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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Medtronic Cardiac Rhythm Disease Management
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01643707
First received: June 28, 2012
Last updated: March 6, 2014
Last verified: March 2014

June 28, 2012
March 6, 2014
July 2012
November 2020   (final data collection date for primary outcome measure)
  • The absolute change in the proportion of subjects diagnosed with SND before and after intervention [ Time Frame: Assessed at 6 and 12 months of follow-up from enrollment ] [ Designated as safety issue: No ]
  • The absolute change in the proportion of subjects receiving indicated therapy before and after intervention [ Time Frame: Assessed at 3 and 6 months of follow-up from SND diagnosis ] [ Designated as safety issue: No ]
    Outcome measure applies to subjects that receive a SND diagnosis
Same as current
Complete list of historical versions of study NCT01643707 on ClinicalTrials.gov Archive Site
  • The proportion of Phase I subjects diagnosed with SND and the number of diagnoses that result in indicated therapy [ Time Frame: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment and receipt of therapy assessed at 3 and 6 months of follow-up from SND diagnosis ] [ Designated as safety issue: No ]
  • Change in time to diagnosis of SND before and after intervention [ Time Frame: From date of enrollment until date of SND diagnosis, assessed up to 60 months ] [ Designated as safety issue: No ]
    Time to diagnosis days (date of diagnosis - date of enrollment)
  • Change in time to receiving an indicated IPG device for subjects diagnosed with SND before and after intervention [ Time Frame: From date of SND diagnosis until date of therapy, assessed up to 60 months ] [ Designated as safety issue: No ]
    Time to diagnosis in days (date of implant - date of diagnosis)
  • Difference in caregiver burden between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ] [ Designated as safety issue: No ]
  • Change in Quality of Life (QOL) between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)

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

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
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with possible sinus node dysfunction

Sinus Node Dysfunction
Behavioral: Evidence based guidelines and tools
Education, guidelines, tools
  • Phase I
    Control
  • Phase II
    Treatment
    Intervention: Behavioral: Evidence based guidelines and tools
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14850
November 2020
November 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: IMPROVE Brady Study Team medtroniccrmtrials@medtronic.com
Argentina,   Bangladesh,   India,   Mexico,   Peru,   Russian Federation,   Uruguay
 
NCT01643707
IMPROVE Brady
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Not Provided
Medtronic Cardiac Rhythm Disease Management
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP