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Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady) | Clinical Trials | Clareo Health

COMPLETED

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

NCT01643707•Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

Summary

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (21)

Hospital General de Agudos

Buenos Aires, Argentina

National Heart Foundation Hospital and Research Institute

Dhaka, Bangladesh

United Hospital Limited

Dhaka, Bangladesh

CARE Hospitals

Hyderabad, Andhra Pradesh, India

Care Insitute of Medical Sciences

Ahmedabad, Gujarat, India

RajaRajeswari Medical College & Hospital

Bangalore, Karnataka, India

Max Balaji Hospital

New Delhi, National Capital Territory of Delhi, India

Madras Medical Mission Institute of Cardiovascular Diseases

Chennai, Tamil Nadu, India

King George's Medical University

Lucknow, Uttar Pradesh, India

The Mission Hospital

Durgapur, West Bengal, India

Key Dates

Start Date

July 1, 2012

Primary Completion Date

January 30, 2019

Completion Date

January 31, 2019

Last Updated

September 17, 2021

Enrollment

1,342

ACTUAL participants

Conditions

Sinus Node Dysfunction

Interventions

Evidence based guidelines and tools

BEHAVIORAL

The Fluoroless-CSP Trial Using Electroanatomic Mapping

NCT03903107

Sinus Node DysfunctionHeart Block AV+2 more

View study

COMPLETED

Allometric-Pace Study

NCT05766462

Sinus Node Dysfunction

View study

COMPLETEDNA

ImageReady(TM) MR Conditional Pacing System Clinical Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 17, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Fluoroless-CSP Trial Using Electroanatomic Mapping

Allometric-Pace Study

ImageReady(TM) MR Conditional Pacing System Clinical Study

Effectiveness of Closed Loop Stimulation (CLS) With His Bundle Lead Placement

Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease