Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Pr… (NCT03511313) | Clinical Trial Compass
UnknownNot Applicable
Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
China264 participantsStarted 2018-04-11
Plain-language summary
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individual is ≥18 years and ≤65 years old.
* Primary hypertension.
* Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and\<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and \<170mmHg at the fourth week after screening.
Exclusion Criteria:
* Secondary hypertension.
* History of prior renal artery intervention including balloon angioplasty or stenting.
* Renal artery stenosis (≥50%) in either renal artery.
* Main renal arteries with \<4mm, or \>8mm in diameter.
* Main renal arteries with \<20mm in length.
* Estimated glomerular filtration rate (eGFR) of \<40 ml/(min•1.73m2).
* History of Stroke or TIA within 6 months prior to screening period.
* History of Acute coronary syndrome within 6 months prior to screening period.
* Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and o…
What they're measuring
1
Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
Timeframe: from baseline to 3 months post-procedure