The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.
The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%. During long-term follow-up, all participants are required to have at least one annual visit. Parameters assessed during long-term follow-up visits: * Physical Assessment * Subject Medications * Serious adverse events
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System.
Time frame: For the duration of the study, up to 5 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Calgary
Calgary, Alberta, Canada
University of Alberta - Edmonton
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
CHRU de Lille
Lille, France
CHU de Rennes
Rennes, France
CHU de Toulouse
Toulouse, France
Vivantes Hospital Berlin
Berlin, Germany
Immanuel Hospital Bernau-Heart Center Brandenburg
Bernau, Germany
...and 20 more locations