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Completed

NCT Number: NCT01643707

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Agudos, Buenos Aires, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evidence based guidelines and tools

Behavioral

Education, guidelines, tools

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: IMPROVE Brady

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jul 18, 2012
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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