Heart Failure Clinical Trial
Official title:
The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
NCT number | NCT02903940 |
Other study ID # | CRD_855 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2016 |
Est. completion date | December 2022 |
Verified date | January 2024 |
Source | Abbott Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2022 |
Est. primary completion date | October 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Abbott Medical Devices |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis over a range of programmable values | 1 day | ||
Secondary | Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis | 1 day |
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