At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
Covidien OneShot™ Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot™ Ablation System
In Brief
A clinical study evaluating Covidien OneShot™ System for Hypertension, Resistant to Conventional Therapy. Completed, enrolled 50 participants across 14 sites in 6 countries.
Detailed Summary
The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Italy, Luxembourg, Netherlands, New Zealand
CollaboratorsMedtronic - MITG, Meditrial Europe Ltd.
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 2012
Enrollment StartMay 2012
Primary CompletionNov 2013
Study CompletionJun 2014
TodayJul 2026
First PostedJan 30, 2012
Enrollment StartMay 1, 2012
Primary CompletionNov 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 14.4 years ago
Interventions
Covidien OneShot™ Systemdevice
Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.