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

Primary Purpose

Heart Failure NYHA Class III and Ambulatory IV

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PARADYM RF SONR
PARADYM RF SONR
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class III and Ambulatory IV focused on measuring CRT-D device, Severe HF (NYHA Class III or ambulatory IV), stable, optimal drug regimen, sinus rhythm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brookwood Medical Center CardioVascular Associates
  • AZ Heart Rhythm Center
  • Brotman Medical Center
  • Hoag Hospital
  • Scripps Mercy Hospital
  • Broward General Medical Center
  • St. Vincent's HealthCare
  • Piedmont Hospital Research Institute
  • Rush University Medical Center
  • Swedish Covenant Hospital
  • The University of Chicago Medicine Hospital
  • Ochsner Clinic Foundation
  • Massachusetts General Hospital-CAS
  • Sparrow Clinical Research Institute
  • Rutgers New Jersey Medical School
  • St. Luke's Roosevelt Hospital Center
  • New York Presbyterian
  • Rochester General Hospital
  • Forsyth Hospital
  • Good Samaritan Hospital
  • University Hospitals of Cleveland
  • Cleveland Clinic
  • St. Francis Hospital
  • Drexel University College of Medicine
  • Hospital of the University of PA
  • Lexington Cardiology
  • Providence Cardiology d/b/a South Caroline Heart Center
  • McLeod Regional Medical Center
  • VA North Texas Health Care System
  • Baylor Heart & Vascular Hospital
  • Plaza Medical Center of Fort Worth
  • Princess Alexandra Hospital
  • Royal Perth Hospital
  • LKH Feldkirch
  • Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin
  • KH Hietzing,4. Medizinische Abteilung Mit Kardiologie
  • Wilhelminenspital
  • SMZ-Ost, 1 Medizinische Abteilung
  • Hôpital de la Cavale Blanche-CHU BREST
  • CHU - Hopital Michallon
  • CHRU de Lille,Hôpital Cardiologique
  • Centre Hospitalier Universitaire de La Timone
  • Institut Jacques Cartier
  • Nouvelles Cliniques Nantaises
  • InParys CLINIQUE BIZET
  • CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque
  • CH Poitiers
  • CHU Charles Nicolle
  • CHU - Hopital Nord
  • CH de Rangueil
  • Chru Trousseau
  • CHU Brabois
  • La Clinique du Tonkin
  • Herz- und Gefässzentrum Bad Bevensen
  • Kerckhoff-Klinik GmbH
  • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Deutsches Herzzentrum Berlin
  • St.-Marien-Hospital
  • Universitätskliniken Bonn
  • Klinikum Coburg
  • Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
  • Universitäts-Herzzentrum Freiburg
  • Albertinen-Krankenhaus
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Schleswig-HolsteinCampus Kiel
  • Klinikum Ludwigshafen
  • Klinikum Magdeburg gemeinnützige GmbH
  • Klinikum Grosshadern
  • Universitätsklinik Münster Innere Medizin C
  • Krankenhaus Reinbek St. Adolf-Stift
  • Ospedale Civile Ss. Antonio E Biago
  • Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
  • Azienda Ospedaliera S. Anna e S. Sebastiano
  • AOU Ferrarotti-Alessi
  • Ospedale Maurizio Bufalini
  • Azienda Ospedaliera S. Croce E Carle
  • Azienda Osped-Universitaria CAREGGI
  • Casa Di Cura Montevergine
  • Osp. Niguarda
  • Ospedale Civile
  • SUN Ospedale Monaldi
  • Fondazione Toscana Gabriele Monasterio
  • Policlinico Casilino
  • Osp. S. Maria della Misericordia
  • IRCCS Multimedica
  • A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U
  • A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera
  • Ospedale Cà Foncello
  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste
  • Az. Osp. Univ. S. Maria della Misericordia
  • Slingeland Ziekenhuis
  • Erasmus MC : University Medical Center
  • Vlietland Ziekenhuis
  • Sint Elisabeth Ziekenhuis
  • Ziekenhuis Bernhoven
  • ISALA Klinieken
  • Hospital Professor Doutor Fernando Fonseca
  • Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
  • Hospital Santa Maria
  • Centro Hospitalar do Porto CHP Hospital de Santo Antonio
  • Centro Hospitalar de Vila Nova de Gaia
  • Klinični center Ljubljana
  • Hospital General Universitario de Alicante
  • Hospital Germans Trias i Pujol
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Clinico de Barcelona
  • H. Virgen de las Nieves
  • Hospital Universitario La Paz
  • Hospital Puerta de Hierro
  • Hospital Universitario Virgen de la Victoria
  • H. Universitario Central de Asturias
  • Hospital Donostia
  • Hospital Universitario Marques de Valdecilla Sur
  • Hospital Virgen de Valme
  • H. General Universit.
  • CHU VIGO
  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
  • Fondazione Cardiocentro Ticino
  • Queen Elizabeth Hospital
  • Papworth Everard
  • Ashford and St. Peter's Hospitals NHS Trust
  • Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T
  • Leeds General Infirmary
  • Genfield General Hospital
  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SonR group

ECHO group

Arm Description

SonR CRT Optimization

Echocardiographic Optimization

Outcomes

Primary Outcome Measures

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%.
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)
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)
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

Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 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
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
For all patients implanted with the SonRtip lead.
SonR tip lead sensing threshold
For all patients implanted with the SonRtip lead.
SonR tip lead pacing impedance
For all patients implanted with the SonRtip lead.
Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause
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
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)
Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL)
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
Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class)
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 CRT effectiveness: Report echocardiographic parameters trend at M12
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
Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group
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)
The amount of time (mean, median, standard deviation, minimum, maximum)in each group will be evaluated in all patients implanted
Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO)
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 Adverse Events for both group to assess CRT effectiveness / System Safety
For all patients enrolled all Adverse Events will be reported.

Full Information

First Posted
September 27, 2011
Last Updated
January 9, 2019
Sponsor
MicroPort CRM
Collaborators
Sorin CRM
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1. Study Identification

Unique Protocol Identification Number
NCT01534234
Brief Title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Acronym
RESPOND-CRT
Official Title
Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM
Collaborators
Sorin CRM

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class III and Ambulatory IV
Keywords
CRT-D device, Severe HF (NYHA Class III or ambulatory IV), stable, optimal drug regimen, sinus rhythm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1039 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SonR group
Arm Type
Experimental
Arm Description
SonR CRT Optimization
Arm Title
ECHO group
Arm Type
Active Comparator
Arm Description
Echocardiographic Optimization
Intervention Type
Device
Intervention Name(s)
PARADYM RF SONR
Other Intervention Name(s)
Automatic Hemodynamic CRT Optimization
Intervention Description
SonR CRT Optimization
Intervention Type
Device
Intervention Name(s)
PARADYM RF SONR
Other Intervention Name(s)
Echo Optimization
Intervention Description
Echocardiography Optimization
Primary Outcome Measure Information:
Title
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%.
Description
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.
Time Frame
12 months
Title
Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months)
Description
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.
Time Frame
3 months
Title
Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of CRT effectiveness and CRT Safety: evaluation of Mortality and HF hospitalizations at 12 months
Description
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
Time Frame
12 months
Title
Evaluation of CRT effectiveness and CRT therapy: Proportion of patients worsened at 12 months
Description
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
Time Frame
12 months
Title
SonR tip lead pacing threshold
Description
For all patients implanted with the SonRtip lead.
Time Frame
24 months
Title
SonR tip lead sensing threshold
Description
For all patients implanted with the SonRtip lead.
Time Frame
24 months
Title
SonR tip lead pacing impedance
Description
For all patients implanted with the SonRtip lead.
Time Frame
24 months
Title
Evaluation of CRT effectiveness and CRT and System Safety: Report deaths for any cause
Description
The report of the deaths occurred consists of the percentage of dead patients, the causes of death, the time to death, the survival curves.
Time Frame
24 months
Title
Report Heart Failure-related events to assess CRT effectiveness
Description
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)
Time Frame
24 months
Title
Report Quality of life (QOL) improvement to assess CRT effectiveness (percentage of patients with improvements in QOL)
Description
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
Time Frame
24 months
Title
Report NYHA class improvement to assess CRT effectiveness (the percentage of patients with improved in NYHA class)
Description
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
Time Frame
24 months
Title
Evaluation of CRT effectiveness: Report echocardiographic parameters trend at M12
Description
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
Time Frame
12 months
Title
Evaluation of SonR CRT Optimization Effectiveness - Superiority by assessment the proportion of responder patients in SonR group
Description
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).
Time Frame
18/24 months
Title
Evaluation of the time spent for CRT optimization by the physician on optimization in each group (sonR and ECHO)
Description
The amount of time (mean, median, standard deviation, minimum, maximum)in each group will be evaluated in all patients implanted
Time Frame
24 months
Title
Evaluation of the Number of re-optimizations performed in both groups (SonR and ECHO)
Description
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).
Time Frame
24 months
Title
Report Adverse Events for both group to assess CRT effectiveness / System Safety
Description
For all patients enrolled all Adverse Events will be reported.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep Brugada
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brookwood Medical Center CardioVascular Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
AZ Heart Rhythm Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Brotman Medical Center
City
Culver City
State/Province
California
ZIP/Postal Code
90232
Country
United States
Facility Name
Hoag Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Scripps Mercy Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92942
Country
United States
Facility Name
Broward General Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
St. Vincent's HealthCare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Piedmont Hospital Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Swedish Covenant Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
The University of Chicago Medicine Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Massachusetts General Hospital-CAS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
New York Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
Forsyth Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Hospital of the University of PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Lexington Cardiology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Providence Cardiology d/b/a South Caroline Heart Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Baylor Heart & Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Plaza Medical Center of Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Princess Alexandra Hospital
City
Brisbane
ZIP/Postal Code
4104
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
LKH Feldkirch
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
KH Hietzing,4. Medizinische Abteilung Mit Kardiologie
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Wilhelminenspital
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
SMZ-Ost, 1 Medizinische Abteilung
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
Hôpital de la Cavale Blanche-CHU BREST
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU - Hopital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU de Lille,Hôpital Cardiologique
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire de La Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Institut Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes
ZIP/Postal Code
44277
Country
France
Facility Name
InParys CLINIQUE BIZET
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CH Poitiers
City
Poitiers
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
Country
France
Facility Name
CHU - Hopital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CH de Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Chru Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHU Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
La Clinique du Tonkin
City
Villeurbanne
ZIP/Postal Code
69626
Country
France
Facility Name
Herz- und Gefässzentrum Bad Bevensen
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
St.-Marien-Hospital
City
Bonn
ZIP/Postal Code
53115
Country
Germany
Facility Name
Universitätskliniken Bonn
City
Bonn
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Kardiocentrum Frankfurt and der Klinik Rotes Kreuz
City
Frankfurt
ZIP/Postal Code
60316
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Albertinen-Krankenhaus
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-HolsteinCampus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Klinikum Magdeburg gemeinnützige GmbH
City
Magdeburg
ZIP/Postal Code
39130
Country
Germany
Facility Name
Klinikum Grosshadern
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitätsklinik Münster Innere Medizin C
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Krankenhaus Reinbek St. Adolf-Stift
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
Facility Name
Ospedale Civile Ss. Antonio E Biago
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Facility Name
Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliera S. Anna e S. Sebastiano
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Facility Name
AOU Ferrarotti-Alessi
City
Catania
ZIP/Postal Code
94124
Country
Italy
Facility Name
Ospedale Maurizio Bufalini
City
Cesena
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce E Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Azienda Osped-Universitaria CAREGGI
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Casa Di Cura Montevergine
City
Mercogliano
ZIP/Postal Code
83040
Country
Italy
Facility Name
Osp. Niguarda
City
Milan
Country
Italy
Facility Name
Ospedale Civile
City
Mirano
ZIP/Postal Code
30035
Country
Italy
Facility Name
SUN Ospedale Monaldi
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Casilino
City
Roma
ZIP/Postal Code
00169
Country
Italy
Facility Name
Osp. S. Maria della Misericordia
City
Rovigo
ZIP/Postal Code
45100
Country
Italy
Facility Name
IRCCS Multimedica
City
Sesto San Giovanni
ZIP/Postal Code
20099
Country
Italy
Facility Name
A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Cà Foncello
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste
City
Trieste
ZIP/Postal Code
34142
Country
Italy
Facility Name
Az. Osp. Univ. S. Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Slingeland Ziekenhuis
City
Doetinchem
ZIP/Postal Code
7000
Country
Netherlands
Facility Name
Erasmus MC : University Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Vlietland Ziekenhuis
City
Schiedam
ZIP/Postal Code
3118 JH
Country
Netherlands
Facility Name
Sint Elisabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5000 LC
Country
Netherlands
Facility Name
Ziekenhuis Bernhoven
City
Veghel
ZIP/Postal Code
5461 AA
Country
Netherlands
Facility Name
ISALA Klinieken
City
Zwolle
ZIP/Postal Code
8000
Country
Netherlands
Facility Name
Hospital Professor Doutor Fernando Fonseca
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)
City
Carnaxide
ZIP/Postal Code
2799
Country
Portugal
Facility Name
Hospital Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Centro Hospitalar do Porto CHP Hospital de Santo Antonio
City
Porto
Country
Portugal
Facility Name
Centro Hospitalar de Vila Nova de Gaia
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Klinični center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinico de Barcelona
City
Barcelona
Country
Spain
Facility Name
H. Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
H. Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla Sur
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
H. General Universit.
City
Valencia
Country
Spain
Facility Name
CHU VIGO
City
Vigo
ZIP/Postal Code
3204
Country
Spain
Facility Name
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Fondazione Cardiocentro Ticino
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Queen Elizabeth Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Papworth Everard
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Ashford and St. Peter's Hospitals NHS Trust
City
Chertsey
Country
United Kingdom
Facility Name
Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
Genfield General Hospital
City
Leicester
ZIP/Postal Code
LE39QP
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27941020
Citation
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.
Results Reference
derived
PubMed Identifier
24655689
Citation
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.
Results Reference
derived

Learn more about this trial

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

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