NCT02876042

BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction

BAROSTIM THERAPY ™ in Heart Failure With Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 70 (estimated)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	BAROSTIM NEO™ System	Implantation of the BAROSTIM NEO™ System

Timeline

• Start date: 2017-03-23
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2016-08-23
• Last updated: 2023-04-20

Locations

13 sites across 1 country: Germany

Regulatory

• FDA-regulated device study