Post Market Surveillance Study Following Clinical Routine Clinical Trial
— Rally CRT-POfficial title:
Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
NCT number | NCT02488239 |
Other study ID # | Rally-CRT-P-02-2015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | March 2017 |
Verified date | March 2019 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 18 years or above, or above legal age to give informed consent specific to state and national law 2. Willing and capable of providing informed consent 3. Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device 4. Planned to be implanted with a 3-lead CRT-P system 5. Planned to be connected to the remote data collection through the Latitude® system 6. Able to do a 6 minute walk test 7. Maximum sensor rate of age predicted maximal heart rate (APMHR) 80% should be clinically acceptable 8. 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: 1. Documented life expectancy of less than 12 months 2. Currently on the active heart transplant list 3. 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 4. In chronic atrial fibrillation 5. APMHR needs to be programmed < 80%. 6. Not planned to receive a functional atrial lead 7. Per the implanting physician's discretion, subject is not a suitable candidate to receive the study device as determined during the implant procedure 8. Women of childbearing potential who are or might be pregnant at the time of study enrollment 9. Unwilling or unable to participate in all scheduled study follow up visits at an approved study center 10. Does not anticipate being a resident of the area for the scheduled duration of the trial. - |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Central Hospital | Helsinki | |
Finland | Tampere University Hospital | Tampere | |
Germany | Unfallkrankenhaus Berlin | Berlin | |
Germany | Herz-und Gefäßzentrum Göttingen | Göttingen | |
Germany | Krankenhaus Landshut-Achdorf | Landshut | |
Germany | University Magdeburg | Magdeburg | |
Germany | Klinikum Oldenburg | Oldenburg | |
Germany | Harzklinikum Quedlinburg | Quedlinburg |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation | ICON plc |
Finland, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Without CRT-P Device Related Complications | 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. | 3 months post-implant | |
Primary | LV Pacing Threshold | Primary Effectiveness endpoint: evaluation of the left ventricular pacing threshold measurements performed at 0.5 ms pulse width at 3 months post-implant. | 3 months post-implant |