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

Sponsor

Gradient Denervation Technologies (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06052072

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Group 2 Pulmonary Hypertension Heart Failure	Device: Gradient Denervation System	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, single arm, multi-center, early feasibility studyProspective, single arm, multi-center, early feasibility study

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 Group 2 (PreVail-PH2 Study)

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PADN with Gradient Denervation System Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.	Device: Gradient Denervation System Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Arm

Intervention/Treatment

Experimental: PADN with Gradient Denervation System

Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

Device: Gradient Denervation System

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

Outcome Measures

Primary Outcome Measures

Device and procedure related serious adverse events [Through 30 days post-procedure]
Number and frequency of serious adverse events deemed to be related to the investigational device and/or procedure.

Secondary Outcome Measures

Technical success of the device [Through 1 day post-procedure]
The ability to complete the denervation procedure with no device related adverse events
Change in PVR [Measured at 1- and 6- months post-procedure]
Mean change from baseline in PVR
Change in 6MWT [Measured at 1- and 6- months post-procedure]
Mean change from baseline in 6MWT

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

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:

NCT06052072

Other Study ID Numbers:

CIP-002

First Posted:

Sep 25, 2023

Last Update Posted:

Sep 25, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Hypertension, Pulmonary

Hypertension

Heart Failure

Study Results

No Results Posted as of Sep 25, 2023