Clinical Assessment of Essential Remote Monitoring Functi... | NCT05165095

Status Module

Record Verification Date

May 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

Mar 25, 2022Actual

Primary Completion Date

Sep 5, 2023Actual

Completion Date

Jul 2027Estimated

First Submitted Date

Nov 23, 2021

First Submission Date that Met QC Criteria

Dec 6, 2021

First Posted Date

Dec 21, 2021Actual

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

May 30, 2024

Last Update Posted Date

May 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

Detailed Description

All patients will be included just after implantation and will then be followed during 48 months after inclusion.

At each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

206Estimated

Name	Type	Description	Arm Group Labels	Other Names
Pacemaker implantation	Device	De novo implantation, device upgrade to dual chamber or device replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits		1 to 3 months post-inclusion visit (M1-M3)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function at the inclusion and the M1-M3 visits		1 to 3 months post-inclusion visit (M1-M3)
Technical remote alerts documented at the M1-M3 visit		1 to 3 months post-inclusion visit (M1-M3)

Secondary Outcomes

Measure	Description	Time Frame
Right Atrial Autothreshold values up to the M48 visit		48 months post-inclusion visit (M48)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit		48 months post-inclusion visit (M48)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement)
Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated
Patient reviewed, signed and dated the ICF

Exclusion Criteria:

Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
Patient with permanent AF
Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
Minor age patient (i.e. under 18 years of age)
Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
Patient unavailable for the follow-up visits scheduled
Non-menopausal women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients indicated (class I or II) for a dual chamber pacemaker (de novo implantation, device upgrade to dual chamber or device replacement), according to the most recent guidelines from the ESC.

Sampling Method

Probability Sample

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms