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

NCT01643707 | Completed Results

• 1 other identifier: IMPROVE Brady
• Study Type: observational
• Target: 1,342
• Locations: 7 countries
• Sites: 21

Brief Summary

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

Conditions

Sinus Node Dysfunction

Keywords

Sick Sinus Syndrome; Bradycardia

Outcome Measures

Primary Outcomes (2)

• The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention

  The absolute change in the proportion of subjects diagnosed with SND before and after intervention

  Up to 1 year post enrollment

• The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention

  Outcome measure applies to subjects that receive a SND diagnosis

  Up to 6 months post diagnosis

Secondary Outcomes (5)

• The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy

  SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapy

• Change in Time to Diagnosis of SND Before and After Intervention

  From date of enrollment until date of SND diagnosis, assessed up to 60 months

• Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention

  From date of SND diagnosis until date of therapy, assessed up to 6 months

• Difference in QoL Between Implant Visit and 6 Months Post-implant

  between implant visit and 6 months post-implant

• Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant

  between implant visit and 6 months post-implant

Study Arms (2)

Phase I

Control

Phase II

Treatment

Behavioral: Evidence based guidelines and tools

Interventions

Evidence based guidelines and tools BEHAVIORAL

Education, guidelines, tools

Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with possible sinus node dysfunction

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (21)

Hospital General de Agudos

Buenos Aires, Argentina

Location

National Heart Foundation Hospital and Research Institute

Dhaka, Bangladesh

Location

United Hospital Limited

Dhaka, Bangladesh

Location

CARE Hospitals

Hyderabad, Andhra Pradesh, India

Location

Care Insitute of Medical Sciences

Ahmedabad, Gujarat, India

Location

RajaRajeswari Medical College & Hospital

Bangalore, Karnataka, India

Location

Max Balaji Hospital

New Delhi, National Capital Territory of Delhi, India

Location

Madras Medical Mission Institute of Cardiovascular Diseases

Chennai, Tamil Nadu, India

Location

King George's Medical University

Lucknow, Uttar Pradesh, India

Location

The Mission Hospital

Durgapur, West Bengal, India

Location

Max Devki Devi Heart and Vascular Institute

Delhi, India

Location

Centro Medico Nacional de Occidente IMSS

Mexico City, Mexico

Location

Hospital Central Militar

Mexico City, Mexico

Location

UMAE Hospital de Cardiologia Centro Medico nacional Siglo XXI IMSS

Mexico City, Mexico

Location

Hospital Nacional Carlos Alberto Seguín Escobedo

Arequipa, Peru

Location

Instituto Nacional Cardiovascular

Lima, Peru

Location

Amur State Medical Academy

Amur, Amur Oblast, 675006, Russia

Location

Chelyabinsk Federal Center of Cardiovascular Surgery

Chelyabinsk, 454003, Russia

Location

Federal Center of Cardio-Vascular Surgery

Krasnoyarsk, 660020, Russia

Location

Center of Modern Cardiology

Krasnoyarsk, 660093, Russia

Location

Casa de Galicia

Montevideo, Uruguay

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Non-randomized observational study, data collected in a limited region with 10 specialized centers.Assumptions on the effect of pacemaker therapy affordability were limited.QoL increases were not compared to an age and gender-matched control group.

Results Point of Contact

• Title: Sr Clinical Research Program Manager
• Organization: Medtronic

jennifer.tinsley@medtronic.com

+1 (651) 308 3608

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 18, 2012
• Study Start: July 1, 2012
• Primary Completion: January 30, 2019
• Study Completion: January 31, 2019
• Last Updated: September 17, 2021
• Results First Posted: September 17, 2021

Record last verified: 2021-09

Locations

UR (1); IN (8); PE (2); RU (4); BA (2); AR (1); ME (3)