Device-based QRS Evaluation

The purpose of this study is to collect simultaneous surface electrocardiogram (ECG) recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM) recordings of variations in electrical synchrony.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Already implanted with SJM Quadripolar CRT Pacing System
Ability to provide informed consent for study participation
Willing to comply with the study evaluation requirements
At least 18 years of age

Exclusion criteria

Resting ventricular rate >100 bpm
Intrinsic PR interval > 300 ms
Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
Pregnant or plans to become pregnant during the study

Treatment and study plan

ECG+IEGM

Device

Cardiac Resynchronization Therapy programming adjustments

Primary outcomes

Characterize CRT IEGM-based estimations of QRS duration

Time frame: Acute (1 day)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jun 27, 2016
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed