NCT05953558

Brief Summary

Transvenous cardiac pacemakers have pitfalls due to lead- and device pocket-related complications. Leadless pacemakers were developed and introduced into clinical practice to overcome the weaknesses of traditional transvenous pacemakers. The absence of atrial pacing has restricted their uses mainly for cases of paroxysmal atrioventricular block (AVB) or AVB with atrial fibrillation. The Micra AV contains an embedded accelerometer that senses the atrial contraction waveform, allowing the ventricle to be paced once the atrial contraction is complete. This atrioventricular synchronization is intended to extend the use of the device to cases of permanent complete AVB with normal sinus function. Two randomized clinicals trials have been proven it's efficacy. However, with AV-CESAR cohort, we aim to evaluate the real word effectiveness of Micra AV, in the first 1000 patients implanted by the device in France.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
May 2023Dec 2027

Study Start

First participant enrolled

May 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 21, 2023

Last Update Submit

July 17, 2023

Conditions

Atrioventricular Synchrony by the Micra AV

Keywords

Pacemaker syndromeDual chamber pacemaker upgradeQuality of lifeSF36 questionnaireEffectivenessComplications

Outcome Measures

Primary Outcomes (3)

  • Profile of patients implanted with Micra AV

    Description of the population of patients implanted by the device : age, sex, comorbidities (rate of hypertension, diabetes, ischemic heart disease, heart failure, severe pulmonary disease, severe chronic renal failure, cirrhosis, severe impairement of mobility, severe psychiatric disease or demencia and TAVR)

    Through study completion, an average of 3 years

  • Follow-up occurrence of upgrading to a dual-chamber pacemaker

    Rate of pacemaker syndrome and requirement of dual-chamber pacemaker upgrade

    Through study completion, an average of 3 years

  • Early and late device-related complications

    Rate of inhospital and late complications related to Micra AV

    Through study completion, an average of 3 years

Secondary Outcomes (2)

  • Assessment of the quality of life in permanent atrioventricular block and normal sinus function subgroup

    Through study completion, an average of 3 years

  • Risk factors of a compromised quality of life

    Through study completion, an average of 3 years

Interventions

Patients implanted with Micra AVDEVICE

The first 1000 patients implanted by the device in France

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The first 1000 patients implanted with Micra AV in France since May 29, 2020

You may qualify if:

  • All patients who underwent Micra AV implantation

You may not qualify if:

  • Refusal of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Cardiovascular Research Centre (AV-CESAR Investigators)

Paris, 75015, France

RECRUITING

Study Officials

  • Eloi Marijon, MD,PhD

    Paris Sudden Death Expertise Center

    PRINCIPAL INVESTIGATOR

  • Fawzi Kerkouri, MD

    University hospital of Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eloi Marijon, MD,PhD

CONTACT

+33662833848eloi.marijon@inserm.fr

Fawzi Kerkouri, MD

CONTACT

+33767149558eecmcfawzikerkouri@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 20, 2023

Study Start

May 1, 2023

Primary Completion

November 1, 2023

Study Completion (Estimated)

December 31, 2027

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

FR(1)