PreVail-PH: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension

• Sponsor: Gradient Denervation Technologies (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05951166
• Collaborator: (none)
• Enrollment: 15
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 10.9
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Patients With Pulmonary Hypertension	Device: Gradient Denervation System	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation SystemA prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension
• Actual Study Start Date: May 5, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PADN with Gradient Denervation System	Device: Gradient Denervation System; Pulmonary artery denervation (PADN) procedure

Outcome Measures

Primary Outcome Measures

1. Device and procedure related serious adverse events [30 days post-ablation]

Secondary Outcome Measures

1. Mean change from baseline in Pulmonary Vascular Resistance (woods units) [30 and 120 days post-ablation]

2. Mean change from baseline in 6MWT distance (m) [30 and 120 days post-ablation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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) ≥ 1.7 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:

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

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

• Systemic infection or localized infection/rash at planned access site at time of procedure

• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months

• CRT or other Interventional cardiac procedure (except RHC) within last 3 months

• Any planned cardiac procedure or inpatient procedure within the next 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Israeli-Georgian Medical Research Clinic Helsicore	Tbilisi		Georgia
2	Tbilisi Heart Clinic	Tbilisi		Georgia

Sponsors and Collaborators

• Gradient Denervation Technologies

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gradient Denervation Technologies
• ClinicalTrials.gov Identifier: NCT05951166
• Other Study ID Numbers: CIP-001
• First Posted: Jul 18, 2023
• Last Update Posted: Jul 18, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hypertension, Pulmonary; Hypertension; Heart Failure

Study Results

No Results Posted as of Jul 18, 2023