NCT01124370

Chronic Evaluation of Respicardia Therapy

Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Respicardia, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias. The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study. It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.

Conditions

• Sleep Disordered Breathing
• Cheyne Stokes Respiration
• Periodic Breathing
• Sleep Apnea
• Central Sleep Apnea

Interventions

Type	Name	Description
DEVICE	remedē (TM) system	Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods.

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-05-17
• Last updated: 2016-05-16
• Results posted: 2015-08-31

Locations

13 sites across 4 countries: United States, Germany, Italy, Poland