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Low implant success rate(46%). For the successfull implants, 3month FU and available electrical data showed an increase in threshold values for the left atrium
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The purpose of this study is to evaluate the implant procedure and feasibility of a new lead developed to pace and sense the left chambers of the heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model 20105 | Experimental | Receiving the model 20105 Lead |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Model 20105 | Device | implant and follow-up of study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. | All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Teaching Hospital | London | Canada | ||||
| Reinier de Graaf Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Model 20105 | Receiving the model 20105 Lead Model 20105: implant and follow-up of study device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Model 20105 | Receiving the model 20105 Lead Model 20105: implant and follow-up of study device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | All Implant Procedure and Lead Related Adverse Events Will be Collected During the First Month Post Implant and Analyzed. | All Implant procedure and lead related adverse events will be collected during the first month post implant and analyzed. | all subject who underwent a Model 20105 Lead implant attempt are considered in this analysis | Posted | Number | Adverse Events | 1 month |
|
|
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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 | Model 20105 | Receiving the model 20105 Lead Model 20105: implant and follow-up of study device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Sinus Dissection | Injury, poisoning and procedural complications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Sinus Dissection | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study manager | Medtronic Regional Clinical Center | 0039(0)22 241371 | laura.manotta@medtronic.com |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Delft |
| Netherlands |
| NUHCS, National University Hospital | Singapore | Singapore |
| Milpark hospital | Johannesburg | South Africa |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| QRS duration | Mean | Standard Deviation | msec |
|
|
|
| 3 |
| 13 |
| 3 |
| 13 |
| Iatrogenic pneumothorax | Injury, poisoning and procedural complications |
|
| Coronary Artery Stent Insertion | Surgical and medical procedures |
|
| Atrioventricular nodal reentrant tachycardia | Cardiac disorders |
|
| Angina Pectoris | Cardiac disorders |
|
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| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |