Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)
- Sponsor
- LivaNova
- Locations
- 3
- Primary Endpoint
- 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).
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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).
Time Frame: 6 months
Secondary Outcomes
- 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)