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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01643707
First received: June 28, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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

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

Condition Intervention
Sinus Node Dysfunction
Behavioral: Evidence based guidelines and tools

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • The absolute change in the proportion of subjects diagnosed with SND before and after intervention [ Time Frame: Assessed at 6 and 12 months of follow-up from enrollment ] [ Designated as safety issue: No ]
  • The absolute change in the proportion of subjects receiving indicated therapy before and after intervention [ Time Frame: Assessed at 3 and 6 months of follow-up from SND diagnosis ] [ Designated as safety issue: No ]
    Outcome measure applies to subjects that receive a SND diagnosis


Secondary Outcome Measures:
  • 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 and receipt of therapy assessed at 3 and 6 months of follow-up from SND diagnosis ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Time to diagnosis days (date of diagnosis - date of enrollment)

  • 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 60 months ] [ Designated as safety issue: No ]
    Time to diagnosis in days (date of implant - date of diagnosis)

  • Difference in caregiver burden between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ] [ Designated as safety issue: No ]
  • Change in Quality of Life (QOL) between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 14850
Study Start Date: July 2012
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Phase I
Control
Phase II
Treatment
Behavioral: Evidence based guidelines and tools
Education, guidelines, tools

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with possible sinus node dysfunction

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643707

Contacts
Contact: IMPROVE Brady Study Team medtroniccrmtrials@medtronic.com

Locations
Argentina
Hospital General de Agudos Recruiting
Buenos Aires, Argentina
Contact: Carlos Labadet         
Bangladesh
National Heart Foundation Hospital and Research Institute Recruiting
Dhaka, Bangladesh
Contact: Fazila-Tu- Nesa Malik         
United Hospital Limited Recruiting
Dhaka, Bangladesh
Contact: Kaisar Nasrullah Khan         
India
CARE Hospitals Recruiting
Hyderabad, Andhra Pradesh, India
Contact: Calambur Narasimhan         
Max Balaji Hospital Terminated
New Delhi, DL, India
Care Insitute of Medical Sciences Recruiting
Ahmedabad, Gujarat, India
Contact: Ajay Naik         
RajaRajeswari Medical College & Hospital Recruiting
Bangalore, Karnataka, India
Contact: Yogesh Kothari         
Madras Medical Mission Institute of Cardiovascular Diseases Recruiting
Chennai, Tamil Nadu, India
Contact: Ulhas Pandurangi         
King George's Medical University Recruiting
Lucknow, Uttar Pradesh, India
Contact: Rishi Sethi         
The Mission Hospital Recruiting
Bidhannagar Durgapur, West Bengal, India
Contact: Ashok Parida         
Max Devki Devi Heart and Vascular Institute Recruiting
New Dehli, India
Contact: Vanita Arora         
Mexico
UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS Recruiting
Mexico City, Mexico
Contact: Moises Calderon         
Centro Medico Nacional de Occidente IMSS Recruiting
Mexico City, Mexico
Contact: Juan Jose Garcia Pinto         
Hospital Central Militar Recruiting
Mexico City, Mexico
Contact: Alfredo Echegaray Trelles         
Peru
Hospital Nacional Carlos Alberto Seguín Escobedo Recruiting
Arequipa, Peru
Contact: Pedro Torres Equiluz         
Instituto Nacional Cardiovascular Recruiting
Lima, Peru
Contact: Jorge Salinas Arce         
Russian Federation
Amur State Medical Academy Recruiting
Blagoveschensk, Russian Federation, 675006
Contact: Artem Verevetinov         
Chelyabinsk Federal Center of Cardiovascular Surgery Recruiting
Chelyabinsk, Russian Federation, 454003
Contact: Pavel Leonidovich Shugaev         
Center of Modern Cardiology Recruiting
Krasnoyarsk, Russian Federation, 660093
Contact: Konstantin Valentinovich Zlodeev         
Federal Center of Cardio-Vascular Surgery Recruiting
Krasnoyarsk, Russian Federation, 660020
Contact: Eduard Aleekseevich Ivanitsky         
Uruguay
Casa de Galicia Recruiting
Montevideo, Uruguay
Contact: Walter Reyes Caorsi         
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT01643707     History of Changes
Other Study ID Numbers: IMPROVE Brady
Study First Received: June 28, 2012
Last Updated: March 6, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Hungary: Scientific and Medical Research Council Ethics Committee
Mexico: Ethics Committee
Peru: Ethics Committee
India: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Sick Sinus Syndrome
Bradycardia

Additional relevant MeSH terms:
Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014