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

Status unconfirmed · Not applicable

Conditions studied: Heart Failure (NYHA Class III and Ambulatory IV)

In brief

The objective of the Continued Access study is to gather confirmatory evidence on the safety of the SonRtip lead and performance 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 a patient population that is reflective of current heart failure treatment practice.

Key facts

Study ID

NCT02374801

Run by

MicroPort CRM

People needed

49

Starts

2015-04-01

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…

• Patients who meet all the following criteria at the time of enrollment may be included:
• Patient with a class I and IIa indication for implantation of a CRT-D device according to current available guidelines
• Moderate/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 signing the informed consent
• Signed and dated informed consent

You may not qualify if…

• Patients who meet any one of these criteria will be excluded from the investigation:
• 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 enrollment
• Incessant ventricular tachyarrhythmia
• Unstable angina, or 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- P or CRT-D device
• Concurrent implant with another pacemaker or ICD system in which all or some of the components will not be extracted and/or utilized in the new system. Previously implanted RA leads must be removed prior to implant of the SonRtip lead.
• 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
• Substance addiction or abuse
• Under guardianship

Where it is running

• University Hospitals of Cleveland — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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