Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)

Completed

Conditions: Post Market Surveillance Study Following Clinical Routine

Interventions: Device: CRT-P indicated patients

Registration Number: NCT02488239

Lead Sponsor: Boston Scientific Corporation

Brief Summary: The objective of this Post Market Clinical Follow-up (PMCF) is to collect data on the performance of the Ingenio 2 CRT-P devices and to document that device-related events, device malfunctions or device deficiencies (DDs) do not increase safety risks in Ingenio 2 CRT-P devices (CRT-Ps), both in general and specific to the new features and hardware of the devices.

Detailed Description: Prospective, non-randomized, multi-center, single group, post market clinical study The devices are fully commercially available and all subjects are planned to receive a CRT-P implant as part of their standard of care (SOC). The assignment of the specific Ingenio 2 device is physician's choice and will consider leads currently in place from previous devices and planned new leads (e.g., Acuity X4 and/or other LV leads).

Enrollment and Consenting Clinic Visit (≤ 30 days prior to implant procedure) (required)

* Implant Procedure (Day 0; all future follow ups based on this date) (required)

* Pre-Discharge Clinic Visit (after pocket closure and wound coverage 0-5 days post-implant procedure) (required)

* 1 month post-implant Clinic Visit (30 ± 15 days) (required)

* 3 month post-implant Clinic Visit (91 ± 21 days) (required)

* Latitude-based Close-out (91 - 120 days months post last enrollment) (reporting only required)

* Unscheduled clinic follow-up (any clinic visit between pre-discharge and 3 month follow up which is in addition to the 1 month follow up; per center SOC or subject needs; event reporting only)

* Re-implant/Revision (as needed)

* During the trial unanticipated serious adverse device effects (USADEs), serious adverse device effects (SADEs), adverse device effects (ADEs), DDs, all serious adverse events (SAEs), deaths, and changes in the device system must be reported (enrollment to Closeout).

Study Duration Enrollment is expected to take 12 months. The study will be considered complete (primary endpoint completion) after all subjects have completed the Latitude based close-out 3-4 months after the last study enrollment. All study required visits will be completed as part of regularly scheduled clinic visits.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 64

Inclusion Criteria

18 years or above, or above legal age to give informed consent specific to state and national law
Willing and capable of providing informed consent
Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device
Planned to be implanted with a 3-lead CRT-P system
Planned to be connected to the remote data collection through the Latitude® system
Able to do a 6 minute walk test
Maximum sensor rate of age predicted maximal heart rate (APMHR) 80% should be clinically acceptable
Willing and capable of participating in all visits associated with this study at an approved clinical study center and at the intervals defined-

Exclusion Criteria

Documented life expectancy of less than 12 months
Currently on the active heart transplant list
Enrolled in any other concurrent study without prior written approval from Boston Scientific, with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- Schedule of procedures for the Rally CRT-P Study (i.e., should not cause additional or missed visits)
- Rally CRT-P Study outcomes (i.e., involve medications that could affect the heart rate of the subject)
- Conduct of the Rally CRT-P Study per Good Clinical Practice (GCP)/ International Standard Organization (ISO) 14155:2011/ local regulations as applicable
In chronic atrial fibrillation
APMHR needs to be programmed < 80%.
Not planned to receive a functional atrial lead
Per the implanting physician's discretion, subject is not a suitable candidate to receive the study device as determined during the implant procedure
Women of childbearing potential who are or might be pregnant at the time of study enrollment
Unwilling or unable to participate in all scheduled study follow up visits at an approved study center
Does not anticipate being a resident of the area for the scheduled duration of the trial. -

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT-P indicated patients	CRT-P indicated patients	Planned to be implanted with a 3-lead CRT-P system and connected to the remote data collection through the Latitude® system

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Without CRT-P Device Related Complications	3 months post-implant	Evaluate the Device-Related Complication Free Rate (DRCFR) at 3 months post-implant, which was based on complications that were related to the CRT-P device. A device-related complication was an adverse event that resulted in death, serious injury, a correction using invasive intervention or permanent loss of device functions, and that was assessed as related to the device.
LV Pacing Threshold	3 months post-implant	Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (8): Herz-und Gefäßzentrum Göttingen
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Göttingen, Germany
Unfallkrankenhaus Berlin
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Berlin, Germany
Krankenhaus Landshut-Achdorf
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Landshut, Germany
Harzklinikum Quedlinburg
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Quedlinburg, Germany
Klinikum Oldenburg
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Oldenburg, Germany
University Magdeburg
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Magdeburg, Germany
Helsinki University Central Hospital
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Helsinki, Finland
Tampere University Hospital
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Tampere, Finland