Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
NCT ID: NCT01534234
Last Updated: 2019-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1039 participants
INTERVENTIONAL
2012-01-31
2019-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SonR group
SonR CRT Optimization
PARADYM RF SONR
SonR CRT Optimization
ECHO group
Echocardiographic Optimization
PARADYM RF SONR
Echocardiography Optimization
Interventions
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PARADYM RF SONR
SonR CRT Optimization
PARADYM RF SONR
Echocardiography Optimization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Sorin CRM
UNKNOWN
MicroPort CRM
INDUSTRY
Responsible Party
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Principal Investigators
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Josep Brugada
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Brookwood Medical Center CardioVascular Associates
Birmingham, Alabama, United States
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
Lexington Cardiology
Columbia, South Carolina, United States
Providence Cardiology d/b/a South Caroline Heart Center
Columbia, South Carolina, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
VA North Texas Health Care System
Dallas, Texas, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
Princess Alexandra Hospital
Brisbane, , Australia
Royal Perth Hospital
Perth, , Australia
LKH Feldkirch
Feldkirch, , Austria
Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin
Innsbruck, , Austria
KH Hietzing,4. Medizinische Abteilung Mit Kardiologie
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
SMZ-Ost, 1 Medizinische Abteilung
Vienna, , Austria
Hôpital de la Cavale Blanche-CHU BREST
Brest, , France
CHU - Hopital Michallon
Grenoble, , France
CHRU de Lille,Hôpital Cardiologique
Lille, , France
Centre Hospitalier Universitaire de La Timone
Marseille, , France
Institut Jacques Cartier
Massy, , France
Nouvelles Cliniques Nantaises
Nantes, , France
InParys CLINIQUE BIZET
Paris, , France
CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque
Pessac, , France
CH Poitiers
Poitiers, , France
CHU Charles Nicolle
Rouen, , France
CHU - Hopital Nord
Saint-Etienne, , France
CH de Rangueil
Toulouse, , France
Chru Trousseau
Tours, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
La Clinique du Tonkin
Villeurbanne, , France
Herz- und Gefässzentrum Bad Bevensen
Bad Bevensen, , Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
St.-Marien-Hospital
Bonn, , Germany
Universitätskliniken Bonn
Bonn, , Germany
Klinikum Coburg
Coburg, , Germany
Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
Frankfurt, , Germany
Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau, , Germany
Albertinen-Krankenhaus
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Schleswig-HolsteinCampus Kiel
Kiel, , Germany
Klinikum Ludwigshafen
Ludwigshafen, , Germany
Klinikum Magdeburg gemeinnützige GmbH
Magdeburg, , Germany
Klinikum Grosshadern
München, , Germany
Universitätsklinik Münster Innere Medizin C
Münster, , Germany
Krankenhaus Reinbek St. Adolf-Stift
Reinbek, , Germany
Ospedale Civile Ss. Antonio E Biago
Alessandria, , Italy
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
Ospedale Maurizio Bufalini
Cesena, , Italy
Azienda Ospedaliera S. Croce E Carle
Cuneo, , Italy
Azienda Osped-Universitaria CAREGGI
Florence, , Italy
Casa Di Cura Montevergine
Mercogliano, , Italy
Osp. Niguarda
Milan, , Italy
Ospedale Civile
Mirano, , Italy
SUN Ospedale Monaldi
Napoli, , Italy
Fondazione Toscana Gabriele Monasterio
Pisa, , Italy
Policlinico Casilino
Roma, , Italy
Osp. S. Maria della Misericordia
Rovigo, , Italy
IRCCS Multimedica
Sesto San Giovanni, , 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
Slingeland Ziekenhuis
Doetinchem, , Netherlands
Erasmus MC : University Medical Center
Rotterdam, , Netherlands
Vlietland Ziekenhuis
Schiedam, , Netherlands
Sint Elisabeth Ziekenhuis
Tilburg, , Netherlands
Ziekenhuis Bernhoven
Veghel, , Netherlands
ISALA Klinieken
Zwolle, , Netherlands
Hospital Professor Doutor Fernando Fonseca
Amadora, , Portugal
Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
Carnaxide, , Portugal
Hospital Santa Maria
Lisbon, , Portugal
Centro Hospitalar do Porto CHP Hospital de Santo Antonio
Porto, , Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, , Portugal
Klinični center Ljubljana
Ljubljana, , Slovenia
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
Hospital Donostia
Donostia / San Sebastian, , Spain
H. Virgen de las Nieves
Granada, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Puerta de Hierro
Majadahonda, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
H. Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Marques de Valdecilla Sur
Santander, , Spain
Hospital Virgen de Valme
Seville, , Spain
H. General Universit.
Valencia, , Spain
CHU VIGO
Vigo, , Spain
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
Lausanne, , Switzerland
Fondazione Cardiocentro Ticino
Lugano, , Switzerland
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
Leeds General Infirmary
Leeds, , United Kingdom
Genfield General Hospital
Leicester, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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Brugada J, Delnoy PP, Brachmann J, Reynolds D, Padeletti L, Noelker G, Kantipudi C, Rubin Lopez JM, Dichtl W, Borri-Brunetto A, Verhees L, Ritter P, Singh JP; RESPOND CRT Investigators. Contractility sensor-guided optimization of cardiac resynchronization therapy: results from the RESPOND-CRT trial. Eur Heart J. 2017 Mar 7;38(10):730-738. doi: 10.1093/eurheartj/ehw526.
Brugada J, Brachmann J, Delnoy PP, Padeletti L, Reynolds D, Ritter P, Borri-Brunetto A, Singh JP. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the clinical trial of the SonRtip lead and automatic AV-VV optimization algorithm in the paradym RF SonR CRT-D (RESPOND CRT) trial. Am Heart J. 2014 Apr;167(4):429-36. doi: 10.1016/j.ahj.2013.12.007. Epub 2013 Dec 19.
Other Identifiers
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ITSY06 - RESPOND CRT
Identifier Type: -
Identifier Source: org_study_id
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