The purpose of this study is to evaluate the application of Negative Atrioventricular
Hysteresis (NAVH) to improve electrical synchrony in Cardiac Resynchronization Therapy (CRT)
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Full eligibility criteria for NCT02903940
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT02903940
United States (1)
Cleveland, Ohio, United States, 44195
View full eligibility
Tris trial is registered with FDA with number: NCT02903940. The sponsor of the trial is Abbott Medical Devices and it is looking for 40 volunteers for the current phase.
Official trial title: The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy
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