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Global, prospective, multi-center, post-market study is to characterize the current management of patients presenting with possible sinus node dysfunction (SND) and to assess practice-specific process improvement intervention

IMPROVE Brady Clinical Investigational Plan, Version2.0, 16 February 2012

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003345
Enrollment
14850
Registered
2013-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Sinus Node Dysfunction (SND)

Interventions

Intervention1: Intervention is going to be in the form of educational workshop: The IMPROVE Brady process improvement intervention toolkit may include an education workshop, diagnostic algorithm(s), p

Sponsors

India Medtronic Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. sinus rate 2. history of exercise intolerance 3. 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).

Exclusion criteria

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 1.Patient has recent history of blood loss 2.Patient has a medical history leading to suspicion of neurological disorder 3.Patient has a history of Chronic Atrial Fibrillation 4. 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 5.Patient is not expected to survive for 12 months

Design outcomes

Primary

MeasureTime frame
Evaluate the impact of the intervention on the diagnosis of SNDTimepoint: 6 months

Secondary

MeasureTime frame
Evaluate the impact of the intervention on SND subjects receiving an indicated IPG device.Timepoint: 12 months

Countries

Bangladesh, India

Contacts

Public ContactRajesh Radhakrishnan

India Medtronic Pvt Ltd

rajesh.radhakrishnan@medtronic.com02233074700

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026