Full Length Versus Proximal Renal Arteries Ablation

The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation

Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.

Study Overview

• Status: Completed
• Conditions: Hypertension, Resistant to Conventional Therapy
• Intervention / Treatment: Device: Thermocool®Rcatheter; Device: Thermocool®Rcatheter

Detailed Description

After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • 2ndChongqingMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• office systolic blood pressure of 160 mm Hg or more,
• patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
• Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
• ≥ 18 years old,;
• did not have any known secondary cause of hypertension;
• had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.

Exclusion Criteria:

• patients with type 1 diabetes,
• implanted pacemakers or implantable cardioverter defibrillators;
• pregnant women;
• haemodynamically significant valvular disease;
• patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Group 1 received ablation from distal to ostial of bilateral renal arteries	Device: Thermocool®Rcatheter; The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter; Device: Thermocool®Rcatheter; The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter
Experimental: Group 2; group 2 received ablation at proximal of bilateral renal arteries	Device: Thermocool®Rcatheter; The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter; Device: Thermocool®Rcatheter; The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	office BP and Ambulatory blood pressure	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ablation-related complications	ablation-related complications such as pseudoaneurysm，renal artery injury	one year

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 6, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Hypertension; Coronary Vasospasm
• Other Study ID Numbers: SWAN- RDN Strategy