NCT02488239

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Market Surveillance Study Following Clinical Routine

Interventions

Type	Name	Description
DEVICE	CRT-P indicated patients	Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-07-02
• Last updated: 2019-09-20
• Results posted: 2019-09-20

Locations

8 sites across 2 countries: Finland, Germany