Cardiomyopathies, Congestive Heart Failure
Conditions
Brief summary
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.
Detailed description
During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be performed and compared. The results of the TFA analysis will not be used to select pacing lead location in this study. The patient will then receive the left ventricular pacing lead in the standard manner.
Interventions
DEVICEBiotronik Vision Guidewire
The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Nonrandomized survey of different pacing sites in the coronary veins.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Standard implantation for cardiac resynchronization ICD or PM implantation * Cardiomyopathy with LVEF \<35% * QRS duration greater than 120 msec
Exclusion criteria
\- Age less than 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRS Frequency at Each Paced Location | Baseline | Time frequency analysis performed at each location |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Unable to obtain study related data | 14 |
Baseline characteristics
| Characteristic | Coronary Sinus Branch Pacing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Need for implantation of a left ventricular pacing lead via the coronary sinus branch beins | 14 Participants |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized White | 13 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
QRS Frequency at Each Paced Location
Time frequency analysis performed at each location
Time frame: Baseline
Population: Unable to collect or analyze the data. Study was not feasible.