NCT04306978

Brief Summary

The study results will be used to check the hypothesis that CareLink Express remote monitoring system increases the detection rate of asymptomatic AF and allows to change timely the treatment strategy in patients at high risk of thromboembolic events, e.g. anticoagulation therapy onset, electrical cardioversion or/and PVI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 21, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2018

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2023

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

5 years

First QC Date

December 23, 2018

Last Update Submit

March 8, 2021

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationtromboembolismremote monitoring

Outcome Measures

Primary Outcomes (1)

  • time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM

    the episode should be evaluated by the follow-up clinic physician(s) and meet the appropriate criteria (irregular RR intervals and distinct P waves, ≥30s episode duration)

    24 months

Secondary Outcomes (7)

  • thromboembolic events

    24 months

  • hospitalization for cardiovascular events

    24 months

  • the number of non-planned induced visits in the follow-up center

    24 months

  • correction in the medical therapy

    24 months

  • cardioversion

    24 months

  • +2 more secondary outcomes

Study Arms (2)

CareLink Express RM system

ACTIVE COMPARATOR

Patients in the remote monitoring (RM) group will undergo the implantation of Ensura DR MRI SureScan pacing system. Patients in the RM group should visit the main follow-up clinic 12 weeks after discharge, and then the device data will be remotely transmitted to the CareLink Express Network at least once in 3 months. Research personnel will contact patients by telephone once in 6 months. If participants indicate they have experienced a study outcome event (corresponding to the study endpoints), the event will be recorded. If remote transmission or telephone call data require to make clinical decision an in-hospital visit will be induced.

Other: CareLink Express RM system

Standard follow-up

ACTIVE COMPARATOR

Patients in the control group will receive Adapta DR pacing system without remote monitoring using. All patients from the control group should have the first in-hospital visit 12 weeks after pacemaker implantation. Then, the follow-up will be provided according to the standard guidelines

Other: Standard follow-up

Interventions

CareLink Express RM systemOTHER

CareLink Express remote monitoring system consists of implantable pacemaker CareLink Express station for implanted Medtronic cardiac devices and provides remote data transmissions

CareLink Express RM system
Standard follow-upOTHER

Follow-up will be provided according to the standard guidelines (HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations; 2008)

Standard follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with indications for implantation of dual chamber cardiac pacemaker
  • patients with no AF history;
  • written informed consent.

You may not qualify if:

  • patients with contraindications for CIED implantation;
  • patients with previously implanted CIEDs;
  • infection;
  • patients with previously diagnosed AF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute for Complex Problems of Cardiovascular Diseases

Kemerovo, 650061, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Sergey E Mamchur, M.D., Ph.D.

CONTACT

+79132985516sergei_mamchur@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Diagnosis of Cardiovascular Diseases

Study Record Dates

First Submitted

December 23, 2018

First Posted

March 13, 2020

Study Start

September 21, 2017

Primary Completion

September 21, 2022

Study Completion

January 21, 2023

Last Updated

March 10, 2021

Record last verified: 2021-03

Locations

RU(1)