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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Pacing leads are key elements of a pacing system as their proper functioning is one of the major factors affecting the long term performance of the whole system.
Success of a pacing lead implant can be defined considering 3 items: ease of lead implant, lead stability and lead electrical performances.
These factors may be related to the physician experience (global implant experience, experience with a given lead), to the implant procedure (lead access, lead position, implant time, scopy time) to the lead (handling and mechanical characteristics) and to the patient (ischemic history).
Even though implant success rate is quite high with currently available leads, the weight of the different factors influencing success has never been studied systematically. The objective of the current study is then to define the predictive factors of an implant success with the CapsureFix MRI model 5086.
This lead has been selected because it has been available for a short period, so the investigators have a limited experience of it and it has a unique design which makes it conditionally safe in an MRI environment and which may be associated with specific handling characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted with the CapsureFix MRI pacing lead | Patients implanted with the CapsureFix MRI pacing lead model 5086 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacing system implant with the CapsureFix MRI pacing lead model 5086 | Device | Pacing system implant with the CapsureFix MRI pacing lead model 5086 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Implant | Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site. | at implant |
| Lead Stability | Lead stability of the Capsure Fix as measured by number of dislodgments | 3 months |
| Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086 | 3 months |
| Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086 | 3 months |
| Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patient implanted with 2 CapsureFix MRI pacing leads model 5086 in the atrium and in the ventricle
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| Name | Affiliation | Role |
|---|---|---|
| Olivier BIZEAU, MD | Centre Hospitalier Regionnal d'Orléans La Source | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regionnal d'Orléans La Source | Orléans | 45067 | France |
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Recruitment period: 31 January 2010 - 24 January 2013. 32 implanting centers and 41 implanters participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Implanted With the CapsureFix MRI Pacing Lead | Patients implanted with the CapsureFix MRI pacing lead model 5086 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Implanted With the CapsureFix MRI Pacing Lead | Patients implanted with the CapsureFix MRI pacing lead model 5086 |
| 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 | Ease of Implant | Ease of implant as experienced by the implanting physician on maneuverability of the catheter. This was measured by a questionnaire for which each criterion was coded as Very Good, Good, Fair, Poor, Very Poor. Coding 9, 7, 5, 3, 1 was applied for each response with 9 representing Very Good. An average was calculated for each evaluation and for each probe implantation site. | Posted | Mean | Standard Deviation | score on a scale | at implant |
|
|
From the informed consent signature to the end of the study.
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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 | Patients Implanted With the CapsureFix MRI Pacing Lead | Patients implanted with the CapsureFix MRI pacing lead model 5086 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lead displacement | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| electrical abnormal parameters | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Foudali Latifa | Medtronic | +33 631992144 | latifa.foudali@medtronic.com |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pacing indication | Number | participants |
|
| Atrial arrhythmia history | Number | participants |
|
| Ventricular arrhythmia history | Number | participants |
|
| cardiac disease history | Number | participants |
|
| coronary disease history | Number | participants |
|
| Myocardial infarction history | Number | participants |
|
| Stroke history | Number | participants |
|
| Participants |
|
|
| Primary | Lead Stability | Lead stability of the Capsure Fix as measured by number of dislodgments | Posted | Number | dislodgements | 3 months |
|
|
|
| Primary | Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086 | 409 patients have been consecutively enrolled in 32 sites. | Posted | Mean | Standard Deviation | Volt | 3 months |
|
|
|
|
| Primary | Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086 | Posted | Mean | Standard Deviation | mV | 3 months |
|
|
|
|
| Primary | Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086 | Posted | Mean | Standard Deviation | Ohm | 3 months |
|
|
|
|
| 16 |
| 409 |
| 11 |
| 409 |
| hemopericardium | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Permanent disability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hospitalization due to electrical issue | Cardiac disorders | Non-systematic Assessment |
|
| lead displacement | Cardiac disorders | Non-systematic Assessment |
|
| pneumothorax | Cardiac disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Pacing threshold Post implant (RV) |
|
| Title | Measurements |
|---|
|
| Sensing Post Implant (RV) |
|
| Title | Measurements |
|---|
|
| Impendance Post Implant RV |
|