Clinical trial NCT02488239: Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
Official title: Optimizing Pacing Therapy by Using Multi-Programmable Pulse Generators for Cardiac Resynchronization Pacing (CRT-P)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Market Surveillance Study Following Clinical Routine
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2015-07-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Planned to be implanted or replaced with a VISIONIST Ingenio 2 CRT-P device

The Ingenio 2 CRT-Ps are indicated for patients who have symptomatic congestive heart failure (CHF) including left ventricular (LV) dysfunction and wide QRS, and/or one or more of the following conditions:

Symptomatic paroxysmal or permanent second- or third-degree atrioventricular (AV) block Symptomatic bilateral bundle branch block Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial \[SA\] block) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Percentage of Participants Without CRT-P Device Related Complications
timeFrame: 3 months post-implant
measure: LV Pacing Threshold
timeFrame: 3 months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Göttingen
country: Germany
facility: Herz-und Gefäßzentrum Göttingen
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Magdeburg
country: Germany
facility: University Magdeburg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Quedlinburg
country: Germany
facility: Harzklinikum Quedlinburg
Study officials:
affiliation: Helsinki University Central Hospital
name: S. Pakarinen, Dr.
role: PRINCIPAL_INVESTIGATOR
References: