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

Completed

Conditions: Sinus Node Dysfunction

Interventions: Behavioral: Evidence based guidelines and tools

Registration Number: NCT01643707

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1342

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

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase II	Evidence based guidelines and tools	Treatment

Primary Outcome Measures

Name	Time	Method
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention	Up to 1 year post enrollment	The absolute change in the proportion of subjects diagnosed with SND before and after intervention
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention	Up to 6 months post diagnosis	Outcome measure applies to subjects that receive a SND diagnosis

Secondary Outcome Measures

Name	Time	Method
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy	SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy	Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy.
Change in Time to Diagnosis of SND Before and After Intervention	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	From date of SND diagnosis until date of therapy, assessed up to 6 months	Time to implant in days (date of implant - date of diagnosis)
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant	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.
Difference in QoL Between Implant Visit and 6 Months Post-implant	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.

Trial Locations

Locations (21): United Hospital Limited
🇧🇩
Dhaka, Bangladesh
Max Balaji Hospital
🇮🇳
New Delhi, DL, India
RajaRajeswari Medical College & Hospital
🇮🇳
Bangalore, Karnataka, India
King George's Medical University
🇮🇳
Lucknow, Uttar Pradesh, India
Care Insitute of Medical Sciences
🇮🇳
Ahmedabad, Gujarat, India
The Mission Hospital
🇮🇳
Durgapur, West Bengal, India
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, Mexico
Hospital General de Agudos
🇦🇷
Buenos Aires, Argentina
National Heart Foundation Hospital and Research Institute
🇧🇩
Dhaka, Bangladesh
CARE Hospitals
🇮🇳
Hyderabad, Andhra Pradesh, India
Max Devki Devi Heart and Vascular Institute
🇮🇳
Delhi, India
Madras Medical Mission Institute of Cardiovascular Diseases
🇮🇳
Chennai, Tamil Nadu, India
Center of Modern Cardiology
🇷🇺
Krasnoyarsk, Russian Federation
Hospital Nacional Carlos Alberto Seguín Escobedo
🇵🇪
Arequipa, Peru
Instituto Nacional Cardiovascular
🇵🇪
Lima, Peru
Casa de Galicia
🇺🇾
Montevideo, Uruguay
Amur State Medical Academy
🇷🇺
Amur, Amur Oblast, Russian Federation
Chelyabinsk Federal Center of Cardiovascular Surgery
🇷🇺
Chelyabinsk, Russian Federation
Federal Center of Cardio-Vascular Surgery
🇷🇺
Krasnoyarsk, Russian Federation