Full Length Versus Proximal Renal Arteries Ablation

NCT01848275 | Completed DMC

• 1 other identifier: SWAN- RDN Strategy
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension, Resistant to Conventional Therapy

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  office BP and Ambulatory blood pressure

  one year

Secondary Outcomes (1)

• ablation-related complications

  one year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Group 1 received ablation from distal to ostial of bilateral renal arteries

Device: Thermocool®Rcatheter

Group 2

EXPERIMENTAL

group 2 received ablation at proximal of bilateral renal arteries

Device: Thermocool®Rcatheter

Interventions

Thermocool®Rcatheter DEVICE

The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter

Group 1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

Location

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: March 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 17, 2017

Record last verified: 2017-07

Locations

CN (1)