Overview

This trial is active, not recruiting.

Condition heart failure nyha class iii and ambulatory iv
Treatments paradym rf sonr
Phase phase 3
Sponsor Sorin Group
Start date January 2012
End date December 2015
Trial size 1039 participants
Trial identifier NCT01534234, ITSY06 - RESPOND CRT

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
SonR CRT Optimization
paradym rf sonr
SonR CRT Optimization
(Other)
Echocardiographic Optimization
paradym rf sonr
Echocardiography Optimization

Primary Outcomes

Measure
Evaluation of SonR CRT Optimization Effectiveness in terms of proportion of responders at 12 months. The investigational(SonR)and control groups(ECHO)will be compared in a non-inferiority context employing a clinically meaningful difference of 10%.
time frame: 12 months
Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months)
time frame: 3 months
Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months)
time frame: 12 months

Secondary Outcomes

Measure
Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 12 months
time frame: 12 months
Evaluation of CRT effectiveness and CRT therapy: Proportion of patients worsened at 12 months
time frame: 12 months
SonR tip lead pacing threshold
time frame: 24 months
SonR tip lead sensing threshold
time frame: 24 months
SonR tip lead pacing impedance
time frame: 24 months
Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause
time frame: 24 months
Report Heart Failure-related events to assess CRT effectiveness
time frame: 24 months
Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL)
time frame: 24 months
Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class)
time frame: 24 months
Evaluation of CRT effectiveness: Report echocardiographic parameters trend at M12
time frame: 12 months
Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group
time frame: 18/24 months
Evaluation of the time spent for CRT optimization by the physician on optimization in each group (sonR and ECHO)
time frame: 24 months
Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO)
time frame: 24 months
Report Adverse Events for both group to assess CRT effectiveness / System Safety
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Principal investigator Josep BRUGADA
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Sorin Group.