Device-based QRS Evaluation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02814214

Enrollment

103

Registered

2016-06-27

Start date

2016-06-30

Completion date

2017-09-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Interventions

DEVICEECG+IEGM

Cardiac Resynchronization Therapy programming adjustments

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Characterize CRT IEGM-based estimations of QRS duration	Acute (1 day)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026