Clinical trial NCT01643707: Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Official title: Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Node Dysfunction
Keywords: Sick Sinus Syndrome
Bradycardia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 1342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with possible sinus node dysfunction

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

Eligibility 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

Primary outcomes:
measure: The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
timeFrame: Up to 1 year post enrollment
measure: The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
timeFrame: Up to 6 months post diagnosis
Secondary outcomes:
measure: The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
timeFrame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy
measure: Change in Time to Diagnosis of SND Before and After Intervention
timeFrame: From date of enrollment until date of SND diagnosis, assessed up to 60 months
measure: Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
timeFrame: From date of SND diagnosis until date of therapy, assessed up to 6 months
measure: Difference in QoL Between Implant Visit and 6 Months Post-implant
timeFrame: between implant visit and 6 months post-implant
measure: Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
timeFrame: between implant visit and 6 months post-implant
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos
city: Dhaka
country: Bangladesh
facility: National Heart Foundation Hospital and Research Institute
city: Dhaka
country: Bangladesh
facility: United Hospital Limited
city: Hyderabad
country: India
facility: CARE Hospitals
state: Andhra Pradesh
city: New Delhi
country: India
facility: Max Balaji Hospital
state: DL
city: Ahmedabad
country: India
facility: Care Insitute of Medical Sciences
state: Gujarat
city: Bangalore
country: India
facility: RajaRajeswari Medical College & Hospital
state: Karnataka
city: Chennai
country: India
facility: Madras Medical Mission Institute of Cardiovascular Diseases
state: Tamil Nadu
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Durgapur
country: India
facility: The Mission Hospital
state: West Bengal
city: Delhi
country: India
facility: Max Devki Devi Heart and Vascular Institute
city: Mexico City
country: Mexico
facility: Centro Medico Nacional de Occidente IMSS
city: Mexico City
country: Mexico
facility: Hospital Central Militar
city: Mexico City
country: Mexico
facility: UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguín Escobedo
city: Lima
country: Peru
facility: Instituto Nacional Cardiovascular
city: Amur
country: Russian Federation
facility: Amur State Medical Academy
state: Amur Oblast
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Federal Center of Cardiovascular Surgery
city: Krasnoyarsk
country: Russian Federation
facility: Federal Center of Cardio-Vascular Surgery
city: Krasnoyarsk
country: Russian Federation
facility: Center of Modern Cardiology
city: Montevideo
country: Uruguay
facility: Casa de Galicia
Study officials:
References: