Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-03 @ 11:44 PM
Study NCT ID:
NCT05743894
Status:
UNKNOWN
Last Update Posted:
2023-02-24
First Post:
2023-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RDN Fesibility Study
Sponsor:
Chinese University of Hong Kong
Organization:
Study Overview
Official Title:
Renal Nerve Simulation Guided Renal Sympathetic Denervation With Siymplicity Spyral Radiofrequency Catheter for Resistant Hypertension: a Feasibility Study.
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively disabling the nerves around the renal arteries and reducing blood pressure increase. However, despite the early success showed in the SYMPLICITY HTN-2 trial, the SYMPLICITY HTN-3 trial failed to demonstrate a significant BP reduction when compared to sham-control. incomplete disabling might result in inadequate denervation and were cited as some of the contributors to the nil result in the SYMPLICITY HTN-3 . The new generation of the Symplicity Spyral catheter aims to address some of these issues by altering the configuration of the catheter to allow better apposition to the renal arterial wall and increasing the numbers of electrodes to faciiitate more thorough ablations. However, the adequacy of sympathetic denervation with this new catheter can not be easily assessed at the time of the procedure as there is no simple physiological or biochemical feedbacks that can be monitored during the procedure. Blood pressure response by renal nerve simulation (RNS) during RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the efficacy during the procedure and predict the BP response 6 months after RDN. The feasibility of RNS guided RDN procedure using the new generation of Symplicity Spyral catheter has not been reported. We therefore aim to explore the feasibility of RNS guided RDN with Symplicity Spyral Radiofrequency Catheter in patient with resistant hypertension.
Detailed Description:
Renal sympathetic denervation (RDN) was considered an effective alternative for patients whose blood pressure (BP) is not optimally controlled. The RDN works mainly by selectively disabling the nerves around the renal arteries and reducing blood pressure increase. However, despite the early success showed in the SYMPLICITY HTN-2 trial, the SYMPLICITY HTN-3 trial failed to demonstrate a significant BP reduction when compared to sham-control. incomplete disabling might result in inadequate denervation and were cited as some of the contributors to the nil result in the SYMPLICITY HTN-3 . The new generation of the Symplicity Spyral catheter aims to address some of these issues by altering the configuration of the catheter to allow better apposition to the renal arterial wall and increasing the numbers of electrodes to faciiitate more thorough ablations. However, the adequacy of sympathetic denervation with this new catheter can not be easily assessed at the time of the procedure as there is no simple physiological or biochemical feedbacks that can be monitored during the procedure. Blood pressure response by renal nerve simulation (RNS) during RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the efficacy during the procedure and predict the BP response 6 months after RDN. The feasibility of RNS guided RDN procedure using the new generation of Symplicity Spyral catheter has not been reported. We therefore aim to explore the feasibility of RNS guided RDN with Symplicity Spyral Radiofrequency Catheter in patient with resistant hypertension.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: