The Application of Negative Atrioventricular Hysteresis in Cardiac Resynchronization Therapy With MultiPoint Pacing
1 other identifier
observational
17
1 country
1
Brief Summary
The purpose of this study is to evaluate the application of Negative AV Hysteresis (NAVH) to improve electrical synchrony in MultiPoint Pacing (MPP) Cardiac Resynchronization Therapy (CRT) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2016
CompletedFirst Posted
Study publicly available on registry
May 25, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJanuary 10, 2024
January 1, 2024
3.9 years
May 19, 2016
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute change in QRS duration due to CRT with NAVH, relative to intrinsic conduction
Acute changes in surface ECG QRS duration resulting from Cardiac Resynchronization Therapy (CRT) with Negative Atrioventricular Hysteresis (NAVH) over a range of programmable values
1 day
Secondary Outcomes (2)
Acute changes in LV pressure-volume hemodynamics due to CRT with NAVH, relative to intrinsic conduction
1 day
Change in QRS duration after one day of CRT with NAVH, relative to intrinsic conduction
1 day
Study Arms (1)
CRT+NAVH
Surface ECG and pressure-volume loop recordings will be taken during the adjustment of programmable Cardiac Resynchronization Therapy and Negative Atrioventricular Hysteresis settings at the device implant procedure
Interventions
Eligibility Criteria
Enrollment will include patients scheduled to be implanted with MultiPoint Pacing-enabled SJM Quadripolar Pacing Systems
You may qualify if:
- Scheduled for implantation of an MPP-enabled 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:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
I.R.C.C.S. Policlinico San Donato
San Donato Milanese, MI, 20097, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2016
First Posted
May 25, 2016
Study Start
June 1, 2016
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
January 10, 2024
Record last verified: 2024-01