Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Heart Failure Clinical Trial

— PreVail-PH2  

Official title:

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06052072
• Other study ID #: CIP-002
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: November 2023
• Source: Gradient Denervation Technologies
• Contact: Julie Messer
• Phone: 763-657-7036
• Email: clinical[@]gradientdenervation.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Description:

Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

Inclusion Criteria:

• Heart Failure with EF = 40% (by TTE within last 3 months)

• Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest

• Pulmonary Vascular Resistance (PVR) = 3WU at rest

• Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise

• Cardiac index (CI) = 1.2 L/min/m2

• NYHA Class II or III

• Glomerular Filtration Rate (GFR) = 25 ml/min

• N-terminal pro-B-type natriuretic peptide (NT-proBNP) = 400pg/mL

• Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment

Exclusion Criteria:

• Life expectancy of < 2 years

• Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel

• Unable to tolerate right heart catheterization

• Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device

• Severe aortic, mitral or pulmonary valve regurgitation

• Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy

• Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Hypertension, Pulmonary

Intervention

Device:
• Gradient Denervation System
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Gradient Denervation Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device and procedure related serious adverse events	Number and frequency of serious adverse events deemed to be related to the investigational device and/or procedure.	Through 30 days post-procedure
Secondary	Change in PVR	Mean change from baseline in PVR	Measured at 1- and 6- months post-procedure