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

Status unconfirmed · Phase 3

Conditions studied: Heart Failure NYHA Class III and Ambulatory IV

In brief

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.

Key facts

Study ID

NCT01534234

Run by

MicroPort CRM

People needed

1039

Starts

2012-01-01

Expected to finish

2019-12-01

Last updated by the study team

2019-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient eligible with class I and IIa indication for implantation of a CRT-D device according to current available guidelines ;
• Modere,Severe HF (NYHA Class III or ambulatory IV)
• LVEF ≤ 35 %
• LBBB: QRS ≥ 120 ms ; non-LBBB : QRS ≥ 150 ms
• On a stable, optimal drug regimen
• Patient is in sinus rhythm at the time of enrollment;
• Signed and dated informed consent

You may not qualify if…

• 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;
• Incessant ventricular tachyarrhythmia;
• Unstable angina, or acute MI, CABG, or PTCA within the past 4 weeks;
• Correctable valvular disease that is the primary cause of heart failure;
• Recent CVA or TIA (within the previous 3 months);
• Persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
• Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
• Renal failure (GFR<15 ml/min/1.73m2) or on dialysis
• Previous implant with a CRT/CRT-D device;
• 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);
• Already included in another clinical study that could confound the results of this study;
• Life expectancy less than 1 year;
• Inability to understand the purpose of the study or to understand and complete the QOL questionnaire;
• Unavailability for scheduled follow-up or refusal to cooperate;
• Sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
• Age of less than 18 years;
• Pregnancy
• Drug addiction or abuse
• Under guardianship

Where it is running

• AZ Heart Rhythm Center — Phoenix, Arizona, United States
• Brotman Medical Center — Culver City, California, United States
• Hoag Hospital — Newport Beach, California, United States
• Scripps Mercy Hospital — San Diego, California, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• St. Vincent's HealthCare — Jacksonville, Florida, United States
• Piedmont Hospital Research Institute — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Swedish Covenant Hospital — Chicago, Illinois, United States
• The University of Chicago Medicine Hospital — Chicago, Illinois, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Massachusetts General Hospital-CAS — Boston, Massachusetts, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Rutgers New Jersey Medical School — Newark, New Jersey, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• New York Presbyterian — New York, New York, United States
• Rochester General Hospital — Rochester, New York, United States
• Forsyth Hospital — Winston-Salem, North Carolina, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• St. Francis Hospital — Tulsa, Oklahoma, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Hospital of the University of PA — Philadelphia, Pennsylvania, United States
• Brookwood Medical Center CardioVascular Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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