Trial record 3 of 13 for:
Open Studies | adoption
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
This study is currently recruiting participants.
Verified April 2013 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Medtronic Cardiac Rhythm Disease Management
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01643707
First received: June 28, 2012
Last updated: April 16, 2013
Last verified: April 2013
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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 2017 |
| Estimated Primary Completion Date: | November 2017 (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
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 | Not yet recruiting |
| Buenos Aires, Argentina | |
| Contact: Carlos Labadet | |
| Not yet recruiting | |
| La Boca, Argentina | |
| Bangladesh | |
| National Heart Foundation Hospital and Research Institute | Recruiting |
| Dhaka, Bangladesh | |
| Contact: Fazila Tun-Nesa Malik | |
| India | |
| CARE Hospitals | Recruiting |
| Hyderabad, Andhra Pra, India | |
| Contact: Calambur Narasimhan | |
| Max Balaji Hospital | Recruiting |
| New Delhi, DL, India | |
| Contact: Mohan Nair | |
| Care Insitute of Medical Sciences | Recruiting |
| Ahmedabad, Gujarat, India | |
| Contact: Ajay Naik | |
| The Mission Hospital | Recruiting |
| Bidhannagar Durgapur, West Bengal, India | |
| Contact: Ashok Parida | |
| Max Devki Devi Heart and Vascular Institute | Not yet 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 | |
| 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: | April 16, 2013 |
| 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 May 16, 2013