Device-based QRS Evaluation

NCT ID: NCT02814214

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ECG+IEGM

Surface ECG and intracardiac electrogram recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy settings

ECG+IEGM

Intervention Type DEVICE

Cardiac Resynchronization Therapy programming adjustments

Interventions

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ECG+IEGM

Cardiac Resynchronization Therapy programming adjustments

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

San Donato Milanese, MI, Italy

Site Status

Countries

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Italy

Other Identifiers

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CRD_865

Identifier Type: -

Identifier Source: org_study_id

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