Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Jie WANG, MD, PhD
CONTACT
JingJing ZHANG, BM
CONTACT
Lead
SyMap Medical (Suzhou), Ltd.
With
A. \*\*Prospective Study: \*\* In this cohort, the long-term safety and efficacy of the approved msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications. Study Period and Timeline (for A. Prospective Cohort)\*\* Subjects included in this post-market, real-world study will be followed for at least three years after msRDN procedure. The regarding clinical parameters will be taken at baseline and at each follow-up as below: * Visit 0: Baseline/Screening Period * Visit 1: msRDN procedure (Day 0) * Visit 2: 1 Month Post-msRDN (30 ± 7 days) * Visit 3: 3 Months Post-msRDN (90 ± 14 days) * Visit 4: 6 Months Post-msRDN (180 ± 30 days) * Visit 5: 12 Months Post-msRDN (360 ± 30 days) * Visit 6: 24 Months Post-msRDN (720 ± 30 days) * Visit 7: 36 Months Post-msRDN (1080 ± 30 days) B. \*\*Retrospective Study:\*\* In this cohort, the safety and efficacy of msRDN system will be evaluated in patients with drug-resistant hypertension or patients who are intolerant to drug therapy and, in either case, need to reduce antihypertensive medications, who have been treated by msRDN procedure. \*Study Period and Timeline (for B. Retrospective Cohort) \*\* Patients who have been consented and enrolled in the study will be followed for at least three years. In this cohort, as long as a patient meets inclusion criteria of the study and at least one clinical efficacy endpoint is recorded at ≥36 months after msRDN procedure, the data from this patient will be used for statistical analysis. During 36 month study period, data will be collected at baseline and at each follow-up point per protocol as below: * Visit 1: msRDN procedure (Day 0) * Visit 2: 1 Month Post-msRDN (30 ± 14 days) * Visit 3: 3 Months Post-msRDN (90 ± 28 days) * Visit 4: 6 Months Post-msRDN (180 ± 28 days) * Visit 5: 12 Months Post-msRDN (360 ± 28 days) * Visit 6: 24 Months Post-msRDN (720 ± 28 days) * Visit 7: 36 Months Post-msRDN (1080 ± 28 days) Final Follow-Up The midpoints of two adjacent follow-ups are used as the reference to determine which follow-up point the data belong to: if data are collected before the midpoint and accounted in the early follow-up;if data are collected after the midpoint and accounted in the later follow-up.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
