Chronic Evaluation of Respicardia Therapy
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2010 |
| End Date: | August 2014 |
Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
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.
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.
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
We found this trial at
6
sites
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Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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