Chronic Evaluation of Respicardia Therapy

Respicardia

Status and phase: Completed; Phase 2

Conditions: Periodic Breathing; Sleep Disordered Breathing; Central Sleep Apnea; Sleep Apnea; Cheyne Stokes Respiration

Treatments: Device: remedē (TM) system

Study type: Interventional

Funder types: Industry

Identifiers

NCT01124370

Respicardia - Chronic Study I

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Candidate is at least 18 years old

• Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:

  • Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
  • Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
  • Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)

Exclusion criteria

• Candidates who are pregnant
• Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
• Candidates with severe COPD
• Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
• Candidates with unstable angina
• Candidates with history of primary pulmonary hypertension

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

Treatment

Experimental group

Description:

All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.

Treatment:

Device: remedē (TM) system