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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Sinus Node Dysfunction	Behavioral: Evidence based guidelines and tools

Study Design

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Study Type :	Observational
Estimated Enrollment :	14850 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Actual Study Start Date :	July 2012
Estimated Primary Completion Date :	November 2020
Estimated Study Completion Date :	November 2020

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 ]
2. 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 ]
   Outcome measure applies to subjects that receive a SND diagnosis

Secondary Outcome Measures :

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 and receipt of therapy assessed at 3 and 6 months of follow-up from SND diagnosis ]
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 60 months ]
   Time to diagnosis in days (date of implant - date of diagnosis)
4. Difference in caregiver burden between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ]
5. Change in Quality of Life (QOL) between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS	Recruiting
Mexico City, Mexico
Contact: Moises Calderon
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	Completed
Blagoveschensk, Russian Federation, 675006
Chelyabinsk Federal Center of Cardiovascular Surgery	Completed
Chelyabinsk, Russian Federation, 454003
Federal Center of Cardio-Vascular Surgery	Completed
Krasnoyarsk, Russian Federation, 660020
Center of Modern Cardiology	Completed
Krasnoyarsk, Russian Federation, 660093
Uruguay
Casa de Galicia	Recruiting
Montevideo, Uruguay
Contact: Walter Reyes Caorsi

Sponsors and Collaborators

Medtronic Cardiac Rhythm and Heart Failure

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:	NCT01643707 History of Changes
Other Study ID Numbers:	IMPROVE Brady
First Posted:	July 18, 2012
Last Update Posted:	April 4, 2018
Last Verified:	April 2018

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:

Sick Sinus Syndrome; Bradycardia

Additional relevant MeSH terms:

Sick Sinus Syndrome; Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases	Cardiovascular Diseases; Heart Block; Pathologic Processes