Back to resultsRivet PVS Therapy in Group 2 PH-HFpEF Canada
Primary Purpose
Heart Failure, Pulmonary Hypertension
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Rivet Shunt
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Select Inclusion Criteria:
- Age ≥ 18 years
Prior diagnosis of Group 2 PH due to HFpEF, with at least one of the following resting hemodynamic criteria confirmed in the past year by right heart catheterization
- mPAP > 20 mmHg at rest
- mPAP/CO slope > 3 mmHg/L/min with exercise
- Confirmation of the following hemodynamic criteria during supine exercise: PCWP ≥ 25 mmHg, or PCWP/CO slope > 2 mmHg/L/min
Chronic symptomatic heart failure documented by the following:
- NYHA HF Class II with history > II, or Class III, or ambulatory Class IV
- ≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value > 400 pg/mL in normal sinus rhythm or > 750 pg/mL in atrial fibrillation in past 6 months
- Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating cardiologist according to current ACCF/AHA guidelines that is expected to be maintained without change for 1 month (excluding diuretic dosage changes for HF optimization within 30 days of the Index Procedure)
- 6MWD ≥ 100 m
Select Exclusion Criteria:
- Any therapeutic intracardiac intervention within the last 30 days
- PH Group 1, 3, 4 or 5
- Mean RAP >16 mmHg by RHC at rest on room air
Right ventricular dysfunction, defined as one or more of the following
- Greater than moderate RV dysfunction as assessed by TTE and/or MRI
- RV FAC < 35%
- TAPSE < 14 mm via TTE
- RV size severely enlarged compared to LV size as estimated by TTE and/or MRI
- Severe tricuspid valve regurgitation
- Peak systolic pulmonary arterial pressure > 80 mmHg by RHC at rest while awake
- Mean pulmonary arterial pressure > 50 mmHg by RHC at rest while awake
- PVR > 6 Wood units at rest while awake on room air
- Left ventricular ejection fraction < 50%
Severe heart failure, defined as one or more of the following:
- ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
- If BMI < 30, Cardiac Index < 2.0 L/min/m2
- If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2
- Requires continuous intravenous inotropic infusion
- Requires mechanical circulatory support
- Currently on the cardiac transplant waiting list
- Chronic renal dysfunction defined as: eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation
Chronic pulmonary disease defined as one or more of the following:
- Requires continuous home oxygen therapy
- Recent hospitalization for exacerbation within 12 months prior to screening
- FEV1 < 50% predicted
Sites / Locations
- University of Ottawa Heart Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rivet Shunt Therapy
Arm Description
Outcomes
Primary Outcome Measures
Rate of Major Adverse Events
Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at implantation procedure (Day 0) and up to 1-month post-procedure (Day 30)
Rate of Technical Success of the Rivet Shunt Implantation Procedure
Study device is implanted as intended and confirmation of a patent pulmonary-to-venous shunt between the RPA and SVC by qualitative assessment via angiography and/or echocardiography at implantation procedure.
Secondary Outcome Measures
Adverse Events through 12 months
Composite of MACCRE and re-intervention for study device related complications (as described above), progression of PH and/or HF disease, and all-cause mortality to 12 months post-procedure
Change in Hemodynamics at 12 months - PCWP
Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline
Change in Kansas City Cardiomyopathy Questionnaire
Change in KCCQ score between baseline and 12 months.
Change in RV Chamber Size at 12 months - Diameter
Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05332873
Brief Title
Rivet PVS Therapy in Group 2 PH-HFpEF Canada
Official Title
Safety and Efficacy of the Rivet Pulmonary-to-Venous Shunt (PVS) Therapy in Patients With Group 2 Pulmonary Hypertension (PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NXT Biomedical
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical investigation is a prospective, multicenter, non-randomized, open-label, Early Feasibility Study to evaluate the safety, performance, and initial clinical efficacy of the Rivet PVS therapy in patients with symptomatic pulmonary hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Pulmonary Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rivet Shunt Therapy
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Rivet Shunt
Intervention Description
The Rivet Shunt device will be implanted via a percutaneous, transcatheter approach
Primary Outcome Measure Information:
Title
Rate of Major Adverse Events
Description
Composite of major adverse cardiac, cerebrovascular, or renal events (MACCRE) and re-intervention for study device related complications at implantation procedure (Day 0) and up to 1-month post-procedure (Day 30)
Time Frame
1 month
Title
Rate of Technical Success of the Rivet Shunt Implantation Procedure
Description
Study device is implanted as intended and confirmation of a patent pulmonary-to-venous shunt between the RPA and SVC by qualitative assessment via angiography and/or echocardiography at implantation procedure.
Time Frame
At time of procedure
Secondary Outcome Measure Information:
Title
Adverse Events through 12 months
Description
Composite of MACCRE and re-intervention for study device related complications (as described above), progression of PH and/or HF disease, and all-cause mortality to 12 months post-procedure
Time Frame
12 months
Title
Change in Hemodynamics at 12 months - PCWP
Description
Change in exercise pulmonary capillary wedge pressure (PCWP) from baseline
Time Frame
12 Months
Title
Change in Kansas City Cardiomyopathy Questionnaire
Description
Change in KCCQ score between baseline and 12 months.
Time Frame
12 months
Title
Change in RV Chamber Size at 12 months - Diameter
Description
Change in RV Chamber Size (Diameter) assessed by a core lab between baseline and 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Select Inclusion Criteria:
Age ≥ 18 years
Prior diagnosis of Group 2 PH due to HFpEF, with at least one of the following resting hemodynamic criteria confirmed in the past year by right heart catheterization
mPAP > 20 mmHg at rest
mPAP/CO slope > 3 mmHg/L/min with exercise
Confirmation of the following hemodynamic criteria during supine exercise: PCWP ≥ 25 mmHg, or PCWP/CO slope > 2 mmHg/L/min
Chronic symptomatic heart failure documented by the following:
NYHA HF Class II with history > II, or Class III, or ambulatory Class IV
≥ 1 HF hospitalization, or healthcare facility with IV diuretics or intensification of oral diuresis for HF within 12 months, or NT-pro BNP value > 400 pg/mL in normal sinus rhythm or > 750 pg/mL in atrial fibrillation in past 6 months
Ongoing stable guideline directed medical therapy (GDMT) for HF and medically optimized per treating cardiologist according to current ACCF/AHA guidelines that is expected to be maintained without change for 1 month (excluding diuretic dosage changes for HF optimization within 30 days of the Index Procedure)
6MWD ≥ 100 m
Select Exclusion Criteria:
Any therapeutic intracardiac intervention within the last 30 days
PH Group 1, 3, 4 or 5
Mean RAP >16 mmHg by RHC at rest on room air
Right ventricular dysfunction, defined as one or more of the following
Greater than moderate RV dysfunction as assessed by TTE and/or MRI
RV FAC < 35%
TAPSE < 14 mm via TTE
RV size severely enlarged compared to LV size as estimated by TTE and/or MRI
Severe tricuspid valve regurgitation
Peak systolic pulmonary arterial pressure > 80 mmHg by RHC at rest while awake
Mean pulmonary arterial pressure > 50 mmHg by RHC at rest while awake
PVR > 6 Wood units at rest while awake on room air
Left ventricular ejection fraction < 50%
Severe heart failure, defined as one or more of the following:
ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF
If BMI < 30, Cardiac Index < 2.0 L/min/m2
If BMI ≥ 30, Cardiac Index < 1.8 L/min/m2
Requires continuous intravenous inotropic infusion
Requires mechanical circulatory support
Currently on the cardiac transplant waiting list
Chronic renal dysfunction defined as: eGFR < 35 mL/min/1.73 m2 by the CKD-Epi equation
Chronic pulmonary disease defined as one or more of the following:
Requires continuous home oxygen therapy
Recent hospitalization for exacerbation within 12 months prior to screening
FEV1 < 50% predicted
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krystal Santiago
Phone
949-385-3134
Email
ksantiago@nxtbiomedical.com
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Feagan
Phone
613-696-7000
Ext
12678
Email
hfeagan@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Benjamin Hibbert, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rivet PVS Therapy in Group 2 PH-HFpEF Canada
We'll reach out to this number within 24 hrs