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Trial record 26 of 62 for:    "Sick Sinus Syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01643707
Recruitment Status : Active, not recruiting
First Posted : July 18, 2012
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:

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

Condition or disease Intervention/treatment
Sinus Node Dysfunction Behavioral: Evidence based guidelines and tools

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Study Type : Observational
Actual Enrollment : 1346 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Actual Study Start Date : July 2012
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adoption

Group/Cohort Intervention/treatment
Phase I
Control
Phase II
Treatment
Behavioral: Evidence based guidelines and tools
Education, guidelines, tools




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
    Outcome measure applies to subjects that receive a SND diagnosis


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
    Time to diagnosis days (date of diagnosis - date of enrollment)

  3. 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 ]
    Time to diagnosis in days (date of implant - date of diagnosis)

  4. Difference in caregiver burden between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ]
  5. Change in Quality of Life (QOL) between implant visit and 6 months post-implant [ Time Frame: between implant visit and 6 months post-implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with possible sinus node dysfunction
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01643707


Locations
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Argentina
Hospital General de Agudos
Buenos Aires, Argentina
Bangladesh
National Heart Foundation Hospital and Research Institute
Dhaka, Bangladesh
United Hospital Limited
Dhaka, Bangladesh
India
CARE Hospitals
Hyderabad, Andhra Pradesh, India
Max Balaji Hospital
New Delhi, DL, India
Care Insitute of Medical Sciences
Ahmedabad, Gujarat, India
RajaRajeswari Medical College & Hospital
Bangalore, Karnataka, India
Madras Medical Mission Institute of Cardiovascular Diseases
Chennai, Tamil Nadu, India
King George's Medical University
Lucknow, Uttar Pradesh, India
The Mission Hospital
Bidhannagar Durgapur, West Bengal, India
Max Devki Devi Heart and Vascular Institute
New Dehli, India
Mexico
Centro Medico Nacional de Occidente IMSS
Mexico City, Mexico
Hospital Central Militar
Mexico City, Mexico
UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS
Mexico City, Mexico
Peru
Hospital Nacional Carlos Alberto Seguín Escobedo
Arequipa, Peru
Instituto Nacional Cardiovascular
Lima, Peru
Russian Federation
Amur State Medical Academy
Blagoveschensk, Russian Federation, 675006
Chelyabinsk Federal Center of Cardiovascular Surgery
Chelyabinsk, Russian Federation, 454003
Federal Center of Cardio-Vascular Surgery
Krasnoyarsk, Russian Federation, 660020
Center of Modern Cardiology
Krasnoyarsk, Russian Federation, 660093
Uruguay
Casa de Galicia
Montevideo, Uruguay
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure

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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01643707     History of Changes
Other Study ID Numbers: IMPROVE Brady
First Posted: July 18, 2012    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Sick Sinus Syndrome
Bradycardia

Additional relevant MeSH terms:
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Sick Sinus Syndrome
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease
Pathologic Processes