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LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Sinus Branch Pacing | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotronik Vision Guidewire | Device | The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced. |
|
| Measure | Description | Time Frame |
|---|---|---|
| QRS Frequency at Each Paced Location | Time frequency analysis performed at each location | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
- Age less than 18 years
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Niebauer, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | QRS Frequency at Each Paced Location | Time frequency analysis performed at each location | Unable to collect or analyze the data. Study was not feasible. | Posted | Baseline |
|
Day of the index procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Neibauer | Cleveland Clinic | 216-444-3160 | niebaum@ccf.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2017 | Nov 23, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 9, 2017 | Nov 23, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Nonrandomized survey of different pacing sites in the coronary veins.
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Need for implantation of a left ventricular pacing lead via the coronary sinus branch beins | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
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