Nctid:
NCT06235554
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000075222", "term"=>"Essential Hypertension"}], "ancestors"=>[{"id"=>"D006973", "term"=>"Hypertension"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}], "browseLeaves"=>[{"id"=>"M10024", "name"=>"Hypertension", "relevance"=>"LOW"}, {"id"=>"M1470", "name"=>"Essential Hypertension", "asFound"=>"Essential Hypertension", "relevance"=>"HIGH"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP", "interventionModelDescription"=>"Feasibility study, prospective, open-label, single center, single-arm study"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-07-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"prevalence of occurrence of adverse events", "timeFrame"=>"Three month after procedure", "description"=>"safety of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure"}, {"measure"=>"efficacy on Systolic Blood Pressure change to be measured with a blood pressure monitor", "timeFrame"=>"Three month after procedure", "description"=>"efficacy of the renal nerves stimulation performed by Direct Wire Pacing technique during renal denervation procedure"}], "secondaryOutcomes"=>[{"measure"=>"Impact on Systolic Blood Pressure", "timeFrame"=>"Three month after procedure", "description"=>"Investigate the impact of the renal denervation in the Renal Nerves Stimulation induced Systolic Blood Pressure change."}, {"measure"=>"Systolic Blood Pressure as response prediction tool", "timeFrame"=>"Three month after procedure", "description"=>"Investigate whether Renal Nerves Stimulation induced Systolic Blood Pressure change before Renal Denervation could be a reliable tool to predict mid-term Renal Denervation response"}, {"measure"=>"Systolic Blood Pressure variation as response prediction tool", "timeFrame"=>"Three month after procedure", "description"=>"Investigate whether difference in Renal Nerves Stimulation-induced Systolic Blood Pressure change before and after Renal Denervation could be a reliable tool to predict mid-term Renal Denervation"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Renal Stimulation", "Renal Denervation procedure"], "conditions"=>["Essential Hypertension"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this feasibility study is to evaluate the safety and efficacy of the Renal Stimulation (RNS) by Direct Wire Pacing, during Renal Denervation (RDN) procedure in patient candidate for renal denervation with the ParadiseTM System. The main questions it aims to answer are:\n\n* Is the RNS before RDN a straightforward method, allowing quantification of the renal sympathetic traffic?\n* Does the RNS increase blood pressure (SBP), and is this increase significantly blunted after RDN?\n* Does the 3-month 24h SBP decrease correlated with the RNS-induced SBP change before RDN?\n* Can the difference between RNS-induced SBP rise before and after RDN be used as a procedural endpoint for RDN? Participants will be asked for their agreement to conduct an RNS before and after the RDN. No additional experimental procedure will be added to the standard of care."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patient willing and able to comply with the protocol and has provided written informed consent.\n* Age ≥18\n* Patient candidate for renal denervation with the ParadiseTM System based on physician's assessment.\n* Patients affiliated to a social security system\n\nExclusion Criteria:\n\n* Patients who meet any of the contraindications listed in the Instructions for Use of ParadiseTM Ultrasound Renal Denervation System will be excluded:\n\n * Renal arteries diameter \\< 3 mm and \\> 8 mm\n * Patient with relevant renal artery disease (% diameter stenosis \\> 30%, aneurysm or fibromuscular disease)\n * Stented renal artery\n * Iliac/femoral artery stenosis precluding insertion of the ParadiseTM catheter\n * Known allergy to contrast medium\n* Patient with known secondary cause of hypertension\n* Patient with contraindication to chronic anticoagulation therapy or heparin\n* Patient with Type 1 diabetes mellitus\n* Patient with more than one accessory renal artery\n* Woman currently pregnant or breastfeeding\n* Patient with other concomitant conditions that may adversely affect the patient or the study outcome\n* Patient with mental or physical inability to participate in the study\n* Patient under judicial protection, tutorship, or curatorship"}, "identificationModule"=>{"nctId"=>"NCT06235554", "acronym"=>"RNS by DWP", "briefTitle"=>"Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Ceric Sàrl"}, "officialTitle"=>"Feasibility Study Evaluating the Safety and Efficacy of the Renal Stimulation by Direct Wire Pacing, During Renal Denervation Procedure.", "orgStudyIdInfo"=>{"id"=>"2023-A01789-36"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"intervention", "interventionNames"=>["Procedure: Renal Stimulation"]}], "interventions"=>[{"name"=>"Renal Stimulation", "type"=>"PROCEDURE", "otherNames"=>["Renal Dernervation"], "description"=>"Renal Denervation procedure as per hospital routine practice", "armGroupLabels"=>["intervention"]}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Ceric Sàrl", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Electroducer", "class"=>"INDUSTRY"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
