Trial Outcomes & Findings for Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization (NCT NCT03253809)
NCT ID: NCT03253809
Last Updated: 2022-03-09
Results Overview
Time frequency analysis performed at each location
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Baseline
Results posted on
2022-03-09
Participant Flow
Participant milestones
| Measure |
Coronary Sinus Branch Pacing
After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.
ECG signals will be saved digitally for analysis
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Coronary Sinus Branch Pacing
After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.
ECG signals will be saved digitally for analysis
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
|
|---|---|
|
Overall Study
Unable to obtain study related data
|
14
|
Baseline Characteristics
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization
Baseline characteristics by cohort
| Measure |
Coronary Sinus Branch Pacing
n=14 Participants
After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle.
ECG signals will be saved digitally for analysis
Biotronik Vision Guidewire: The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
|
Need for implantation of a left ventricular pacing lead via the coronary sinus branch beins
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Unable to collect or analyze the data. Study was not feasible.
Time frequency analysis performed at each location
Outcome measures
Outcome data not reported
Adverse Events
Coronary Sinus Branch Pacing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place