StudyFinder
A randomized placebo-procedure controlled trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary artery denervation Safety and Efficacy in patients with combined pre- and post-capillary pulmonary hypertension associated with Left Heart Disease
Status: Recruiting
A research study providing new treatment for pulmonary hypertension (high blood pressure in the arteries in the lungs) caused by left -sided heart disease. This study will evaluate the safety and effectiveness of investigational device called the Multi-Pole Pulmonary Artery Frequency Ablation Enhancor System ("Enhancor System").
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• Subject is diagnosed with left sided heart failure for at least 6 months prior to being evaluated for the study and remains symptomatic despite an optimal medication regimen as prescribed by their treating physician(s).
• Patient's vital signs and internal heart pressures completed at screening and day of investigational procedure, prior to investigational implant, meet the study's inclusion requirements.
• . Subject is willing to follow all aspects of the research study, including medication compliance, follow--up visits, and testing.
Exclusion Criteria:
• Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.
• Subject has any severe heart valve disease.
• Subject has had a stroke or mini-stroke within 30 days prior to study enrollment.
• Subject refuses blood products.
• Subject has severe chronic kidney disease or on dialysis
• Subject has severe liver disease
Interventions:
Drug/Device: Enhancor System
Conditions:
Pulmonary hypertension
Keywords:
Enhancor System, heart failure, pulmonary ablation, Pulmonary Hypertension
Contact(s): Danielle Holmes - dholmes7@hfhs.org
Principal Investigator: Waleed Al-Darzi
Principal Investigator ID: waldarz1@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov