Atrial FibrillationNCT04306978
Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation
A study testing CareLink Express RM system and Standard follow-up in people with Atrial Fibrillation, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CareLink Express RM system and Standard follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 21 Sep 2017to 21 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with indications for implantation of dual chamber cardiac pacemaker
- patients with no AF history;
- written informed consent.
Who cannot join
- patients with contraindications for CIED implantation;
- patients with previously implanted CIEDs;
- infection;
- patients with previously diagnosed AF
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Research Institute for Complex Problems of Cardiovascular Diseases
Kemerovo, 650061
Sergey E Mamchur, M.D., Ph.D., +79132985516, sergei_mamchur@mail.ru
About this study
Official title: Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation and Cardiovascular Risk Reduction in Patients With Implantable Cardiac Pacemakers
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.
Read the detailed description
It is expected to enroll 200 consecutive patients without previously diagnosed AF, who have indications for implantation of dual chamber cardiac pacemakers according to the current guidelines. All the patients will be randomly assigned into 2 groups. Patients in the RM group will undergo the implantation of Ensura DR MRI SureScan pacing system, whereas patients in the control group will receive ADAPTA DR pacing system without RM using. The impact of the Care Link Express service on prevention of thromboembolism will be evaluated. The rate of in-hospital visits for 1 patient per year and compliance with scheduled CareLink transmissions (ratio of the number of the performed transmissions to the planned ones) will be assessed in all patients in the remote monitoring group. Moreover, we are going to estimate the interaction between the follow-up center and other healthcare facilities equipped with the CareLink Express service, which will facilitate faster treatment decision.
- Conditions
- Atrial Fibrillation
- Being tested
- CareLink Express RM system, Standard follow-up
- Keywords
- atrial fibrillation, tromboembolism, remote monitoring
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Standard follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 months
Secondary outcomes (7)
thromboembolic events
Number of participants with ischaemic stroke, transient ischaemic attack and thromboembolism (including any arterial embolism and paradoxical embolism)
Measured: 24 months
hospitalization for cardiovascular events
Number of participants with arrhythmia, heart failure decompensation, thromboembolic events
Measured: 24 months
the number of non-planned induced visits in the follow-up center
Number of visits for 1 patient per year
Measured: 24 months
correction in the medical therapy
Number of participants with antiarrhythmic therapy or/and oral anticoagulation therapy initiated after the AF detection
Measured: 24 months
cardioversion
Number of patinents underwent electrical cardioversion
Measured: 24 months
catheter/surgical PVI
Number of patients underwent catheter or surgical atrial fibrillation ablation
Measured: 24 months
all-cause mortality
Number of patients dead because of all causes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start21 Sep 2017
- Primary completion21 Sep 2022 (estimated)
- Study completion21 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Mamchur, Research Institute for Complex Problems of Cardiovascular Diseases, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306978
- Sponsor's protocol ID
- 0546-2015-0017
- Status last verified
- Mar 2021
- First submitted
- 23 Dec 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the CareLink Express Remote Monitoring System on Early Detection of Atrial Fibrillation and Cardiovascular Risk Reduction in Patients With Implantable Cardiac Pacemakers
- ClinicalTrials.gov ID
- NCT04306978
- Acronym / sponsor ID
- 0546-2015-0017
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, tromboembolism, remote monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research Institute for Complex Problems of Cardiovascular Diseases, RussiaUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 21 Sep 2022 (estimated)
- Study completion
- 21 Jan 2023 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It is expected to enroll 200 consecutive patients without previously diagnosed AF, who have indications for implantation of dual chamber cardiac pacemakers according to the current guidelines. All the patients will be randomly assigned into 2 groups. Patients in the RM group will undergo the implantation of Ensura DR MRI SureScan pacing system, whereas patients in the control group will receive ADAPTA DR pacing system without RM using. The impact of the Care Link Express service on prevention of thromboembolism will be evaluated. The rate of in-hospital visits for 1 patient per year and compliance with scheduled CareLink transmissions (ratio of the number of the performed transmissions to the planned ones) will be assessed in all patients in the remote monitoring group. Moreover, we are going to estimate the interaction between the follow-up center and other healthcare facilities equipped with the CareLink Express service, which will facilitate faster treatment decision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CareLink Express RM system | Active comparator | Other: CareLink Express RM systemPatients 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. |
| Standard follow-up | Active comparator | Other: Standard follow-upPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with indications for implantation of dual chamber cardiac pacemaker
- patients with no AF history;
- written informed consent.
Key exclusion criteria (4 listed)
- patients with contraindications for CIED implantation;
- patients with previously implanted CIEDs;
- infection;
- patients with previously diagnosed AF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareLink Express RM systemCareLink Express remote monitoring system consists of implantable pacemaker CareLink Express station for implanted Medtronic cardiac devices and provides remote data transmissions | Other | CareLink Express RM system |
| Standard follow-upFollow-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) | Other | Standard follow-up |
Primary outcome
time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM
Time frame: 24 months
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)
7 secondary outcomes
thromboembolic events
Time frame: 24 months
hospitalization for cardiovascular events
Time frame: 24 months
the number of non-planned induced visits in the follow-up center
Time frame: 24 months
correction in the medical therapy
Time frame: 24 months
cardioversion
Time frame: 24 months
catheter/surgical PVI
Time frame: 24 months
all-cause mortality
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareLink Express RM system and Standard follow-up in people with Atrial Fibrillation, run by Research Institute for Complex Problems of Cardiovascular Diseases, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergey E Mamchur, M.D., Ph.D. (+79132985516, sergei_mamchur@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time (days) from the pacemaker system implantation to the first AF episode detected by ESG or EGM (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.