Post-market Surveillance of Micorport CRM Cardiac Implant... | NCT05694572

Studies
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices

NCT05694572

Sponsor

MicroPort CRM

Status

Recruiting

Last Update Posted

Jan 17, 2024Actual

Enrollment

2,500Estimated

Phase

Not provided

Conditions

Cardiac Rhythm Disorder
Heart Failure
Sudden Cardiac Death

Interventions

Implantation of a CIED

Countries

Portugal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2023Actual

Primary Completion Date

Jun 15, 2031Estimated

Completion Date

Jun 15, 2031Estimated

First Submitted Date

Dec 20, 2022

First Submission Date that Met QC Criteria

Jan 20, 2023

First Posted Date

Jan 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2024

Last Update Posted Date

Jan 17, 2024Actual

Description Module

Brief Summary

The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.

Detailed Description

PIANO Post Market Surveillance (PMS) investigation will cover MicroPort CRM systems CE- market and released since 2018.

Continuous monitoring of MicroPort CRM market-released systems will also enable to:

confirm the safety and performance of the device throughout the study duration
identify previously unknown side-effects and monitoring the identified side-effects and contraindications,
identify and analyse emergent risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio
identify possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,500Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Pacemaker system	Patients implanted with ENO or ALIZEA family pacing systems	Device: Implantation of a CIED
ICD system	Patients implanted with ULYS family ICD systems	Device: Implantation of a CIED
CRT-D system	Patients implanted with GALI family CRT-D systems	Device: Implantation of a CIED

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of a CIED	Device	Implantation of a CIED	CRT-D system ICD system Pacemaker system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chronic complication free rate of MicroPort CRM market-released system	Complications are defined as device-related reinterventions or deaths	Through study duration, an average of 5 years

Secondary Outcomes

Measure	Description	Time Frame
Acute complication free rate	Complications are defined as device-related reinterventions or deaths	Up to 3 months post-implant
Overall complication free rate	Complications are defined as device-related reinterventions or deaths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who meet all the following criteria at the time of the inclusion visit may be enrolled in the study:

Subject implanted with one of the following MicroPort CRM market-released system:
- ENO, TEO, OTO, ALIZEA, BOREA, or CELEA PM single chamber (SR) or dual chamber (DR) implanted after 01 January 2020 in combination with at least one XFINE or VEGA pacing lead
- ULYS, EDIS ICD single chamber (VR) or dual chamber (DR) system in combination with an INVICTA defibrillation lead. Additional XFINE or VEGA atrial pacing lead is optional.
- GALI CRT-D implanted in combination with an INVICTA defibrillation lead. Additional NAVIGO left ventricular pacing lead is optional.
- GALI SONR CRT-D in combination with an INVICTA defibrillation lead and with either a NAVIGO left ventricular or a SONRTIP atrial pacing lead.
- Future generation of market approved MicroPort CRM PM, ICD or CRT-D device associated with existing or future generation of MicroPort CRM lead
Subject equipped with Remote Monitoring System (RMS) (only for subject implanted with ICD or CRT-D system)
Subject followed yearly per standard practice by investigational site: in-clinic visit or remote visit through remote monitoring system
Subject reviewed, signed and dated the Informed Consent Form (ICF) if applicable per country regulation

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible to be enrolled in the study:

Age less than 18 years old or more than 90 years at time of inclusion, incapacitated or under guardianship or kept in detention
Life expectancy less than 1 year
Currently enrolled in an active study of MicroPort CRM

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects implanted with a pacemaker, an Implantable Cardioverter-Defibrillator (ICD) or a Cardiac Resynchronization Therapy (CRT-D) Class I or II indication according to the latest guidelines from the European Society of Cardiology (ESC)1 or from the American College of Cardiology (ACC)/ American Heart Association (AHA)/ Heart Rhythm society (HRS)2 as appropriate per geography.

Sampling Method

Non-Probability Sample

ID	Term
D001145	Arrhythmias, Cardiac
D006333	Heart Failure
D016757	Death, Sudden, Cardiac

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms