BridgeMD
New treatment option for Pulmonary Hypertension
Official title 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
ClinicalTrials.gov ID: NCT07662655
What this study is testing
What is Control group (receiving standard medical therapy alone)?
Control group (receiving standard medical therapy alone) is an investigational medicine, being studied as a potential treatment for pulmonary hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- No contraindications for PADN (e.g., anatomical abnormalities of the main pulmonary artery precluding catheter placement, known pulmonary artery...
- 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
You likely can't join if
- Cardiac index (CI) \< 1.5 L/min/m²;
- Severe renal insufficiency (creatinine clearance rate (CrCL) \< 30 mL/min);
- Left ventricular ejection fraction (EF) \<30% on echocardiography;
- Severe hematological disease or severe bleeding tendency (platelet count \<10×10⁹/L; severe and extensive bleeding; suspected or confirmed...
- Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or...
- Acute systemic infectious disease;
See the full eligibility criteria
- 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...
- 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
- Cardiac index (CI) \< 1.5 L/min/m²;
- Severe renal insufficiency (creatinine clearance rate (CrCL) \< 30 mL/min);
- Left ventricular ejection fraction (EF) \<30% on echocardiography;
- Severe hematological disease or severe bleeding tendency (platelet count \<10×10⁹/L; severe and extensive bleeding; suspected or confirmed intracranial hemorrhage);
- Systemic inflammatory disease, malignancy, tricuspid valve stenosis, pulmonary artery stenosis, and other cardiac diseases requiring surgical or treatment treatment;
- Acute systemic infectious disease;
- Poor general condition due to various systemic diseases;
- Pulmonary veno-occlusive disease;
- Cachexia;
- Diagnosed with WHO Group 1, 3, 4, or 5 pulmonary hypertension;
- Anticipated to undergo other surgical or treatment procedures within 6 months;
- Life expectancy \<12 months;
- Allergy to the drugs or metal materials used in the study;
- Women who are breastfeeding, pregnant, or planning to become pregnant within one year;
- Participation in another drug or medical device clinical trial within 3 months prior to screening;
- Any condition deemed unsuitable for participation in this clinical trial by the investigator. \|
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.