RDN Fesibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-21

Study Completion Date

2023-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

NCT01888315

Hypertension Heart Failure Chronic Kidney Disease +2 more

UNKNOWN PHASE1/PHASE2

Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure

NCT06235554

Essential Hypertension

NOT_YET_RECRUITING NA

Changes in Skin Conductance Measurement as an Endpoint Monitor for Sympathetic Blocks

NCT02390323

Nerve; Disorder, Sympathetic

COMPLETED NA

Endovascular Denervation in Patients With Cancer Pain

NCT03431922

Cancer Pain

UNKNOWN NA

Renal Sympathetic Denervation and Insulin Sensitivity (RENSYMPIS Study)

NCT01785732

Resistant Hypertension

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Renal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Symplicity Spyral RENAL DENERVATION (RDN) SYSTEMTM Livewire™ Reflexion™ Catheter

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 ablating the sympathetic fibres around the renal arteries and damping the sympathetic overdrive. Blood pressure response by renal nerve stimulation (RNS) during the RDN procedure using the previous generation of the Symplicity Flex catheter have been reported to be potential parameter to assess the intra-procedure efficacy and predict the BP response 6 months after RDN

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age \> 18 years
2. With resistant hypertension as defined by systolic BP over 140 mmHg on 24 hours ambulatory blood pressure measurement (ABPM)
3. Already on a stable dose of at least 3 anti-hypertensive drugs of different classes for 3 months.
4. subject is recruited for Transcatheter Renal Denervation

Exclusion Criteria

1. Individual has undergone prior renal denervation.
2. Presence of renal artery stenosis \>50%.
3. Main renal artery diameter \<3mm and larger than 8mm by visual assessment on angiography.
4. Previous renal stenting.
5. Subject with Estimated GFR \<30ml/min/1.73m2 as calculated using the MDRD formula.
6. Subject with renal transplant, single kidney, active nephritis or polycystic kidney disease.
7. Subject with known pheochromocytoma, Cushing's Syndrome (hypercortisolism), primary hyperaldosteronism, coarctation of the aorta, untreated hyperthyroidism, untreated hypothyroidism, or primary hyperparathyroidism.
8. Subject with unstable cardiac conditions such as myocardial infarction, unstable angina, malignant arrythmia, pulmonary embolism, significant valvular condition awaiting surgery or recent cerebrovascular accident within 3 months of recruitment.
9. Subject who is pregnant or planning for pregnancy during the study duration.
10. Subject who is enrolled in another device study for renal sympathetic denervation.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No