Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady) (IMPROVE Brady)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01643707 |
Recruitment Status
:
Recruiting
First Posted
: July 18, 2012
Last Update Posted
: April 4, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

Group/Cohort | Intervention/treatment |
---|---|
Phase I
Control
|
|
Phase II
Treatment
|
Behavioral: Evidence based guidelines and tools
Education, guidelines, tools
|
- 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 ]
- 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
- 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 ]
- 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)
- 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)
- Difference in caregiver burden between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ]
- Change in Quality of Life (QOL) between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643707
Contact: IMPROVE Brady Study Team | medtroniccrmtrials@medtronic.com |
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 |
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 Key Record Dates |
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 |