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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01643707
Other study ID # IMPROVE Brady
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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