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Purpose

Prospective, multi-center, single arm, post approval study to be conducted in the United States.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Subjects who received de novo implantation of BSC's Resonate family of CRT-D devices with the LV MSP feature4 and BSC's ACUITYTM X4 LV Quadripolar leads. A Resonate family of CRT-D device upgrade from previous single or dual chamber pacemaker or ICD implantation is allowed. 2. Subjects must meet BSC labeled indication for CRT-D implantation. 3. Subjects must have a functional RA lead and RV lead implanted 4. Subjects who are willing and capable of providing informed consent 5. Subjects who are willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol 6. Subjects who are age 18 and above, or of legal age to give informed consent specific to state and national law

Exclusion Criteria

  1. Subjects who received LV pacing prior to receiving the Resonate family of CRT-D system implantation. 2. Subjects who received the LV MSP therapy post CRT-D implantation but prior to enrollment 3. Subjects with documented history of permanent AF 4. Subjects with documented permanent complete AV block 5. Subjects who are expected to receive a heart transplant during the 12 months course of the study 6. Subjects with documented life expectancy of less than 12 months 7. Subjects who enrolled in any other concurrent study or registry, with the exception of mandatory national or governmental registry, without prior written approval from BSC

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Single Arm 		General population who receive a Boston Scientific Resonate family of CRT-D device in accordance with its labeled indication for use.
  • Device: CRT-D
    Left Ventricular MultiSite Pacing

More Details

Status
Completed
Sponsor
Boston Scientific Corporation

Study Contact

Detailed Description

Evaluate the effectiveness of Boston Scientific (BSC)'s LV MSP (Left Ventricular MultiSite Pacing) feature in the Resonate family of CRT-D devices and confirm safety in a post approval study when used in accordance with its approved labeling.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.