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

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.

Study Overview

• Status: Completed
• Conditions: Post Market Surveillance Study Following Clinical Routine
• Intervention / Treatment: Device: CRT-P indicated patients

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.

• Study Type: Observational
• Enrollment (Actual): 64

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00029
    • Helsinki University Central Hospital
  • Tampere, Finland, 33521
    • Tampere University Hospital
• Germany
  • Berlin, Germany, 12683
    • Unfallkrankenhaus Berlin
  • Göttingen, Germany, 37073
    • Herz-und Gefäßzentrum Göttingen
  • Landshut, Germany, 84036
    • Krankenhaus Landshut-Achdorf
  • Magdeburg, Germany, 39120
    • University Magdeburg
  • Oldenburg, Germany, 26133
    • Klinikum Oldenburg
  • Quedlinburg, Germany, 06484
    • Harzklinikum Quedlinburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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. -

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: CRT-P indicated patients; Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device; Other Names: Pacemaker implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: ICON plc
• Investigators: Principal Investigator: S. Pakarinen, Dr., Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Rally-CRT-P-02-2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No