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Device-based QRS Evaluation

Completed
Conditions
Heart Failure
Interventions
Device: ECG+IEGM
Registration Number
NCT02814214
Lead Sponsor
Abbott Medical Devices
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
103
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
ECG+IEGMECG+IEGMSurface ECG and intracardiac electrogram recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy settings
Primary Outcome Measures
NameTimeMethod
Characterize CRT IEGM-based estimations of QRS durationAcute (1 day)
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

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

🇮🇹

San Donato Milanese, MI, Italy

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