Health Condition 1: null- Sinus Node Dysfunction (SND)
Conditions
Interventions
Sponsors
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
| Measure | Time frame |
|---|---|
| Evaluate the impact of the intervention on the diagnosis of SNDTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the impact of the intervention on SND subjects receiving an indicated IPG device.Timepoint: 12 months | — |
Countries
Bangladesh, India
Contacts
India Medtronic Pvt Ltd