Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
NCT06052072 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-05-19
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
Conditions
- Group 2 Pulmonary Hypertension
- Heart Failure
Interventions
- DEVICE
-
Gradient Denervation System
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Sponsors & Collaborators
-
Gradient Denervation Technologies
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-20
- Primary Completion
- 2026-12-31
- Completion
- 2028-07-01
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Mobile Health Intervention in Pulmonary Arterial Hypertension
NCT03069716 ·Status: COMPLETED ·Phase: NA
-
Non-invasive Pulmonary Artery Prediction
NCT05622695 ·Status: UNKNOWN
-
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
NCT07137260 ·Status: RECRUITING
-
Developing Enhanced Prediction Models
NCT02983812 ·Status: COMPLETED
-
Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity
NCT02650232 ·Status: COMPLETED ·Phase: NA
-
Determine Return on Investment in Heart Failure Remote Monitoring Program
NCT02475577 ·Status: UNKNOWN ·Phase: NA
-
Sensation of Dyspnea and Experience of Patients With Heart Failure
NCT05596292 ·Status: UNKNOWN ·Phase: NA
-
Cardiovascular Precision Medicine & Remote Intervention
NCT05814562 ·Status: COMPLETED ·Phase: NA
-
Wireless, Intermittent Monitoring of Right Heart Pressures in HF
NCT01162707 ·Status: COMPLETED ·Phase: NA
-
Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
NCT03126994 ·Status: COMPLETED ·Phase: NA
-
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System
NCT01275846 ·Status: COMPLETED ·Phase: NA
-
Testing the Effects of Telehealth Monitoring on Rehospitalization and Self Care for Heart Failure Patients in Home Care
NCT00300261 ·Status: COMPLETED ·Phase: PHASE3
-
Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals
NCT02337790 ·Status: COMPLETED
-
A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy
NCT06031142 ·Status: COMPLETED
-
Autoimmune Basis for Postural Tachycardia Syndrome
NCT02725060 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure
NCT04665011 ·Status: COMPLETED
-
Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure
NCT02368184 ·Status: WITHDRAWN
-
Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes
NCT04398654 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Repository of Phase Signals for Pulmonary Hypertension Algorithm Development
NCT04031989 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Thoracic Bio-reactance Measurement of Cardiac Output in Pulmonary Hypertension
NCT03890627 ·Status: COMPLETED
-
Early Detection of Health Deterioration in Elderly Patients After Hospitalization for Heart Failure Decompensation
NCT06126848 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Novel Wearable Device for Heart Failure Management
NCT05642650 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population
NCT01975402 ·Status: COMPLETED
-
Automated Hovering for Congestive Heart Failure Patients
NCT02708654 ·Status: COMPLETED ·Phase: NA
-
Better Effectiveness After Transition - Heart Failure
NCT01360203 ·Status: COMPLETED ·Phase: NA