TROPHY PAH Pivotal Study - TReatment of Pulmonary HYpertension for PAH Pivotal Study

NCT04570228 | Unknown FDA Device

• 1 other identifier: CLNS03-001 - TROPHY 3 Protocol
• Study Type: interventional
• Target: 205
• Locations: 0 countries
• Sites: N/A

Brief Summary

Theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6M, to assess the safety and effectiveness of pulmonary artery denervation with the TIVUS™ System in subjects with PAH. The study will assess improved and/or maintained exercise tolerance in patients with PAH through the analysis of exercise tolerance, hemodynamic changes, clinical worsening and the quality of life who got treated by the TIVUS system.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (2)

• 6 minute walking distance (6MWD)

  Statistical difference in 6MWD between the treated group and the sham control group

  6 months

• The rate of procedure and treatment related SAEs reported

  12 months

Secondary Outcomes (11)

• Statistical difference between the treated group and the sham control group in exercise tolerance as measured using the change in activity parameters using the Actigraph Centrepoint watch

  6 months

• Difference between time to clinical worsening event between the treated group and the sham control group

  6 months

• Difference between the number of clinical worsening events between the treated group and the sham control group

  6 months

• Difference between the treated group and the sham control group in resting mean right atrial pressure (mRAP)

  6 months

• Difference between the treated group and the sham control group in resting mean pulmonary artery pressure (mPAP)

  6 months

Other Outcomes (18)

• Clinical change of pulmonary arterial hypertension condition defined by escalation of PAH specific drug therapy

  6, 12, 24, 36 month

• Clinical change of pulmonary arterial hypertension condition defined by escalation of PAH specific drug therapy

  6, 12, 24, 36 month

• Clinical change of pulmonary arterial hypertension condition defined by escalation of concomitant drug therapy

  6, 12, 24, 36 month

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization and pulmonary artery angiography.

Device: Pulmonary artery denervation

Sham control group

SHAM COMPARATOR

A sham treatment of pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization pulmonary artery angiography. The sham procedure will be identical to the denervation procedure, with the only exception that the procedure will use a sham setting on the control console.

Device: Sham procedure

Interventions

Pulmonary artery denervation DEVICE

The TIVUS system will be used for pulmonary artery denervation using non focused ultrasound

Treatment group

Sham procedure DEVICE

A sham procedure would be performed using the TIVUS system without delivering the non focused ultrasound

Sham control group

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 subject, according to local regulations, prior to initiation of any study mandated procedure.
• Male or female ≥ 18 years of age at the time of screening
• Subject with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced, familial PAH or corrected congenital heart defects more than 1 year prior to enrollment, confirmed by right heart catheterization performed prior to screening and showing all of the following:
• Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest
• Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg
• Pulmonary vascular resistance (PVR) at rest \>3 Wood units (240 dyne\*s/cm\^5)
• Subject is on maximally tolerated medical therapy for PAH, as determined by his PAH physician
• Subject is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
• Subject is able to tolerate IV contrast used for the angiograms during treatment
• Subject is WHO functional class II or III

You may not qualify if:

• Subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months
• Subjects with portal-pulmonary hypertension, Group 2, 3 and 4 PH
• Pregnant women or women planning a pregnancy within 12 months of study enrolment
• Subject with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry
• Subject 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)
• Subject with pulmonary artery anatomy that precludes treatment with the TIVUS System
• Subject who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
• Subject experiencing a current episode of acute decompensated heart failure
• Subject who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrollment.
• Subject who has implantable Cardiomems device, or other implanted device that might be contraindicated for therapeutic ultrasound energy.

Sponsors & Collaborators

• SoniVie Inc.: lead

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Dalit Shav, PhD

CONTACT

+19784600773; info@sonivie.com

Charles S Carignan, MD

CONTACT

+19784600773; info@sonivie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 2:1 with a sham controlled arm, with subjects and all follow up staff blinded to the subject treatment. Subjects will be unblinded at 6M, and sham control group will be offered treatment at this time if they meet the inclusion/ exclusion criteria. The primary effectiveness endpoint is measured at 6 months. The safety endpoint for blinded patients is at 6 months, and for treated patients again at 12 months.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 30, 2020
• Study Start: January 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: April 1, 2022

Record last verified: 2022-03