Chronic Evaluation of Respicardia Therapy

NCT01124370 | Completed Phase 2 Results

• 1 other identifier: Respicardia - Chronic Study I
• Study Type: interventional
• Target: 57
• Locations: 4 countries
• Sites: 13

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• AHI Change From Baseline at 3 Months

  Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.

  Baseline and 3 months on therapy

Secondary Outcomes (6)

• Related Adverse Events

  Up to 2 years

• Epworth Sleepiness Scale Change From Baseline at 6 Months

  Baseline and 6 months on therapy

• Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months

  Baseline and 6 months on therapy

• Heart Failure Clinical Composite

  6 months on therapy

• Six-minute Hall Walk Test Change From Baseline at 6 Months

  Baseline and 6 months on therapy

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: remedē (TM) system

Interventions

remedē (TM) system 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.

Also known as: Respicardia Therapy, Cardiac Concepts Therapy, (note: Respicardia was formerly Cardiac Concepts)

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Respicardia, Inc.: lead

Study Sites (13)

BryanLGH Heart Institute

Lincoln, Nebraska, 68506, United States

Location

The Ohio State University

Columbus, Ohio, United States

Location

Lancaster Heart and Stroke Foundation

Lancaster, Pennsylvania, 17602, United States

Location

St. Thomas Heart

Nashville, Tennessee, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

Heart and Diabetes Center

Bad Oeynhausen, Germany

Location

Köln University

Cologne, Germany

Location

University of Kiel

Kiel, Germany

Location

St. Adolf-Stift Hospital

Reinbek, Germany

Location

Policlinico di Monza-IRCCS

Monza, Italy

Location

Jagiellonian University

Krakow, Poland

Location

Medical Military Institute

Warsaw, Poland

Location

4th Military Hospital

Wroclaw, Poland

Location

Related Publications (2)

• 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.

  PMID: 30325462 DERIVED

• 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.

  PMID: 25770408 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Cheyne-Stokes Respiration; Sleep Apnea, Central

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Linda Nelson, VP Clinical Affairs
• Organization: Respicardia

lnelson@respicardia.com

952-540-4479

Study Officials

• Piotr Ponikowski, MD

  4th Military Clinical Hospital with Polyclinic, Poland

  PRINCIPAL INVESTIGATOR

• William T Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 16, 2016
• Results First Posted: August 31, 2015

Record last verified: 2016-04

Locations

PL (3); US (5); IT (1); DE (4)