Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

Heart Failure Clinical Trial

Official title: Evaluation of Baroreflex Activation Therapy in Patients With Advanced Heart Failure

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT03230643
• Study type: Observational
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Status: Completed
• Start date: August 1, 2017
• Completion date: May 31, 2020