Skip to content

Validation of a Novel Catheter-Based Renal Denervation System of Cryoablation in Patients with Resistant Hypertension: A First-in-man Study

Research of A Novel Catheter-Based Renal Denervation System of Cryoablation in Patients with Resistant Hypertension

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020545
Enrollment
Unknown
Registered
2019-01-07
Start date
2015-10-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Cryo-RDN Group:Renal denervation with cryoablation

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Participant aged 18 to 75 years old male and female; 2. Participant has an history of consecutive antihypertensive drugs taken with no alteration=2 weeks and agrees to remain for another 6 months; 3. Renal artery anatomy has the condition of Cryo-RDN; 4. Office SBP>140MM Hg with 3 measurements; 5. Participant agrees to cooperate with all study procedures performed and to provide written informed consent to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1. secondary hypertension; 2. 24h-sbp6mmol/L; 13. Participant has a significant bleeding tendency or blood system disease(s)(PLT1.5); 14. Participant is allergy to contrast; 15. Participant is pregnant, breast feeding or preparing to for pregnancy; 16. Participant is addicted to alcohol or other drugs or diagnosed with mental illness; 17. Participant has been enrolled in other drug or device clinical trials within 6 months; 18. Participant has other conditions inappropriate for participation, at the investigators discretion.

Design outcomes

Primary

MeasureTime frame
Office SBP;

Secondary

MeasureTime frame
Office DBP;24h-SBP;daytime-SBP;night-SBP;

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital, Fudan University

ge.junbo2@zs-hospital.sh.cn+86 13816005868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026