The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

NCT ID: NCT02903940

Last Updated: 2024-01-10

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to evaluate the application of Negative Atrioventricular Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT) patients.

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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CRT+NAVH

Surface ECG recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings.

CRT+NAVH

Intervention Type DEVICE

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Interventions

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CRT+NAVH

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Implanted with a functioning SJM Quadripolar CRT Pacing System
* QRS duration \> 140 ms
* Left bundle branch block documented
* Ability to provide informed consent for study participation
* Willing to comply with the study evaluation requirements
* At least 18 years of age

Exclusion Criteria

* CRT Pacing System implanted less than 1 week at time of enrollment
* CRT Pacing System implanted more than 24 months at time of enrollment
* CRT Pacing System implanted more than 90 days at time of enrollment AND intrinsic QRS duration is shorter than pre-implant intrinsic QRS duration by more than 10 ms
* Resting ventricular rate \>100 bpm
* Intrinsic PR interval \> 300 ms
* Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
* A recent myocardial infarction, ablation, drug intoxication, electrolyte imbalance, or any condition within the last 90 days that would be contraindicated for CRT programming changes in the opinion of the investigator
* Women who are pregnant or who plan 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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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CRD_855

Identifier Type: -

Identifier Source: org_study_id

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