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

Sinus Node Dysfunction Clinical Trial

— IMPROVE Brady  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643707
• Other study ID #: IMPROVE Brady
• Status: Completed
• Start date: July 2012
• Est. completion date: January 31, 2019

Study information

• Verified date: September 2021
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1342
• Est. completion date: January 31, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Behavioral:
• Evidence based guidelines and tools
Education, guidelines, tools

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Argentina,  Bangladesh,  India,  Mexico,  Peru,  Russian Federation,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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