N/A
N=64
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
Post Market Surveillance Study Following Clinical Routine
Bottom Line
View on ClinicalTrials.gov: NCT02488239 ↗Enrolled (actual)
64
Serious AEs
32.8%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Participants Without CRT-P Device Related Complications — 100 % of participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CRT-P indicated patients (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Without CRT-P Device Related Complications |
100 | <0.001 sig |
| PRIMARY LV Pacing Threshold |
1.65 | <0.001 sig |
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.
Eligibility Criteria
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. -
Data sourced from ClinicalTrials.gov (NCT02488239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.