Device-based QRS Evaluation

Completed

• Conditions: Heart Failure

• 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

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

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

Primary Outcome Measures

Name	Time	Method
Characterize CRT IEGM-based estimations of QRS duration	Acute (1 day)

Trial Locations

Locations (1)

I.R.C.C.S. Policlinico San Donato; 🇮🇹 San Donato Milanese, MI, Italy