Bradycardia
Conditions
Brief summary
The objectives of this registry are to 1. Collect clinical data on Boston Scientific's ImageReady MR Conditional Pacing Systems involving the INGEVITY lead based on observations / events 2. Gather data on actual number of MRI scans performed in the patient cohort implanted with an ImageReady system including information about scanned body parts. 3. Collect physician feedback on lead handling with the INGEVITY lead in a real-life, market-released standard of care environment using devices on intended purpose and which are authorized to bear the CE (Communauté Européenne) marking / are approved for use in the applicable area of participating centers. No additional invasive or other burdensome examinations are to be carried out other than the ones conducted by the centers per their general standard of care.
Interventions
DEVICEImageReady MR Conditional Pacing System Implant
Implant according to standard-of-care. No study-specific interventions in that registry.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is willing and capable of providing informed consent and to give approval to collect / store / process personal health information by the sponsor * Subject is scheduled for, or implanted with, a clinically indicated BSC ImageReady system according to current and locally applicable implant guidelines such as published by European Society of Cardiology (ESC) / American Heart Association (AHA) / American College of Cardiology (ACC) / Hearth Rhythm Society (HRS) * Subject is geographically stable to be available for follow up at an approved registry center during the whole registry duration * Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
Exclusion criteria
* Existing contraindications for a BSC ImageReady system as mentioned in the applicable reference guides of the implanted system components including a known or suspected sensitivity to dexamethasone acetate (DXA) * Implanted pacing system is not ImageReady, i.e. any system components other than BSC INGEVITY MRI Conditional leads (or their market released successors), BSC INGENIO MRI family pacemaker models and their accessories (or their market released successors) intended to have MR Conditional status, including pre-existing abandoned leads of any kind still implanted and which will not be removed during the implant or re-implant procedure or plugged lead ports * Any existing conditions per local standard of care preventing the subject from undergoing an MRI procedure including implanted active or inactive medical devices / material, not considered MR Conditional * Subject is enrolled in any other concurrent study with the exception of local mandatory governmental registries and studies/registries that are not in conflict and do not affect the following: 1. GENTLE registry outcome (i.e. involve different implantable system components than required for participation in GENTLE or would affect ability to undergo MRI procedures); 2. Conduct of the GENTLE Registry per Good Clinical Practice (GCP)/ ISO (International Organization of Harmonization) 14155:2011/ local regulations as applicable * Subject is a woman of childbearing potential who is, or might be, pregnant at the time of registry enrollment or plans to become pregnant during the course of the registry (based on physician's assessment) * Estimated life expectancy of less than twelve months per physician discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Leads Free From Complication | 91 calendar days post-implant | Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. |
Other
| Measure | Time frame | Description |
|---|---|---|
| MRI Procedures Through 12 Months Post-Implant | 365 calendar days post implant | The percentage of subjects who underwent an MRI scan through 12 months post-implant. |
Countries
Austria, Belgium, France, Germany, Ireland, Italy, Norway, Portugal, South Korea, Spain, Sweden, Switzerland, United Kingdom
Participant flow
Recruitment details
Enrollment in the study began on 02 April 2014. The enrollment completion for the GENTLE study was communicated to the participating sites on 26 February 2016. However, additional subjects were enrolled after this date and the last subject signed consent on 08 March 2016. The last subject last visit was on 07 June 2016.
Pre-assignment details
1184 subjects signed the informed consent (IC). 4 subjects signed the IC only after the end of enrollment. 1180 subjects signed IC before the end of enrollment and are considered 'actively enrolled'. 1174 subjects met all eligibility criteria and were thus considered 'consent eligible' and were considered for the baseline.
Participants by arm
| Arm | Count |
|---|---|
| Pacemaker/Lead Implant All enrolled subjects will receive an ImageReady Magnet Resonant (MR) Conditional Pacing System and the treatment assignment will be based on an all-comers consecutive basis.
ImageReady MR Conditional Pacing System Implant: Implant according to standard-of-care.
No study-specific interventions in that registry. | 1,174 |
| Total | 1,174 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 31 |
| Overall Study | Device upgrade | 1 |
| Overall Study | Enrolled after End of Enrollment | 4 |
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 7 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Pacemaker/Lead Implant |
|---|---|
| Age, Continuous | 74.8 years STANDARD_DEVIATION 10.5 |
| Primary Brady Indication 1st degree AV block | 33 participants |
| Primary Brady Indication 2nd degree AV block | 247 participants |
| Primary Brady Indication 3rd degree AV block | 293 participants |
| Primary Brady Indication Chronotropic incompetence | 17 participants |
| Primary Brady Indication None | 0 participants |
| Primary Brady Indication Other | 192 participants |
| Primary Brady Indication Sinus arrest | 51 participants |
| Primary Brady Indication Sinus bradycardia | 92 participants |
| Primary Brady Indication Sinus node dysfunction | 249 participants |
| Region of Enrollment Austria | 38 participants |
| Region of Enrollment Belgium | 84 participants |
| Region of Enrollment France | 372 participants |
| Region of Enrollment Germany | 121 participants |
| Region of Enrollment Ireland | 45 participants |
| Region of Enrollment Italy | 208 participants |
| Region of Enrollment Norway | 16 participants |
| Region of Enrollment Portugal | 75 participants |
| Region of Enrollment South Korea | 20 participants |
| Region of Enrollment Spain | 170 participants |
| Region of Enrollment Sweden | 13 participants |
| Region of Enrollment Switzerland | 8 participants |
| Region of Enrollment United Kingdom | 4 participants |
| Sex: Female, Male Female | 413 Participants |
| Sex: Female, Male Male | 761 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 31 / 1,174 |
| other Total, other adverse events | 0 / 1,174 |
| serious Total, serious adverse events | 197 / 1,174 |
Outcome results
Primary
Percentage of Leads Free From Complication
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead.
Time frame: 91 calendar days post-implant
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pacemaker/Lead Implant | Percentage of Leads Free From Complication | 97.3 percentage of leads complication-free |
Other Pre-specified
MRI Procedures Through 12 Months Post-Implant
The percentage of subjects who underwent an MRI scan through 12 months post-implant.
Time frame: 365 calendar days post implant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pacemaker/Lead Implant | MRI Procedures Through 12 Months Post-Implant | 2.3 Percentage of subjects with MRI Scan |