NCT03230643

Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Heart and Diabetes Center North-Rhine Westfalia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this single center prospective clinical trial is to evaluate the safety and efficacy of carotid Baroreflex Activation Therapy (BAT) in advanced heart failure (HFrEF). Beyond that, the primary aim of this study is to identify patients of the whole HFrEF population that are most likely to benefit from this new promising therapy.

Detailed description

Baroreflex activation therapy (BAT) is a new treatment option for patients (pts) suffering from heart failure with reduced left ventricular ejection fraction (HFrEF) to improve functional status and quality of life. Yet it is unknown which pts of the whole HFrEF population are most likely to benefit from this new promising therapy. As this invasive technique should definitely not be proposed for all HFrEF pts with left ventricular ejection fraction of 35 % or less the aim of this single center prospective clinical trial is to evaluate to which extent possible factors (e.g. cardiac resynchronization therapy (CRT), atrial fibrillation) may influence the response to BAT. To analyze any possible differences concerning the modulation of the autonomic nervous system caused by BAT in the presence of atrial fibrillation or cardiac resynchronization therapy, heart rate variability (HRV) analyses will be performed additionally. As autonomic nervous activity plays a pivotal role in the genesis and termination of atrial fibrillation any possible impact of baroreflex activation therapy on atrial fibrillation will be examined.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Barostim neo implantation	The Barostim neo Implantation is a new promising treatment option for patients with advanced heart failure (HEFrEF) as it might improve cardiac and vascular function by restoring sympathovagal-balance through its effects on the autonomic nervous system. In this observational study, data from patients who have received the Barostim neo System as part of clinical routine will be collected and analyzed. The implantation of this new device is not part of the study.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-10-15
• Completion: 2020-05-31
• First posted: 2017-07-26
• Last updated: 2020-08-07

Locations

1 site across 1 country: Germany