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

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ClinicalTrials.gov Identifier: NCT03838445
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
V-Wave Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Device: V-Wave Interatrial Shunt Not Applicable

Detailed Description:
This is a multi-national, multi-center, prospective, non-randomized, open label trial of patients implanted with the study device. A total of 20 patients will be implanted with the study device and followed at regular intervals for 1 year and then annually for a total of 5 years post implant.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Experimental: Therapy: V-Wave Shunt
Treatment arm patients will undergo a diagnostic right heart catheterization and invasive echocardiography to determine study eligibility followed by transseptal catheterization and V-Wave Shunt implantation.
Device: V-Wave Interatrial Shunt
The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovals and straddles the interatrial septum.




Primary Outcome Measures :
  1. Safety-Percentage of Treatment patients experiencing major device-related adverse events [ Time Frame: 3 months ]
    Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

  2. Safety-Percentage of Treatment patients experiencing any major adverse event [ Time Frame: 3 months ]
    Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation

  3. Procedure Success-Percentage of patients successfully implanted with study device [ Time Frame: 3 months ]
    Percentage of patients successfully implanted with the study device at the intended location across the interatrial septum during the index procedure compared to patients with attempted implantations

  4. Device Success-Percentage of patients implanted with right to left interatrial flow [ Time Frame: 3 months ]
    Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months


Secondary Outcome Measures :
  1. Freedom from device related MACNE at 1 and 12 months after implantation [ Time Frame: 1 and 12 months ]
    Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.

  2. Improvement in Exercise Capacity between baseline and 12 months [ Time Frame: 12 months ]
    Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months

  3. Improvement in WHO Functional Class between baseline and 12 months [ Time Frame: 12 months ]
    Improvement in World Health Organization Functional Class between baseline and 12 months.

  4. Improvement in Quality of Life between baseline and 12 months [ Time Frame: 12 months ]
    Improvement in Quality of Life as measured by the SF-36 questionnaire

  5. Improvement in Quality of Life between baseline and 12 months [ Time Frame: 12 months ]
    Improvement in Quality of Life as measured by the CAMPHOR questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Group 1 PAH (idiopathic, connective tissue disease, HIV, corrected congenital heart disease).
  2. World Health Organization Functional Class III or IV symptoms or history of syncope.
  3. Receiving maximal available and tolerable pharmacological PAH therapy at stable dose for ≥4 months.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838445


Contacts
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Contact: William T. Abraham, M.D. (818)629-2164 bill@vwavemedical.com
Contact: Beverly Walker, MSN, NP (818)629-2164 beverly@vwavemedical.com

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Joe Santiago, RRT, CCRP    614-366-4593    Joseph.santiago@osumc.edu   
Principal Investigator: Veronica Franco, M.D.         
Sponsors and Collaborators
V-Wave Ltd
Investigators
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Principal Investigator: Victor Tapson, M.D. Cedars-Sinai Medical Center

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Responsible Party: V-Wave Ltd
ClinicalTrials.gov Identifier: NCT03838445     History of Changes
Other Study ID Numbers: CL7012
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by V-Wave Ltd:
Pulmonary Arterial Hypertension
PAH
Interatrial Shunt
Interatrial Shunting
Atrial Septostomy
Additional relevant MeSH terms:
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Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases