Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:January 2012
End Date:December 2019

Use our guide to learn which trials are right for you!

The objective of this study is to assess the safety and effectiveness of the automatic
atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in
the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device
(Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of
the atrial pacing lead, and compatible SmartView programming software.

This study will evaluate the effectiveness of the automatic optimization algorithm in
increasing the rate of patients responding to the therapy as compared to an echocardiographic
optimization method.

This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead.

Since the introduction of cardiac resynchronization therapy (CRT) on a large scale, it has
been observed that approximately 30% of recipient patients are non-responsive to therapy.
This non-responsiveness can be decreased by optimizing the device programming, particularly
the stimulation rate, paced and sensed atrioventricular (AV) delay, and the interventricular
(VV) delay.

All CRT patients need a 100% rate of ventricular capture, but beyond this the achievement of
therapy effectiveness requires the identification of the optimal pacing configuration, which
varies among patients. The optimization of CRT systems, usually based on ultrasound imaging
is time-consuming and the number of patients in need of multiple optimization procedures due
to ventricular remodeling is growing rapidly.

The mechanical effects of a more coordinated contraction result in a shortening of the
isovolumetric contraction phase and the pre-ejection time, and an increase in LV dP/dt
(change in left ventricular pressure over time. The concept of measuring contractility with
an implantable accelerometer was first clinically validated through a multicenter study on a
rate responsive pacing system (BEST - Living from SORIN Biomedica) in 1996. This study
positively demonstrates that measurement of Peak Endocardial Acceleration signal (called PEA
or SonR) is feasible and reliable in the long-term, both for the purpose of rate response and
as a hemodynamic monitor of cardiac function.

More recent clinical studies have demonstrated that optimal VV and AV Delays determined using
algorithms based on SonR signal analysis (SonR method) are correlated with the highest
hemodynamic improvement and lead to significant clinical benefit for the patients, thus
reducing the rate of non-responsiveness to CRT therapy.

Therefore, automatic AV and VV delay optimization in patients with CRT devices could benefit
both the patient and physician.

Inclusion Criteria:

1. Patient eligible with class I and IIa indication for implantation of a CRT-D device
according to current available guidelines ;

2. Modere,Severe HF (NYHA Class III or ambulatory IV)

3. LVEF ≤ 35 %

4. LBBB: QRS ≥ 120 ms ; non-LBBB : QRS ≥ 150 ms

5. On a stable, optimal drug regimen

6. Patient is in sinus rhythm at the time of enrollment;

7. Signed and dated informed consent

Exclusion Criteria:

1. Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial
infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance,
hypoxia or sepsis, uncorrected at the time of the enrolment;

2. Incessant ventricular tachyarrhythmia;

3. Unstable angina, or acute MI, CABG, or PTCA within the past 4 weeks;

4. Correctable valvular disease that is the primary cause of heart failure;

5. Recent CVA or TIA (within the previous 3 months);

6. Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation)
within the past month;

7. Post heart transplant (patients who are waiting for a heart transplant are allowed in
the study);

8. Renal failure (GFR<15 ml/min/1.73m2) or on dialysis

9. Previous implant with a CRT/CRT-D device;

10. Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or
ICD devices or RA leads should be removed prior to implant with the Paradym RF SONR
CRT-D);

11. Already included in another clinical study that could confound the results of this
study;

12. Life expectancy less than 1 year;

13. Inability to understand the purpose of the study or to understand and complete the QOL
questionnaire;

14. Unavailability for scheduled follow-up or refusal to cooperate;

15. Sensitivity to 1 mg dexamethasone sodium phosphate (DSP)

16. Age of less than 18 years;

17. Pregnancy

18. Drug addiction or abuse

19. Under guardianship
We found this trial at
32
sites
Atlanta, Georgia 30309
1918
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
2035
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
1111 Amsterdam Ave
New York, New York 10025
(212) 523-4000
St Luke's - Roosevelt Hospital Center With 523 beds, Mount Sinai St. Luke's serves as...
2434
mi
from 91732
New York, NY
Click here to add this to my saved trials
3980 Colonnade Parkway
Birmingham, Alabama 35243
1790
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts 02114
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
7198
mi
from 91732
Brisbane,
Click here to add this to my saved trials
Chicago, Illinois 60625
1727
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
5700 South Maryland Avenue
Chicago, Illinois 60637
1730
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
1726
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45220
1879
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
2036
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
Columbia, South Carolina 29204
2106
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
2106
mi
from 91732
Columbia, SC
Click here to add this to my saved trials
Culver City, California 90232
21
mi
from 91732
Culver City, CA
Click here to add this to my saved trials
Dallas, Texas 75216
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
1225
mi
from 91732
Dallas, TX
Click here to add this to my saved trials
555 East Cheves Street
Florence, South Carolina 29506
843-777-2000
McLeod Regional Medical Center McLeod Health, a regional presence and predominant healthcare organization, is dedicated...
2171
mi
from 91732
Florence, SC
Click here to add this to my saved trials
Fort Lauderdale, Florida 33316
2317
mi
from 91732
Fort Lauderdale, FL
Click here to add this to my saved trials
Fort Worth, Texas 76104
1195
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials
Jacksonville, Florida 32204
2130
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
Lansing, Michigan 48912
1891
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
New Orleans, Louisiana 70121
1650
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
273 Bleecker Street
New York, New York 10032
2432
mi
from 91732
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07103
2422
mi
from 91732
Newark, NJ
Click here to add this to my saved trials
Newport Beach, California 92658
31
mi
from 91732
Newport Beach, CA
Click here to add this to my saved trials
2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
Rochester, New York 14621
2246
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
San Diego, California 92103
103
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
Tulsa, Oklahoma 74136
?
mi
from 91732
Tulsa, OK
Click here to add this to my saved trials
Winston-Salem, North Carolina 27103
2123
mi
from 91732
Winston-Salem, NC
Click here to add this to my saved trials