Search / Trial NCT06235554

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

Launched by CERIC SÀRL · Jan 22, 2024

Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Renal Stimulation Renal Denervation Procedure

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Patient willing and able to comply with the protocol and has provided written informed consent.
  • * Age ≥18
  • * Patient candidate for renal denervation with the ParadiseTM System based on physician's assessment.
  • * Patients affiliated to a social security system
  • Exclusion Criteria:
  • * Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:
  • * Renal arteries diameter \< 3 mm and \> 8 mm
  • * Patient with relevant renal artery disease (% diameter stenosis \> 30%, aneurysm or fibromuscular disease)
  • * Stented renal artery
  • * Iliac/femoral artery stenosis precluding insertion of the ParadiseTM catheter
  • * Known allergy to contrast medium
  • * Patient with known secondary cause of hypertension
  • * Patient with contraindication to chronic anticoagulation therapy or heparin
  • * Patient with Type 1 diabetes mellitus
  • * Patient with more than one accessory renal artery
  • * Woman currently pregnant or breastfeeding
  • * Patient with other concomitant conditions that may adversely affect the patient or the study outcome
  • * Patient with mental or physical inability to participate in the study
  • * Patient under judicial protection, tutorship, or curatorship

About Ceric Sàrl

Ceric sàrl is a clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Specializing in the design, management, and execution of clinical trials, Ceric sàrl focuses on delivering high-quality data to support the efficacy and safety of new therapeutic solutions. With a commitment to regulatory compliance and ethical standards, the company collaborates with a network of healthcare professionals and institutions to ensure robust trial methodologies and patient-centered approaches. Ceric sàrl is poised to contribute significantly to the advancement of medical science and improved patient outcomes.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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