TReatment of Pulmonary Hypertension Group II Study

NCT03611270 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLNS02-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR\>3 wood units.

Conditions

Pulmonary Hypertension (PH) Due to Left Heart Disease

Outcome Measures

Primary Outcomes (1)

• Procedural related Adverse Events (complications) at up to 30 days post procedure

  Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.

  30 days

Secondary Outcomes (13)

• Changes in cardiopulmonary exercise test

  4 month

• Change in resting mean right atrial pressure

  4 month

• Changes in 6MWD from baseline

  4 month

• Changes in Echocardiography parameters

  4 month

• Change in NT-BNP levels

  4 month

Interventions

Pulmonary Denervation DEVICE

Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
• Male or female, ≥ 18 years of age at the time of screening
• Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
• Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
• Patient with a current diagnosis of NYHA functional class II/III
• Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l

You may not qualify if:

• Pregnant women or women planning a pregnancy within 12 months of study enrolment
• Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
• Patient with life expectancy of less than a year
• Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
• Patient with pulmonary artery anatomy that precludes treatment
• Patient with moderate to severe pulmonary artery stenosis
• Patient with any pulmonary artery aneurysm
• Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
• Patient experiencing a current episode of acute decompensated heart failure
• Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.

Sponsors & Collaborators

• SoniVie Inc.: lead

Study Sites (3)

UC San Diego Medical Center

San Diego, California, 92037, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94158, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114-2696, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 2, 2018
• Study Start: November 30, 2018
• Primary Completion: December 1, 2023
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (3)