Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
- Conditions
- Heart Failure NYHA Class III and Ambulatory IV
- Interventions
- Device: PARADYM RF SONR
- Registration Number
- NCT01534234
- Lead Sponsor
- MicroPort CRM
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1039
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ECHO group PARADYM RF SONR Echocardiographic Optimization SonR group PARADYM RF SONR SonR CRT Optimization
- Primary Outcome Measures
Name Time Method 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%. 12 months The analysis will be done on all patients implanted with the entire system who have been followed out to 12 months. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure (HF) events,New York Heart association(NYHA) class), Quality of life (QOL).
In the event that the non-inferiority test is met, a test of superiority will be conducted comparing the treatment and control groups.Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months) 3 months SonRtip acute lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead within 3 months post-implant, relative to the total number of patients implanted with the lead.All patients who are successfully implanted with SonRtip lead will be included.
Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months) 12 months SonRtip lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead from 3 to 12 months post-implant.All patients who are successfully implanted with SonRtip lead will be included.
- Secondary Outcome Measures
Name Time Method SonR tip lead sensing threshold 24 months For all patients implanted with the SonRtip lead.
Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL) 24 months In all patients implanted the evaluation of the Quality of Life Score will consist of reporting the percentage of patients who showed improvement in their KCCQ Score at each follow-up post-implant
Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause 24 months The report of the deaths occurred consists of the percentage of dead patients, the causes of death, the time to death, the survival curves.
Report Heart Failure-related events to assess CRT effectiveness 24 months For all patients implanted it will be reported the percentage of patients with events, number of events for patients, event type, time to first occurence, survival curves)
Evaluation of CRT effectiveness: Report echocardiographic parameters trend at M12 12 months The intra-patient variations of the echocardiographic parameters measured at M12 as compared to those measured at baseline. The echo measures will be validated by an independent and blinded core lab
Report Adverse Events for both group to assess CRT effectiveness / System Safety 24 months For all patients enrolled all Adverse Events will be reported.
Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 12 months 12 months This endpoint will compare treatment arms in a non-inferiority hypothesis test of the proportion of subjects that either died from any cause, or were hospitalized for heart failure
Evaluation of CRT effectiveness and CRT therapy: Proportion of patients worsened at 12 months 12 months This endpoint will compare treatment arms in a non-inferiority hypothesis test of the proportion of subjects classified as worsened, in order to evaluate the potential detrimental effects of the optimization method
SonR tip lead pacing threshold 24 months For all patients implanted with the SonRtip lead.
SonR tip lead pacing impedance 24 months For all patients implanted with the SonRtip lead.
Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO) 24 months In all patients implanted will be evaluated the number of re-optimizations performed (mean, median, standard deviation, minimum, maximum) in each group (study and control).
Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class) 24 months In all patients implanted the evaluation of the NYHA Classification will consist of reporting the percentage of patients who improved at least one NYHA class at each follow-up post-implant
Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group 18/24 months The analysis will be done on all patients implanted with the entire system. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure events,NYHA class, Quality of life (QOL).
Evaluation of the time spent for CRT optimization by the physician on optimization in each group (sonR and ECHO) 24 months The amount of time (mean, median, standard deviation, minimum, maximum)in each group will be evaluated in all patients implanted
Trial Locations
- Locations (125)
Swedish Covenant Hospital
🇺🇸Chicago, Illinois, United States
Brotman Medical Center
🇺🇸Culver City, California, United States
CHRU de Lille,Hôpital Cardiologique
🇫🇷Lille, France
InParys CLINIQUE BIZET
🇫🇷Paris, France
Hospital of the University of PA
🇺🇸Philadelphia, Pennsylvania, United States
St. Vincent's HealthCare
🇺🇸Jacksonville, Florida, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
CH de Rangueil
🇫🇷Toulouse, France
Universitäts-Herzzentrum Freiburg
🇩🇪Freiburg, Germany
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Princess Alexandra Hospital
🇦🇺Brisbane, Australia
Plaza Medical Center of Fort Worth
🇺🇸Fort Worth, Texas, United States
St. Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
Massachusetts General Hospital-CAS
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
Institut Jacques Cartier
🇫🇷Massy, France
Krankenhaus Reinbek St. Adolf-Stift
🇩🇪Reinbek, Germany
Klinikum Magdeburg gemeinnützige GmbH
🇩🇪Magdeburg, Germany
CHU Charles Nicolle
🇫🇷Rouen, France
CHU - Hopital Nord
🇫🇷Saint Etienne, France
Chru Trousseau
🇫🇷Tours, France
Herz- und Diabeteszentrum Nordrhein-Westfalen
🇩🇪Bad Oeynhausen, Germany
St.-Marien-Hospital
🇩🇪Bonn, Germany
Hospital Virgen de Valme
🇪🇸Sevilla, Spain
H. Universitario Central de Asturias
🇪🇸Oviedo, Spain
Scripps Mercy Hospital
🇺🇸San Diego, California, United States
AZ Heart Rhythm Center
🇺🇸Phoenix, Arizona, United States
Piedmont Hospital Research Institute
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
St. Luke's Roosevelt Hospital Center
🇺🇸New York, New York, United States
New York Presbyterian
🇺🇸New York, New York, United States
Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
VA North Texas Health Care System
🇺🇸Dallas, Texas, United States
SMZ-Ost, 1 Medizinische Abteilung
🇦🇹Wien, Austria
Hôpital de la Cavale Blanche-CHU BREST
🇫🇷Brest, France
Centre Hospitalier Universitaire de La Timone
🇫🇷Marseille, France
CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque
🇫🇷Pessac, France
CH Poitiers
🇫🇷Poitiers, France
La Clinique du Tonkin
🇫🇷Villeurbanne, France
Herz- und Gefässzentrum Bad Bevensen
🇩🇪Bad Bevensen, Germany
Kerckhoff-Klinik GmbH
🇩🇪Bad Nauheim, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Universitätskliniken Bonn
🇩🇪Bonn, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
🇩🇪Frankfurt, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Universitätsklinikum Schleswig-HolsteinCampus Kiel
🇩🇪Kiel, Germany
Klinikum Ludwigshafen
🇩🇪Ludwigshafen, Germany
Klinikum Grosshadern
🇩🇪München, Germany
Universitätsklinik Münster Innere Medizin C
🇩🇪Münster, Germany
Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
🇮🇹Ancona, Italy
Azienda Ospedaliera S. Anna e S. Sebastiano
🇮🇹Caserta, Italy
AOU Ferrarotti-Alessi
🇮🇹Catania, Italy
Osp. Niguarda
🇮🇹Milan, Italy
Ospedale Civile
🇮🇹Mirano, Italy
SUN Ospedale Monaldi
🇮🇹Napoli, Italy
Osp. S. Maria della Misericordia
🇮🇹Rovigo, Italy
IRCCS Multimedica
🇮🇹Sesto San Giovanni, Italy
Slingeland Ziekenhuis
🇳🇱Doetinchem, Netherlands
Vlietland Ziekenhuis
🇳🇱Schiedam, Netherlands
Sint Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Ziekenhuis Bernhoven
🇳🇱Veghel, Netherlands
ISALA Klinieken
🇳🇱Zwolle, Netherlands
Centro Hospitalar do Porto CHP Hospital de Santo Antonio
🇵🇹Porto, Portugal
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinico de Barcelona
🇪🇸Barcelona, Spain
H. Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Puerta de Hierro
🇪🇸Majadahonda, Spain
Ospedale Civile Ss. Antonio E Biago
🇮🇹Alessandria, Italy
Ospedale Maurizio Bufalini
🇮🇹Cesena, Italy
Azienda Ospedaliera S. Croce E Carle
🇮🇹Cuneo, Italy
Azienda Osped-Universitaria CAREGGI
🇮🇹Firenze, Italy
Casa Di Cura Montevergine
🇮🇹Mercogliano, Italy
Fondazione Toscana Gabriele Monasterio
🇮🇹Pisa, Italy
A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U
🇮🇹Torino, Italy
A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera
🇮🇹Torino, Italy
Ospedale Cà Foncello
🇮🇹Treviso, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste
🇮🇹Trieste, Italy
Az. Osp. Univ. S. Maria della Misericordia
🇮🇹Udine, Italy
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Donostia
🇪🇸San Sebastian, Spain
Hospital Universitario Marques de Valdecilla Sur
🇪🇸Santander, Spain
H. General Universit.
🇪🇸Valencia, Spain
CHU VIGO
🇪🇸Vigo, Spain
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Papworth Everard
🇬🇧Cambridge, United Kingdom
Ashford and St. Peter's Hospitals NHS Trust
🇬🇧Chertsey, United Kingdom
Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T
🇬🇧Cottingham, United Kingdom
Genfield General Hospital
🇬🇧Leicester, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
CHU - Hopital Michallon
🇫🇷Grenoble, France
Nouvelles Cliniques Nantaises
🇫🇷Nantes, France
CHU Brabois
🇫🇷Vandoeuvre Les Nancy, France
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Wilhelminenspital
🇦🇹Wien, Austria
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
LKH Feldkirch
🇦🇹Feldkirch, Austria
Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin
🇦🇹Innsbruck, Austria
Lexington Cardiology
🇺🇸Columbia, South Carolina, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Providence Cardiology d/b/a South Caroline Heart Center
🇺🇸Columbia, South Carolina, United States
KH Hietzing,4. Medizinische Abteilung Mit Kardiologie
🇦🇹Wien, Austria
Hospital Professor Doutor Fernando Fonseca
🇵🇹Amadora, Portugal
Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
🇵🇹Carnaxide, Portugal
Erasmus MC : University Medical Center
🇳🇱Rotterdam, Netherlands
Centro Hospitalar de Vila Nova de Gaia
🇵🇹Vila Nova de Gaia, Portugal
Klinični center Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital Santa Maria
🇵🇹Lisboa, Portugal
Fondazione Cardiocentro Ticino
🇨🇭Lugano, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
🇨🇭Lausanne, Switzerland
Albertinen-Krankenhaus
🇩🇪Hamburg, Germany
Brookwood Medical Center CardioVascular Associates
🇺🇸Birmingham, Alabama, United States
Royal Perth Hospital
🇦🇺Perth, Australia
The University of Chicago Medicine Hospital
🇺🇸Chicago, Illinois, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
Policlinico Casilino
🇮🇹Roma, Italy
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Forsyth Hospital
🇺🇸Winston-Salem, North Carolina, United States