Bradyarrhythmia
Conditions
Keywords
Pacing lead, implant, pacemaker
Brief summary
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.
Interventions
DEVICEPacing system implant with the CapsureFix MRI pacing lead model 5086
Pacing system implant with the CapsureFix MRI pacing lead model 5086
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient older than 18 * Patient implanted with a fully automatic ICD and remotely followed-up, * Patient geographically stable and able to attend FU at investigative site * Patient who signed a data release authorization form,
Exclusion criteria
* Patient whose mental or physical capacity impedes to give an informed data release authorization, * Patient already enrolled in a clinical study whose procedures may interfere with the results of the present study, * Patients in New York Heart Association (NYHA) class IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Implant | at 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. |
| Lead Stability | 3 months | Lead stability of the Capsure Fix as measured by number of dislodgments |
| Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | 3 months | Change of pacing threshold will be measured during and post implant of the CapsureFix MRI lead model 5086 |
| Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | 3 months | Change of sensing amplitude will be measured during and post implant of the CapsureFix MRI Lead Model 5086 |
| Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | 3 months | Change of impedance will be measured during and post implant of the CapsureFix MRI Lead Model 5086 |
Countries
France
Participant flow
Recruitment details
Recruitment period: 31 January 2010 - 24 January 2013. 32 implanting centers and 41 implanters participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Patients Implanted With the CapsureFix MRI Pacing Lead Patients implanted with the CapsureFix MRI pacing lead model 5086 | 409 |
| Total | 409 |
Baseline characteristics
| Characteristic | Patients Implanted With the CapsureFix MRI Pacing Lead |
|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 10.7 |
| Atrial arrhythmia history Patients with atrial arrhythmia history | 126 participants |
| Atrial arrhythmia history Patients with no atrial arrythmia history | 283 participants |
| cardiac disease history Patients with cardiac disease history | 95 participants |
| cardiac disease history Patient with no cardiac disease history | 314 participants |
| coronary disease history Patients with coronary disease history | 59 participants |
| coronary disease history Patients with no coronary disease history | 350 participants |
| Myocardial infarction history Patients with myocardial infarction history | 28 participants |
| Myocardial infarction history Patients with no myocardial infarction history | 381 participants |
| Pacing indication 1st degree AV block | 21 participants |
| Pacing indication 2nd degree AV block Mobitz 2 | 62 participants |
| Pacing indication 2nd degree AV block Wenckebach | 19 participants |
| Pacing indication Other | 18 participants |
| Pacing indication Paroxysmal 3rd degree AV block | 57 participants |
| Pacing indication Permanent 3rd degree AV block | 59 participants |
| Pacing indication Sinoatrial block | 40 participants |
| Pacing indication Sinus bradycardia | 51 participants |
| Pacing indication Sinus node disease | 82 participants |
| Region of Enrollment France | 409 participants |
| Sex: Female, Male Female | 151 Participants |
| Sex: Female, Male Male | 258 Participants |
| Stroke history Patients with no stroke history | 372 participants |
| Stroke history Patients with stroke history | 37 participants |
| Ventricular arrhythmia history Patients with no ventricular arrhythmia history | 395 participants |
| Ventricular arrhythmia history Patients with ventricular arrhytmia history | 14 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 409 |
| serious Total, serious adverse events | 16 / 409 |
Outcome results
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.
Time frame: at implant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanting Physicians | Ease of Implant | maneuverability for the atrium | 6.9 score on a scale | Standard Deviation 1.2 |
| Implanting Physicians | Ease of Implant | maneuverability for the ventricle | 6.3 score on a scale | Standard Deviation 1 |
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
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanting Physicians | Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | Impedance Implant RA | 704 Ohm | Standard Deviation 242 |
| Implanting Physicians | Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | Impedance Post Implant RA | 547 Ohm | Standard Deviation 175 |
| Implanting Physicians | Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | Impedance Implant RV | 896 Ohm | Standard Deviation 286 |
| Implanting Physicians | Impedance Measurements During and Post Implant of the CapsureFix MRI Lead Model 5086 | Impendance Post Implant RV | 635 Ohm | Standard Deviation 200 |
p-value: <0.05t-test, 2 sided
Primary
Lead Stability
Lead stability of the Capsure Fix as measured by number of dislodgments
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Implanting Physicians | Lead Stability | 10 dislodgements |
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
Time frame: 3 months
Population: 409 patients have been consecutively enrolled in 32 sites.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanting Physicians | Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | Pacing threshold Implant (RA) | 0.9 Volt | Standard Deviation 0.5 |
| Implanting Physicians | Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | Pacing threshold Post implant (RA) | 0.6 Volt | Standard Deviation 0.3 |
| Implanting Physicians | Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | Pacing threshold Implant (RV) | 0.7 Volt | Standard Deviation 0.4 |
| Implanting Physicians | Pacing Threshold During and Post Implant of the CapsureFix MRI Lead Model 5086 | Pacing threshold Post implant (RV) | 0.6 Volt | Standard Deviation 0.3 |
p-value: <0.05t-test, 2 sided
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
Time frame: 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implanting Physicians | Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | Sensing Implant (RA) | 3.2 mV | Standard Deviation 1.9 |
| Implanting Physicians | Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | Sensing Post Implant (RA) | 3.2 mV | Standard Deviation 2.2 |
| Implanting Physicians | Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | Sensing Implant (RV) | 10.9 mV | Standard Deviation 5.2 |
| Implanting Physicians | Sensing Amplitude During and Post Implant of the CapsureFix MRI Lead Model 5086 | Sensing Post Implant (RV) | 9.5 mV | Standard Deviation 4.5 |
p-value: <0.05t-test, 2 sided