NCT01713270

Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation

Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To study whether renal sympathetic denervation(RSD) is safe and effective in patients with drug-resistant hypertension and symptomatic atrial fibrillation.

Detailed description

Atrial fibrillation(AF) is the most common arrhythmia, and its frequency increases with age. Hemodynamic impairment and thromboembolic events related to AF result in significant morbidity, mortality, and cost. Management of patients with AF involves 3 objectives-correction of the rhythm disturbance, rate control, and prevention of thromboembolism. Regardless of whether the rate-control or rhythm-control strategy is pursued, attention must also be directed to antithrombotic therapy for prevention of thromboembolism. Pharmacological cardioversion approaches appear simple but are less efficacious. The major risk is related to poor tolerance of side effects，drug-associated toxicity，and proarrhythmic potentia1 of antiarrhythmic drugs. Radiofrequency catheter ablation of AF has developed rapidly in recent years, but the number of AF recurrences during the long-term follow-up was significant. In addition, the complications associated with AF ablation procedures likely to result in prolonged hospitalization, long-term disability or death. Hypertension is the most important risk factor for AF , Hypertension is associated with left ventricular hypertrophy, impaired ventricular filling, left atrial enlargement, and slowing of atrial conduction velocity. These changes in cardiac structure and physiology favor the development and maintenance of AF, and they increase the risk of thromboembolic complications. In patients with AF, aggressive treatment of hypertension may reverse the structural changes in the heart, reduce thromboembolic complications, and retard or prevent the occurrence of AF. Recently, many clinical researches have verified that Catheter-based renal sympathetic denervation can safely be used to substantially reduce blood pressure, reduce left ventricular hypertrophy, improve glucose tolerance and sleep apnea severity. Simultaneously, a marked reduction in muscle and whole-body sympathetic-nerve activity(MSNA) is apparent, with a decrease in renal and whole-body norepinephrine spillover. Left ventricle hypertrophy, left atrial enlargement, high norepinephrine level，glucose tolerance abnormity and obstructive sleep apnea are all recognized as independent risk factors for the development and recurrence of AF. So, we design this randomized parallel control multi center clinical study to demonstrate whether renal sympathetic denervation is safe and effective in patients with hypertension and symptomatic atrial fibrillation.

Conditions

• Hypertension
• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	renal sympathetic denervation	Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool, Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About four to eight ablations at 10 W for 1 minute each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
DRUG	drug	Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone
PROCEDURE	Direct-Current Cardioversion	After renal sympathetic denervation, Persistent AF individual (except intracardiac thrombus) accept Direct-Current Cardioversion within one week. anticoagulation (INR 2.0 to 3.0) is recommended for at least 3 weeks prior to and 4 weeks after cardioversion.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2015-07-01
• First posted: 2012-10-24
• Last updated: 2013-07-08

Locations

1 site across 1 country: China