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

Medtronic

Status: Completed

Conditions: Sinus Node Dysfunction

Treatments: Behavioral: Evidence based guidelines and tools

Study type: Observational

Funder types: Industry

Identifiers

NCT01643707

IMPROVE Brady

Details and patient eligibility

About

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

Full 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

Enrollment: 1,342 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,342 participants in 2 patient groups

Phase I

Description:

Control

Phase II

Description:

Treatment

Treatment:

Behavioral: Evidence based guidelines and tools