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Global SYMPLICITY Registry (GSR) Denervation Findings in Real World (DEFINE)- US Cohort is referred to as the GSR DEFINE- US Cohort study
A PROSPECTIVE, OBSERVATIONAL STUDY THAT WILL DOCUMENT THE LONG-TERM SAFETY, EFFECTIVENESS, AND DURABILITY OF RENAL DENERVATION IN A REAL-WORLD POPULATION, AGED 65 YEARS OR GREATER WITH HYPERTENSION IN THE UNITED STATES.
Contact(s):
Sarah Ackroyd - sackroy1@hfhs.org
Principal Investigator: Herbert Aronow
Principal Investigator ID: haronow1@hfhs.org
Sex: Male or Female
Age: 18 years and over
Phase: N/A
Healthy Volunteers:
Inclusion Criteria:
STUDY PARTICIPANTS ARE >65 YEARS, WITH DIAGNOSED HYPERTENSION AS SEEN AND EVALUATED BY CARDIOVASCULAR INTERVENTIONALIST.
Exclusion Criteria:
THERE IS NO EXCLUSION CRITERIA IN THIS OBSERVATIONAL STUDY.Interventions: Drug/Device: SYMPLICITY SPYRAL CATHETER
Conditions: HYPERTENSION, ISOLATED SYSTOLIC HYPERTENSION, COMBINED HYPERTENSION
Keywords: COMBINED HYPERTENSION, HYPERTENSION, ISOLATED SYSTOLIC HYPERTENSION
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
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").
Contact(s):
Danielle Holmes - dholmes7@hfhs.org
Principal Investigator: Waleed Al-Darzi
Principal Investigator ID: waldarz1@hfhs.org
Sex: Male or Female
Age: 18 years and over
Phase: N/A
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