BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction (HFpEF)

CVRx

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: BAROSTIM NEO™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT02876042

360047-001

Details and patient eligibility

About

The purpose of this registry (NCT02876042) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO system in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension that also have evidence of heart failure with preserved ejection fraction (HFpEF).

Full description

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility Criteria:

The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include:

• Indications

  • Systolic blood pressure greater than or equal to 140 mmHg, and
  • Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications

• Contraindications

  • Bilateral carotid bifurcations located above the level of the mandible
  • Baroreflex failure or autonomic neuropathy
  • Uncontrolled, symptomatic cardiac bradyarrhythmias
  • Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
  • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign an Ethics Committee (EC) approved informed consent form for the registry.

• Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment.

• BAROSTIM THERAPY not yet chronically activated.

• Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant.

• On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment.

• Objective evidence of heart failure according to the following criteria:

  • Hospitalization for heart failure within 12 months prior to enrollment OR
  • Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 30 days prior to enrollment OR
  • NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600 pg/mL or BNP > 200 pg/mL) within 30 days prior to enrollment

Exclusion criteria

• Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
• Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.