SMART Study in Real World

Launched by SYMAP MEDICAL (SUZHOU), LTD. · Jan 13, 2025

Keywords

ClinConnect Summary

The SMART Study in Real World is a clinical trial designed to explore a new treatment for people with uncontrolled high blood pressure, also known as hypertension. Specifically, the study is looking at a procedure called renal denervation, which aims to help reduce the number of blood pressure medications patients need to take. Researchers will recruit around 1,000 participants from over 30 hospitals in China. These participants will be followed for at least three years after the procedure to see how safe and effective it is in managing their blood pressure.

To be eligible for the study, participants must be at least 18 years old and have hypertension that is difficult to control with medications, or they must not tolerate these medications well. They will need to agree to receive the renal denervation treatment and attend follow-up appointments as required. It’s important to note that the study is not currently recruiting participants, but it aims to help those who struggle with high blood pressure by potentially reducing their need for multiple medications.

Gender

ALL

Eligibility criteria

• • 1. \*\*Inclusion Criteria (for A. Prospective Cohort)\*\*
• • Patients are ≥18 years old;
• • Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications;
• • Patients consent to receive msRDN treatment using the commercially available msRDN system by SyMap Medical (Suzhou), Ltd and to fulfill follow-up requirements.
• • 2. \*\*Exclusion Criteria (for A. Prospective Cohort)\*\*
• • Subjects are withdrawn from the study due to various reasons;
• • Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.
• • 3. \*\*Inclusion Criteria (for B. Retrospective Cohort)\*\*
• • Patients are ≥18 years old;
• • Patients with drug-resistant hypertension patients who are intolerant to drug therapy and, in either case, need to reduce medications;
• • Patients who have been received msRDN procedure using commercially available msRDN system by SyMap Medical (Suzhou), Ltd;
• • 4. \*\*Exclusion Criteria (for B. Retrospective Cohort) \*\*
• • Subjects are withdrawn from the study due to various reasons;
• • Investigators, ethics committees or regulatory agencies may halt or terminate the study due to medical perspectives or ethical considerations.