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

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

Study Overview

• Status: Completed
• Conditions: Sinus Node Dysfunction
• Intervention / Treatment: Behavioral: Evidence based guidelines and tools

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: Observational
• Enrollment (Actual): 1342

Contacts and Locations

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 Medico 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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase I; Control
Phase II; Treatment	Behavioral: Evidence based guidelines and tools; Education, guidelines, tools

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention	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	Outcome measure applies to subjects that receive a SND diagnosis	Up to 6 months post diagnosis

Secondary Outcome Measures

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	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 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 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	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	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

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (Estimate): July 18, 2012

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Bradycardia; Sick Sinus Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Sick Sinus Syndrome
• Other Study ID Numbers: IMPROVE Brady