RecruitingNot Applicable

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

United States, Canada, Mexico20 participantsStarted 2020-02-14

Plain-language summary

The objectives of the RELIEVE-PAH study are to obtain first-in-human experience with the study device in patients with severe pulmonary arterial hypertension, including evidence of initial safety, device performance and possible signals of clinical effectiveness.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
✓. WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
✓. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

Exclusion criteria

✕. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
✕. Mean Right Atrial Pressure \>20 mmHg.
✕. Severe restrictive or obstructive lung disease.
✕. Evidence of organ dysfunction other than right heart failure.
✕. Left ventricular ejection fraction \<40 %.
✕. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
✕. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
✕. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.

What they're measuring

Safety-Percentage of Treatment patients experiencing major device-related adverse events

Timeframe: 3 months

Safety-Percentage of Treatment patients experiencing any major adverse event

Timeframe: 3 months

Procedure Success-Percentage of patients successfully implanted with study device

Timeframe: 3 months

Device Success-Percentage of patients implanted with right to left interatrial flow

Timeframe: 3 months

Trial details

NCT IDNCT03838445

SponsorV-Wave Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

William T. Abraham, M.D.

(818)629-2164 bill@vwavemedical.com

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
✓. WHO Functional Class III or IV symptoms. If WHO Class III, at least 1 High-Risk characteristic or 2 Intermediate-Risk characteristics from the 2015 ESC Guidelines.
✓. Receiving maximal available and tolerable pharmacological PAH therapy ≥3 months at a stable dose for ≥1 month.

Exclusion criteria

✕. Resting oxygen saturation \<90 % without supplemental oxygen corrected for altitude.
✕. Mean Right Atrial Pressure \>20 mmHg.
✕. Severe restrictive or obstructive lung disease.
✕. Evidence of organ dysfunction other than right heart failure.
✕. Left ventricular ejection fraction \<40 %.
✕. Anatomical anomaly on transesophageal echocardiography or intracardiac echocardiography that precludes implantation of Shunt across fossa ovalis (FO) of the interatrial septum.
✕. Inadequate vascular access for implantation of shunt, e.g. femoral venous access for transseptal catheterization and inferior vena cava (IVC) is not patent.
✕. Hemodynamic heart rhythm, or respiratory instability at time of Final Exclusion Criteria.

What they're measuring

Safety-Percentage of Treatment patients experiencing major device-related adverse events

Timeframe: 3 months

Safety-Percentage of Treatment patients experiencing any major adverse event

Timeframe: 3 months

Procedure Success-Percentage of patients successfully implanted with study device

Timeframe: 3 months

Device Success-Percentage of patients implanted with right to left interatrial flow

Timeframe: 3 months