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Percutaneous Pulmonary Artery Denervation (PADN) for the Treatment of Pulmonary Hypertension After Transcatheter Mitral Valve Edge-to-Edge Repair (M-TEER): A Prospective Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

this study aims to investigate the efficacy and safety of PADN therapy compared with standard medical therapy in patients diagnosed with pulmonary hypertension after M-TEER, thereby providing evidence for clinical treatment decision-making

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age ≥18 years and ≤80 years;

• Diagnosed with pulmonary hypertension (defined as mPAP \>20 mmHg measured by right heart catheterization) at least 3 months after successful M-TEER, having received guideline-directed medical therapy (GDMT) for at least 2 months;

• No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery stenosis, uncontrolled severe arrhythmias);

• Understands and is willing to sign the informed consent form and authorizes the use of health and study-related information;

• Willing to comply with the treatment and follow-up schedule required by the protocol

Locations
Other Locations
China
Structural Heart Disease Unit, Xiamen Cardiovacular Hospital
RECRUITING
Xiamen
Contact Information
Primary
Xiang CHEN, Dr
seanchenx@126.com
+8618033997788
Time Frame
Start Date: 2026-06-06
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 60
Treatments
Experimental: PADN group (receiving PADN plus standard medical therapy)
PADN group (receiving PADN plus standard medical therapy)
Placebo_comparator: Control group (receiving standard medical therapy alone)
Control group (receiving standard medical therapy alone)
Related Therapeutic Areas
Sponsors
Leads: Xiamen Cardiovascular Hospital, Xiamen University

This content was sourced from clinicaltrials.gov