Prospective, international, non-randomized, multicentre, clinical investigation (phase IV).
The aim of the study is to investigate the correlation between HF, severe SBD, and AF in
CRT-P patients at 6 months.
Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02870647
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patient successfully* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
Signed and dated informed consent
The subject will be available for postoperative follow-up beyond one year
Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
Already included in another clinical study that could confound the results of this study
Not available to attend routine follow-up visits
Not able to understand the aim of the study and its procedures
Minor age (according to local regulation)
Drug / alcohol addiction or abuse
All locations for NCT02870647
Ospedale Niguarda Ca Granda
Milano, Italy, 20162
Barcelona, Spain, 08036
CHU de Vigo
View full eligibility
Tris trial is registered with FDA with number: NCT02870647. The sponsor of the trial is LivaNova and it is looking for 0 volunteers for the current phase.
Official trial title: Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
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