Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

Bradycardia Clinical Trial

— DREAM  

Official title:

Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537718
• Other study ID #: IBSY04
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2012
• Last updated: July 16, 2013
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: July 2013
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

Description:

The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:

• Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines

• Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker

• Patients who provide signed and dated informed consent

Exclusion Criteria:

• Inability to understand the purpose of the study or refusal to co-operate

• Unavailability for scheduled follow-ups at the implanting centre

• Already included in another clinical study that could affect the results of this study

• Inability or refusal to provide informed consent

• Patient is minor (less than 18-years old)

• Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)

• Patient is forfeiture of freedom or under guardianship

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• REPLY 200
REPLY 200 pacemaker

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-based sensitivity of breathing troubles	Evaluation of this outcome requires measuring the number of ventilation pauses and ventilation reductions detected during the same night using SDB Monitoring function or the reference in-lab PSG (clinical assessment).	1 day	No
Primary	Event-based Positive Predictive Value of breathing troubles	The Event-based Positive Predictive Value (PPV)of breathing troubles is complementary to Sensitivity. It is the proportion of abnormal events appropriately detected by SDB Monitoring function compared to the total number of abnormal events detected by SDB Monitoring function.	1 day	No
Secondary	Apnea Index-based Positive Predictive Value	The objective is to assess the Positive Prédictive Value of the SDB Monitoring function based on RDI stored in the pacemaker and the AHI derived from in-lab Polysomnography during the same night.	1 day	No
Secondary	Apnea Index-based Negative Predictive Value	The objective is to assess the NPV of the SDB Monitoring function based on RDI stored in the pacemaker or the AHI derived from in-lab Polysomnography during the same night.	1 day	No
Secondary	Safety based on Adverse events	The objective will allow to assess the safety with the summarize all adverse events through 3-month follow-up related to the implant procedure and pacing system or related to any other cause.	3 months	Yes