Brief Summary
The objective of the RELIEVE-HF study is to provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with New York Heart Association (NYHA) functional Class II, Class III, or ambulatory Class IV heart failure (HF), irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.
Brief Title
Reducing Lung CongestIon Symptoms in Advanced Heart Failure
Detailed Description
This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 500 patients will be randomized. Patients and all research staff managing the patients after randomization will be blinded during follow-up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt after 24 months once unblinding occurs, if they provide consent, and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of 5 years from the time of the study device implantation.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Heart Failure
Eligibility Criteria
Main Inclusion Criteria:
* Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
* NYHA Class II, Class III, or ambulatory Class IV HF
* Receiving guideline directed medical and device therapy (GDMT) for heart failure
* For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
* For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
Main Exclusion Criteria:
* Systolic blood pressure \<90 or \>160 mmHg
* Presence of Intracardiac thrombus
* Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR \> 4 WU
* Significant RV dysfunction - TAPSE \<12mm or RVFAC ≤25%
* Left Ventricular End-Diastolic Diameter (LVEDD) \>8cm
* Moderate to severe aortic or mitral stenosis
* Stroke or TIA or DVT within the last 6 months
* eGFR \<25 ml/min/1.73 m\^2
* Anatomical anomaly on TEE or ICE 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
* Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
* NYHA Class II, Class III, or ambulatory Class IV HF
* Receiving guideline directed medical and device therapy (GDMT) for heart failure
* For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
* For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
Main Exclusion Criteria:
* Systolic blood pressure \<90 or \>160 mmHg
* Presence of Intracardiac thrombus
* Pulmonary hypertension with PASP of ≥70 mm/Hg or PVR \> 4 WU
* Significant RV dysfunction - TAPSE \<12mm or RVFAC ≤25%
* Left Ventricular End-Diastolic Diameter (LVEDD) \>8cm
* Moderate to severe aortic or mitral stenosis
* Stroke or TIA or DVT within the last 6 months
* eGFR \<25 ml/min/1.73 m\^2
* Anatomical anomaly on TEE or ICE 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
Inclusion Criteria
Inclusion Criteria:
* Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
* NYHA Class II, Class III, or ambulatory Class IV HF
* Receiving guideline directed medical and device therapy (GDMT) for heart failure
* For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
* For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
* Both heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) patients
* NYHA Class II, Class III, or ambulatory Class IV HF
* Receiving guideline directed medical and device therapy (GDMT) for heart failure
* For NYHA Class III and ambulatory Class IV, at least one prior hospitalization for heart failure within the last year or elevated BNP level of at least 300 pg/ml or NT-proBNP level of at least 1,500 pg/ml. BNP/NT-ProBNP levels corrected for BMI
* For NYHA Class II, must have both hospitalization and elevated BNP levels as above specifications
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT03499236
Org Class
Industry
Org Full Name
V-Wave Ltd
Org Study Id
CL7018
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
RELIEVE-HF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure
Primary Outcomes
Outcome Description
Percentage of Treatment group patients experiencing any device-related Major Adverse Cardiovascular or Neurological Events (MACNE) during the first 30-days after randomization, compared to a pre-specified Performance Goal
Outcome Measure
Safety-Percentage of Treatment patients experiencing major device-related adverse events
Outcome Time Frame
30-days after randomization
Outcome Description
Treatment and Control groups will be compared using the Finkelstein-Schoenfeld method
Outcome Measure
Effectiveness-Hierarchical composite of death, heart transplant or left ventricular assist device (LVAD) implantation, HF hospitalizations, worsening HF events treated as an outpatient, and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Outcome Time Frame
Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
Secondary Outcomes
Outcome Description
6MWT changes
Outcome Time Frame
Baseline to 12 months
Outcome Measure
6MWT changes
Outcome Description
KCCQ changes
Outcome Time Frame
Baseline to 12 months
Outcome Measure
KCCQ changes
Outcome Description
KCCQ changes
Outcome Time Frame
Baseline through study completion, maximum of five years
Outcome Measure
KCCQ changes
Outcome Description
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Outcome Time Frame
Baseline through study completion, maximum of five years
Outcome Measure
Time to all-cause death, LVAD/Transplant, or heart failure hospitalization
Outcome Description
Time to all-cause death or first heart failure hospitalization
Outcome Time Frame
Baseline through study completion, maximum of five years
Outcome Measure
Time to all-cause death or first heart failure hospitalization
Outcome Description
Cumulative heart failure hospitalizations
Outcome Time Frame
Baseline through study completion, maximum of five years
Outcome Measure
Cumulative heart failure hospitalizations
Outcome Description
Time to first heart failure hospitalization
Outcome Time Frame
Baseline through study completion, maximum of five years
Outcome Measure
Time to first heart failure hospitalization
Outcome Description
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Outcome Time Frame
Baseline through study completion, maximum of five years
Outcome Measure
Modified Primary Effectiveness Endpoint including all-cause death, LVAD/Transplant, HF Hospitalizations, and worsening HF events treated as outpatient but without KCCQ
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Giora Weisz
Investigator Email
gweisz@montefiore.org
Investigator Phone