|Principal Investigator: Benjamin Steinberg|
|Keywords: Pacing , CRT-D , Heart Disease , Heart Failure , Cardiomyopathy , Conduction Disorder , Cardiovascular Disease , Ventricular Dysfunction , LV Dysfunction||Department: Cardiovascular Medicine|
|IRB Number: 00107677||Co Investigator: Mihail Chelu|
|Specialty: Cardiology, Cardiology, Cardiology|
|Sub Specialties: Heart Failure, Cardiac Electrophysiology|
|Recruitment Status: Active, not recruiting|
The objective of the study is to evaluate the effectiveness of the Boston Scientific’s LV MSP
feature in the BSC’s Resonate family of CRT-D devices, and confirm safety in a post
approval study when used in accordance with its approved labeling.
9.1. Study Population and Eligibility
Subjects included in the SMART MSP Study should be selected from the investigator’s
general patient population who received BSC Resonate family of CRT-D devices, and were
indicated for CRT-D implantation per BSC labeled indication provided in Section 9.1.1.
Investigators are responsible for screening all potential subjects and selecting those who meet
the eligibility criteria for the study as described in Sections 9.2 and Section 9.3 below.
9.1.1. BSC Labeled Indication for CRT-D Implantation
The BSC’s CRT-Ds are indicated for patients with heart failure who receive stable optimal
pharmacologic therapy (OPT) for heart failure and who meet any one of the following
• Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS
duration ≥ 120 ms
• Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild
(NYHA Class II) ischemic or non-ischemic heart failure or asymptomatic (NYHA
Class I) ischemic heart failure
9.2. Inclusion Criteria
Subjects who meet all of the following criteria (see Table 9.2-1) may be given consideration for inclusion in this clinical investigation, provided no exclusion criterion (see Section 9.3) is met.
Table 9.2-1: 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
9.3. Exclusion Criteria
Subjects who meet any one of the following criteria in Table 9.3-1 will be excluded from
this clinical study.
Table 9.3-1: 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. Women of childbearing potential who are pregnant or plan to become
pregnant over the course of the clinical trial. Note: For patients with
uncertain pregnancy status, pregnancy tests should have been
performed per site’s standard clinical practice prior to CRT-D device
8. 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