Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
Conditions
Brief summary
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.
Detailed description
The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up. The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period. Predictors of the clinical outcomes will be investigated.
Interventions
OTHEREchocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire
each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months
Sponsors
LivaNova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Known pregnancy * Under guardianship
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade). | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period. | 12 months |
Countries
Italy, Spain
Outcome results
None listed