood pressure [ Time Frame: baseline and 12 months ]change in Office systolic and diastolic blood pressure,
- Cardiac function and structure [ Time Frame: baseline and 12 months ]measure left ventricular ejection fractionleft，left ventricular end diastolic diameter, ventricular septal thickness, left atrium diameter by echocardiographic
- heart-rate-variability [ Time Frame: baseline and 12 months ]heart-rate-variability by Holter
- pulse wave velocity [ Time Frame: baseline and 12 months ]
- life quality on SF-36 Health Survey Questionnaire [ Time Frame: baseline and 12 months ]
- Blood biochemical examination Blood biochemical examination Blood biochemical examination [ Time Frame: baseline and 12 months ]include Fasting blood glucose, Glycated hemoglobin，Urinary protein
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814111
|First Affiliated Hospital of Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: qijun shan, professor 0086 025 68136407 firstname.lastname@example.org|
|Principal Investigator: qijun shan, professor|
|Study Chair:||qijun shan, Professor||The First Affiliated Hospital with Nanjing Medical University|