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Heart Failure NYHA Class III and Ambulatory IVPhase 3RESPOND-CRTNCT01534234

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

A Phase 3 study testing PARADYM RF SONR in people with Heart Failure NYHA Class III and Ambulatory IV, run by MicroPort CRM at 125 sites in 12 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PARADYM RF SONR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,039 participants
Where
125 sitesin 12 countries
Study dates
Jan 2012to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 19Show fewer
  • 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

Trial locations and contacts

125 sites in 12 countries.

125 sites in 12 countries

United States31 sites

  • Piedmont Hospital Research Institute

    Atlanta, Georgia, 30303

  • Brookwood Medical Center CardioVascular Associates

    Birmingham, Alabama, 35243

  • Massachusetts General Hospital-CAS

    Boston, Massachusetts, 02114

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Swedish Covenant Hospital

    Chicago, Illinois, 60625

  • The University of Chicago Medicine Hospital

    Chicago, Illinois, 60637

  • Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Lexington Cardiology

    Columbia, South Carolina, 29204

  • Providence Cardiology d/b/a South Caroline Heart Center

    Columbia, South Carolina, 29204

  • Brotman Medical Center

    Culver City, California, 90232

  • VA North Texas Health Care System

    Dallas, Texas, 75216

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • St. Vincent's HealthCare

    Jacksonville, Florida, 32204

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48910

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • St. Luke's Roosevelt Hospital Center

    New York, New York, 10025

  • New York Presbyterian

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Hoag Hospital

    Newport Beach, California, 92663

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Hospital of the University of PA

    Philadelphia, Pennsylvania, 19104

  • AZ Heart Rhythm Center

    Phoenix, Arizona, 85016

  • Rochester General Hospital

    Rochester, New York, 14625

  • Scripps Mercy Hospital

    San Diego, California, 92942

  • St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Forsyth Hospital

    Winston-Salem, North Carolina, 27103

Other trials in United States

Italy20 sites

  • Ospedale Civile Ss. Antonio E Biago

    Alessandria, 15100

  • Az. Osp-Univ. Ospedali Riuniti Umberto I-Lancisi-Salesi

    Ancona, 60126

  • Azienda Ospedaliera S. Anna e S. Sebastiano

    Caserta, 81100

  • AOU Ferrarotti-Alessi

    Catania, 94124

  • Ospedale Maurizio Bufalini

    Cesena

  • Azienda Ospedaliera S. Croce E Carle

    Cuneo, 12100

  • Azienda Osped-Universitaria CAREGGI

    Florence, 50134

  • Casa Di Cura Montevergine

    Mercogliano, 83040

  • Osp. Niguarda

    Milan

  • Ospedale Civile

    Mirano, 30035

  • SUN Ospedale Monaldi

    Naples, 80131

  • Fondazione Toscana Gabriele Monasterio

    Pisa, 56126

  • Policlinico Casilino

    Roma, 00169

  • Osp. S. Maria della Misericordia

    Rovigo, 45100

  • IRCCS Multimedica

    Sesto San Giovanni, 20099

  • A.O. Città della Salute e della Scienza di Torino Cardiologia 1 - U

    Torino, 10126

  • A.O. Città della Salute e della Scienza di Torino Cardiologia 2 ospedaliera

    Torino, 10126

  • Ospedale Cà Foncello

    Treviso, 31100

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Trieste

    Trieste, 34142

  • Az. Osp. Univ. S. Maria della Misericordia

    Udine, 33100

Other trials in Italy

Germany17 sites

  • Herz- und Gefässzentrum Bad Bevensen

    Bad Bevensen, 29549

  • Kerckhoff-Klinik GmbH

    Bad Nauheim, 61231

  • Herz- und Diabeteszentrum Nordrhein-Westfalen

    Bad Oeynhausen, 32545

  • Deutsches Herzzentrum Berlin

    Berlin, 13353

  • St.-Marien-Hospital

    Bonn, 53115

  • Universitätskliniken Bonn

    Bonn

  • Klinikum Coburg

    Coburg, 96450

  • Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

    Frankfurt, 60316

  • Universitäts-Herzzentrum Freiburg

    Freiburg im Breisgau, 79106

  • Albertinen-Krankenhaus

    Hamburg, 22457

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Schleswig-HolsteinCampus Kiel

    Kiel, 24105

  • Klinikum Ludwigshafen

    Ludwigshafen, 67063

  • Klinikum Magdeburg gemeinnützige GmbH

    Magdeburg, 39130

  • Klinikum Grosshadern

    München, 81377

  • Universitätsklinik Münster Innere Medizin C

    Münster, 48149

  • Krankenhaus Reinbek St. Adolf-Stift

    Reinbek, 21465

Other trials in Germany

France15 sites

  • Hôpital de la Cavale Blanche-CHU BREST

    Brest, 29609

  • CHU - Hopital Michallon

    Grenoble, 38043

  • CHRU de Lille,Hôpital Cardiologique

    Lille, 59037

  • Centre Hospitalier Universitaire de La Timone

    Marseille, 13000

  • Institut Jacques Cartier

    Massy, 91300

  • Nouvelles Cliniques Nantaises

    Nantes, 44277

  • InParys CLINIQUE BIZET

    Paris, 75016

  • CHU de Bordeaux, Groupe hospitalier Sud, Hôpital Haut-L'évêque

    Pessac, 33604

  • CH Poitiers

    Poitiers

  • CHU Charles Nicolle

    Rouen

  • CHU - Hopital Nord

    Saint-Etienne, 42055

  • CH de Rangueil

    Toulouse, 31059

  • Chru Trousseau

    Tours, 37044

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54500

  • La Clinique du Tonkin

    Villeurbanne, 69626

Other trials in France

Spain14 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Clinico de Barcelona

    Barcelona

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • H. Virgen de las Nieves

    Granada

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Puerta de Hierro

    Majadahonda, 28222

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • H. Universitario Central de Asturias

    Oviedo, 33006

  • Hospital Universitario Marques de Valdecilla Sur

    Santander, 39008

  • Hospital Virgen de Valme

    Seville, 41014

  • H. General Universit.

    Valencia

  • CHU VIGO

    Vigo, 3204

Other trials in Spain

United Kingdom7 sites

  • Queen Elizabeth Hospital

    Birmingham

  • Papworth Everard

    Cambridge, CB23 3RE

  • Ashford and St. Peter's Hospitals NHS Trust

    Chertsey

  • Castle Hill Hospital Hull and East Yorkshire Hospitals NHS T

    Cottingham, HU16 5JQ

  • Leeds General Infirmary

    Leeds

  • Genfield General Hospital

    Leicester, LE39QP

  • King's College Hospital NHS Foundation Trust

    London

Other trials in United Kingdom

Netherlands6 sites

  • Slingeland Ziekenhuis

    Doetinchem, 7000

  • Erasmus MC : University Medical Center

    Rotterdam, 3015 CE

  • Vlietland Ziekenhuis

    Schiedam, 3118 JH

  • Sint Elisabeth Ziekenhuis

    Tilburg, 5000 LC

  • Ziekenhuis Bernhoven

    Veghel, 5461 AA

  • ISALA Klinieken

    Zwolle, 8000

Other trials in Netherlands

Austria5 sites

  • LKH Feldkirch

    Feldkirch, 6807

  • Lkh Innsbruck - Invasoren Kardiologie - Innere Medizin

    Innsbruck, 6020

  • KH Hietzing,4. Medizinische Abteilung Mit Kardiologie

    Vienna, 1130

  • Wilhelminenspital

    Vienna, 1160

  • SMZ-Ost, 1 Medizinische Abteilung

    Vienna, 1220

Other trials in Austria

Portugal5 sites

  • Hospital Professor Doutor Fernando Fonseca

    Amadora, 2720-276

  • Centro Hospitalar Lisboa Ocidental -Hospital de Santa Cruz (CHLO)

    Carnaxide, 2799

  • Hospital Santa Maria

    Lisbon

  • Centro Hospitalar do Porto CHP Hospital de Santo Antonio

    Porto

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Australia2 sites

  • Princess Alexandra Hospital

    Brisbane, 4104

  • Royal Perth Hospital

    Perth, 6000

Other trials in Australia

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

    Lausanne, 1011

  • Fondazione Cardiocentro Ticino

    Lugano, 6900

Other trials in Switzerland

Slovenia1 site

  • Klinični center Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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.

Read the 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.

Being tested
PARADYM RF SONR
Keywords
CRT-D device, Severe HF (NYHA Class III or ambulatory IV), stable, optimal drug regimen, sinus rhythm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PARADYM RF SONRDevice

    Also called Automatic Hemodynamic CRT Optimization

    SonR CRT Optimization

  • PARADYM RF SONRDevice

    Also called Echo Optimization

    Echocardiography Optimization

Study groups in NCT01534234
Study groupRoleWhat they receive
SonR groupExperimentalSonR CRT Optimization
Receives: Device: PARADYM RF SONR
ECHO groupActive comparatorEchocardiographic Optimization
Receives: Device: PARADYM RF SONR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 3 months

  3. 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.

    Measured: 12 months

Secondary outcomes (14)

  1. 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

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. SonR tip lead pacing threshold

    For all patients implanted with the SonRtip lead.

    Measured: 24 months

  4. SonR tip lead sensing threshold

    For all patients implanted with the SonRtip lead.

    Measured: 24 months

  5. SonR tip lead pacing impedance

    For all patients implanted with the SonRtip lead.

    Measured: 24 months

  6. 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.

    Measured: 24 months

  7. 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)

    Measured: 24 months

  8. 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

    Measured: 24 months

  9. 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

    Measured: 24 months

  10. 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

    Measured: 12 months

  11. 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).

    Measured: 18/24 months

  12. 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

    Measured: 24 months

  13. 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).

    Measured: 24 months

  14. Report Adverse Events for both group to assess CRT effectiveness / System Safety

    For all patients enrolled all Adverse Events will be reported.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionDec 2015
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,039 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01534234
Sponsor's protocol ID
ITSY06 - RESPOND CRT
Acronym
RESPOND-CRT
Status last verified
Jan 2019
First submitted
27 Sep 2011
Last updated
11 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated device
Yes
Expanded access
Available

Publications

  • 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.

    PubMed 27941020

  • 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.

    PubMed 24655689

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PARADYM RF SONR in people with Heart Failure NYHA Class III and Ambulatory IV, run by MicroPort CRM at 125 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Italy, Germany, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01534234, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.

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