- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838445
Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH) (RELIEVE-PAH)
August 27, 2023 updated by: V-Wave Ltd
RELIEVE-PAH TRIAL: REducing Right ventricuLar faIlure With thE V-waVe Shunt in Pulmonary Arterial Hypertension
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 up to 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.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William T. Abraham, M.D.
- Phone Number: (818)629-2164
- Email: bill@vwavemedical.com
Study Contact Backup
- Name: Beverly Walker, MSN, NP
- Phone Number: (818)629-2164
- Email: beverly@vwavemedical.com
Study Locations
-
-
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Québec, Canada
- Withdrawn
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
-
-
-
-
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Mexico City, Mexico
- Active, not recruiting
- Instituto Nacional de Cardiologia
-
-
-
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California
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Los Angeles, California, United States, 90033
- Recruiting
- Keck Medical Center of USC
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Contact:
- Sivagini Ganesh, MD
-
Principal Investigator:
- Sivagini Ganesh, MD
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Contact:
- Marc Simon, MD
-
Principal Investigator:
- Marc Simon, MD
-
-
Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
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Contact:
- Veronica Franco, MD
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Principal Investigator:
- Veronica Franco, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Main 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.
Main 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Time Frame: 3 months
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Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
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3 months
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Safety-Percentage of Treatment patients experiencing any major adverse event
Time Frame: 3 months
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Percentage of Treatment group patients experiencing any Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 90-days after implantation
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3 months
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Procedure Success-Percentage of patients successfully implanted with study device
Time Frame: 3 months
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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
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3 months
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Device Success-Percentage of patients implanted with right to left interatrial flow
Time Frame: 3 months
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Percentage of patients successfully implanted with the study device with right to left interatrial flow on echocardiography at 3 months
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from device related MACNE at 1 and 12 months after implantation
Time Frame: 1 and 12 months
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Freedom from device related Major Adverse Cardiac and Neurologic Events at 1 and 12 months after implantation.
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1 and 12 months
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Improvement in Exercise Capacity between baseline and 12 months
Time Frame: 12 months
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Improvement in Exercise Capacity measured by the six minute hall walk test from baseline to 12 months
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12 months
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Improvement in WHO Functional Class between baseline and 12 months
Time Frame: 12 months
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Improvement in World Health Organization Functional Class between baseline and 12 months.
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12 months
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Improvement in Quality of Life between baseline and 12 months
Time Frame: 12 months
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Improvement in Quality of Life as measured by the SF-36 questionnaire
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12 months
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Improvement in Quality of Life between baseline and 12 months
Time Frame: 12 months
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Improvement in Quality of Life as measured by the CAMPHOR questionnaire
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Victor Tapson, M.D., Cedars-Sinai Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2020
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
February 8, 2019
First Posted (Actual)
February 12, 2019
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 27, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL7012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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