The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy

NCT02903940 | Completed FDA Device

• 1 other identifier: CRD_855
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ambulatory changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

  1 day

Study Arms (1)

CRT+NAVH

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

Device: CRT+NAVH

Interventions

CRT+NAVH DEVICE

Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis

CRT+NAVH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients already implanted with SJM Quadripolar CRT Pacing Systems will be enrolled in the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: December 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)