IP Library › Granted Patent US 10,408,845
Granted Patent B2
US 10,408,845 · App. 15/370,049 · Granted Sep 10, 2019

Methods for treating or predicting risk of a ventricular tachyarrhythmia event

Inventors: James V. Snider (San Diego, CA); Timothy Edward Meyer (North Oaks, MN); Craig Michael Stolen (New Brighton, MN); Robert W. Gerwien (Newington, CT)
Assignees: Critical Care Diagnostics, Inc.; Cardiac Pacemakers, Inc.
G01N33/6887A61B5/7275A61N1/3627A61N1/3956G01N33/6893G01N2333/7155G01N2800/325G01N2800/326G01N2800/50
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Quick Facts
Patent No.
US 10,408,845
App. No.
15/370,049
Granted
Sep 10, 2019
Kind
B2
Abstract

Provided herein are methods that include (i) determining a level of soluble ST2 in a biological sample from a subject, (i) comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2 (e.g., a level of soluble ST2 in the subject at an earlier time point), and (iii) selecting, implanting, replacing, or reprogramming an implanted cardiac device, e.g., an ICD, CRT, or CRT-D device, for a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2, or selecting a subject for participation in, or stratifying a subject participating in, a clinical study of a treatment for reducing the risk of a ventricular tachyarrhythmia (VTA) event. Also provided are methods for evaluating the risk of a VTA event in a subject. Also provided are kits for performing any of these methods.

Claims (26)

1. A method for selecting a treatment for a subject having heart failure to reduce the risk of a ventricular tachyarrhythmia (VTA) event, the method comprising:

determining a level of soluble ST2 in a biological sample comprising blood, serum or plasma from a subject having heart failure;

comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2;

identifying a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2 as being more likely to benefit from implantation of an implantable cardiac defibrillator (ICD), a cardiac resynchronization therapy device (CRT), or a combination cardiac resynchronization therapy defibrillator device (CRT-D); and

selecting an ICD, a CRT, or a CRT-D for the identified subject.

2. The method of claim 1 , wherein the subject has previously had at least one ventricular tachyarrhythmia event.

3. The method of claim 1 , wherein the reference level of soluble ST2 is a level of soluble ST2 in a healthy subject.

4. A method of treating a subject having heart failure to reduce the risk of a ventricular tachyarrhythmia (VTA) event, the method comprising:

determining a level of soluble ST2 in a biological sample comprising blood, serum, or plasma from a subject having heart failure;

comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2;

identifying a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2 as being more likely to benefit from implantation of an implantable cardiac defibrillator (ICD), a cardiac resynchronization therapy device (CRT), or a combination cardiac resynchronization therapy defibrillator device (CRT-D); and

implanting an ICD, a CRT, or a CRT-D device into the identified subject, or replacing or reprogramming an implanted ICD, CRT, or CRT-D in the identified subject.

5. The method of claim 4 , wherein the subject has previously had at least one ventricular tachyarrhythmia event.

6. The method of claim 4 , wherein the reference level of soluble ST2 is a level of soluble ST2 in a healthy subject.

7. The method of claim 1 , wherein the method comprises selecting an ICD for the identified subject.

8. The method of claim 1 , wherein the method comprises selecting a CRT for the identified subject.

9. The method of claim 1 , wherein the method comprises selecting a CRT-D for the identified subject.

10. The method of claim 4 , wherein the method comprises implanting an ICD into the identified subject.

11. The method of claim 4 , wherein the method comprises implanting a CRT into the identified subject.

12. The method of claim 4 , wherein the method comprises implanting a CRT-D into the identified subject.

13. The method of claim 4 , wherein the method comprises replacing an implanted ICD in the identified subject.

14. The method of claim 4 , wherein the method comprises replacing an implanted CRT in the identified subject.

15. The method of claim 4 , wherein the method comprises replacing an implanted CRT-D in the identified subject.

16. The method of claim 4 , wherein the method comprises reprogramming an implanted ICD in the identified subject.

17. The method of claim 4 , wherein the method comprises reprogramming an implanted CRT in the identified subject.

18. The method of claim 4 , wherein the method comprises reprogramming an implanted CRT-D in the identified subject.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2017
From: SNIDER, JAMES V.; GERWIEN, ROBERT W.
To: CRITICAL CARE DIAGNOSTICS, INC.
Reel/Frame 042611/0464 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2017
From: MEYER, TIMOTHY EDWARD; STOLEN, CRAIG MICHAEL
To: CARDIAC PACEMAKERS, INC.
Reel/Frame 042611/0520 →
Continuity (3)
Continuation 13897249 · May 17, 2013
Provisional Application 61649202 · May 18, 2012
Related Publication 20170146552A1 · May 25, 2017