Surgical Removal of Carotid Body in Patients With Systolic Heart Failure (FIM)

Noblewell

Status

Completed

Conditions

Systolic Heart Failure

Peripheral Chemoreceptor Hypersensitivity

Treatments

Procedure: Carotid body excision

Study type

Interventional

Funder types

Industry

Identifiers

NCT01653821

FIM-WROCPL-CORIDEA

Details and patient eligibility

About

The aim of the study is to determine safety, tolerability and feasibility of unilateral and bilateral carotid body excision in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
Stable clinical state within at least 4 weeks prior to inclusion
Subject >= 18 years old
Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method)
Carotid body present in computer cervical angiotomography
History of exacerbated peripheral chemoreceptor sensitivity determined as >0.6L/min/%SpO2
Able and willing to give written informed consent

Exclusion criteria

Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion
History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder
History of heart transplant
Pregnancy or anticipation of pregnancy
Hemodialysis or peritoneal dialysis patients
Obstructive carotid atherosclerotic disease with >50% stenosis
Severe sleep apnea syndrome diagnosed in PSG
COPD stage III and IV according to GOLD 2007
Unable to perform the spiroergometric assessment
Any significant anomaly in additional investigation which may increase the risk of study procedure