Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady) (IMPROVE Brady)

September 16, 2021 updated by: Medtronic Cardiac Rhythm and Heart Failure
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is expected to provide evidence to support claim(s) that:

  • Education and process improvement initiatives can improve the diagnosis of and appropriate therapy application for sinus node dysfunction (SND)
  • The quality improvement methods studied have general applicability and can be used by all centers
  • Appropriate treatment minimizes caregiver burden
  • Appropriate treatment improves quality of life (QOL) and functional status compared to pre-implant

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Hospital General de Agudos
  • Bangladesh
      • Dhaka, Bangladesh
        • National Heart Foundation Hospital and Research Institute
      • Dhaka, Bangladesh
        • United Hospital Limited
  • India
      • Delhi, India
        • Max Devki Devi Heart and Vascular Institute
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Care Hospitals
    • DL
      • New Delhi, DL, India
        • MAX Balaji Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Care Insitute of Medical Sciences
    • Karnataka
      • Bangalore, Karnataka, India
        • RajaRajeswari Medical College & Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Madras Medical Mission Institute of Cardiovascular Diseases
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • King George's Medical University
    • West Bengal
      • Durgapur, West Bengal, India
        • The Mission Hospital
  • Mexico
      • Mexico City, Mexico
        • Hospital Central Militar
      • Mexico City, Mexico
        • Centro Médico Nacional de Occidente IMSS
      • Mexico City, Mexico
        • UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS
  • Peru
      • Arequipa, Peru
        • Hospital Nacional Carlos Alberto Seguin Escobedo
      • Lima, Peru
        • Instituto Nacional Cardiovascular
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454003
        • Chelyabinsk Federal Center of Cardiovascular Surgery
      • Krasnoyarsk, Russian Federation, 660020
        • Federal Center of Cardio-Vascular Surgery
      • Krasnoyarsk, Russian Federation, 660093
        • Center of Modern Cardiology
    • Amur Oblast
      • Amur, Amur Oblast, Russian Federation, 675006
        • Amur State Medical Academy
  • Uruguay
      • Montevideo, Uruguay
        • Casa de Galicia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with possible sinus node dysfunction

Description

Inclusion Criteria:

  • Patient is at least 18 years of age

  • Patient's heart rate meets at least one of the following:

    • Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50
    • Patient has a history of exercise intolerance
  • Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia).
  • Patient (or patient's legally authorized representative) is willing and able to sign and date written Patient Consent Form/Patient Data Release Consent

Exclusion Criteria:

  • Patient has type II 2nd degree AV block, High degree AV block (2:1, 3:1, 4:1 etc.) or 3rd degree AV block
  • Patient has recent history of blood loss
  • Patient has a medical history leading to suspicion of neurological disorder
  • Patient has a history of Chronic Atrial Fibrillation
  • Patient is enrolled or planning to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from the Medtronic study manager
  • Patient is not expected to survive for 12 months
  • Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Phase I
Control
Phase II
Treatment
Behavioral: Evidence based guidelines and tools
Education, guidelines, tools

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
Time Frame: Up to 1 year post enrollment
The absolute change in the proportion of subjects diagnosed with SND before and after intervention
Up to 1 year post enrollment
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
Time Frame: Up to 6 months post diagnosis
Outcome measure applies to subjects that receive a SND diagnosis
Up to 6 months post diagnosis

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
Time Frame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy.
SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
Change in Time to Diagnosis of SND Before and After Intervention
Time Frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months
Time to diagnosis days (date of diagnosis - date of enrollment)
From date of enrollment until date of SND diagnosis, assessed up to 60 months
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
Time Frame: From date of SND diagnosis until date of therapy, assessed up to 6 months
Time to implant in days (date of implant - date of diagnosis)
From date of SND diagnosis until date of therapy, assessed up to 6 months
Difference in QoL Between Implant Visit and 6 Months Post-implant
Time Frame: between implant visit and 6 months post-implant
The difference in quality of life was assessed using the SF-12 survey, with higher numbers indicating a better quality of life for the patient. The possible physical score ranges are between 24.0 and 56.6. The possible mental score ranges are between 19.1 and 60.8. Only the difference over time was reported.
between implant visit and 6 months post-implant
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
Time Frame: between implant visit and 6 months post-implant
The difference in caregiver burden was assessed using a Zarit survey, with lower numbers indicating a decreased burden or a better outcome for the caregiver. The possible range of scores was between 0 and 88. Only the difference in scores over time were reported.
between implant visit and 6 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMPROVE Brady

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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