Chronic Evaluation of Respicardia Therapy

NCT ID: NCT01124370

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

remedē (TM) system

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Respicardia Therapy; Cardiac Concepts Therapy; (note: Respicardia was formerly Cardiac Concepts)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Respicardia, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Ponikowski, MD

Role: PRINCIPAL_INVESTIGATOR

4th Military Clinical Hospital with Polyclinic, Poland

William T Abraham, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

BryanLGH Heart Institute

Lincoln, Nebraska, United States

The Ohio State University

Columbus, Ohio, United States

Lancaster Heart and Stroke Foundation

Lancaster, Pennsylvania, United States

St. Thomas Heart

Nashville, Tennessee, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Heart and Diabetes Center

Bad Oeynhausen, , Germany

Köln University

Cologne, , Germany

University of Kiel

Kiel, , Germany

St. Adolf-Stift Hospital

Reinbek, , Germany

Policlinico di Monza-IRCCS

Monza, , Italy

Jagiellonian University

Krakow, , Poland

Medical Military Institute

Warsaw, , Poland

4th Military Hospital

Wroclaw, , Poland

Countries

United States; Germany; Italy; Poland

References

Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195.

Reference Type: DERIVED

PMID: 30325462 (View on PubMed)

Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11.

Reference Type: DERIVED

PMID: 25770408 (View on PubMed)

Other Identifiers

Respicardia - Chronic Study I

Identifier Type: -

Identifier Source: org_study_id