Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients (SYNCHRO)

LivaNova

Status and phase

Withdrawn

Phase 4

Conditions

Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

Treatments

Other: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire

Study type

Interventional

Funder types

Industry

Identifiers

NCT02870647

ICSY03

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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