N/A
N=1,342
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Sinus Node Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01643707 ↗Enrolled (actual)
1,342
Serious AEs
—
Results posted
Sep 2021
Primary outcome: Primary: The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention — 368; 409 Participants — p=<0.00001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Evidence based guidelines and tools (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention |
368; 409 | <0.00001 sig |
| PRIMARY The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention |
63; 130 | <0.0001 sig |
| SECONDARY The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy |
368; 409; 63; 130 | <0.0001 sig |
| SECONDARY Change in Time to Diagnosis of SND Before and After Intervention |
126; 232; 168; 156; 10; 7 | — |
| SECONDARY Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention |
22; 52; 37; 74; 1; 0 | — |
| SECONDARY Difference in QoL Between Implant Visit and 6 Months Post-implant |
11.7; 10.2 | — |
| SECONDARY Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant |
-14.7 | — |
Summary
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
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
Data sourced from ClinicalTrials.gov (NCT01643707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.