MORE-CRT MPP: MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing
Sponsor
Abbott Medical Devices (Industry)
Overall Status
Terminated
CT.gov ID
NCT02006069
Collaborator
(none)
5,850
206
2
89.9
28.4
0.3
Study Details
Study Description
Brief Summary
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.
Study Design
Study Type:
Interventional
Actual Enrollment
:
5850 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)
Study Start Date
:
Dec 1, 2013
Actual Primary Completion Date
:
May 30, 2021
Actual Study Completion Date
:
May 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MPP ON MPP ON: feature is enabled |
Device: MPP
All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.
The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").
|
| No Intervention: MPP OFF MPP OFF: feature not enabled |
Outcome Measures
Primary Outcome Measures
- CRT Response [Response to CRT after 6 months of MPP]
The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.
Secondary Outcome Measures
- Reduction of LVESV in acute phase [Baseline vs 6 Months]
Reduction of LVESV between baseline and 6 Months visit
- Clinical Composite Score evaluation [Baseline vs 12 Months]
Packer's Clinical Composite Score evaluation between baseline and 12 months and between 6 and 12 months
- Reverse LV remodeling [Baseline vs 12 Months]
Evaluation of Reverse LV remodeling, measured as changed in echo values LVESV, LVEDD and LVEF
- NYHA Class changes [Baseline vs 12 Months]
Evaluation of NYHA Class changes between Baseline and 12 Months FU
- 6MWT changes [Baseline vs 12 Months]
Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU
- Patient's QoL score changes (MLWHF, EQ-5D) [Baseline vs 12 Months]
Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) and EQ-5D Questionnaires
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
-
Must be willing and able to comply with study requirements
-
Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
Exclusion Criteria:
-
Already had a CRT device implanted
-
Myocardial Infarction, unstable angina within 40 days prior the enrollment
-
Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
-
Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
-
Primary valvular disease
-
Atrial Fibrillation:
-
Persistent AF at the time of enrollment
-
Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
-
History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
-
Unable to comply with the follow up schedule
-
Less than 18 years of age
-
Pregnant or are planning to become pregnant during the duration of the investigation
-
Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
-
Undergone a cardiac transplantation
-
Life expectancy < 12 months
-
Currently participating in any other clinical investigation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Center Research, LLC. | Huntsville | Alabama | United States | 35801 |
| 2 | Cardiovascular Associates of Mesa | Mesa | Arizona | United States | 85206 |
| 3 | Phoenix Cardiovascular Research Group | Phoenix | Arizona | United States | 85018 |
| 4 | Comprehensive Cardiovascular | Bakersfield | California | United States | 93309 |
| 5 | Glendale Adventist Medical Center | Glendale | California | United States | 91206 |
| 6 | Scripps Health | La Jolla | California | United States | 92037 |
| 7 | Eisenhower Medical Center | Rancho Mirage | California | United States | 92270 |
| 8 | Cardiac Rhythm Specialists, Inc. | Reseda | California | United States | 91335 |
| 9 | San Diego Cardiac Center | San Diego | California | United States | 92123 |
| 10 | Colorado Heart & Vascular, P.C. | Lakewood | Colorado | United States | 80228 |
| 11 | Sarasota Memorial Hospital | Sarasota | Florida | United States | 34239 |
| 12 | Coliseum Medical Centers | Macon | Georgia | United States | 31217 |
| 13 | Redmond Regional Medical Center | Rome | Georgia | United States | 30165 |
| 14 | St. Elizabeth Medical Center - South Unit | Edgewood | Kentucky | United States | 41017 |
| 15 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 16 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 17 | McLaren Health Care Corporation | Auburn Hills | Michigan | United States | 48326 |
| 18 | MidMichigan Medical Center-Midland | Midland | Michigan | United States | 48670 |
| 19 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 20 | CHI Health Creighton University Medical Center-Bergan Mercy | Omaha | Nebraska | United States | 68124 |
| 21 | Deborah Heart and Lung Center | Browns Mills | New Jersey | United States | 08015 |
| 22 | Cardiology Associates of Fairfield County, PC | Haddon Heights | New Jersey | United States | 08035 |
| 23 | Samaritan Heart & Vascular Institute - Cardiology Dept. | Corvallis | Oregon | United States | 97330 |
| 24 | Lancaster General Hospital | Lancaster | Pennsylvania | United States | 17602 |
| 25 | St. Francis Hospital | Greenville | South Carolina | United States | 29601 |
| 26 | Erlanger Medical Center | Chattanooga | Tennessee | United States | 37403 |
| 27 | Methodist University Hospital | Memphis | Tennessee | United States | 38104 |
| 28 | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | United States | 75390-9016 |
| 29 | Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas | United States | 76104 |
| 30 | Memorial Katy Cardiology Associates | Houston | Texas | United States | 77094 |
| 31 | Vivek Mangla, MD | Lufkin | Texas | United States | 75904 |
| 32 | EP Heart | The Woodlands | Texas | United States | 77384 |
| 33 | Royal Adelaide Hospital | Adelaide | Australia | ||
| 34 | Flinders Medical Centre | Bedford Park | Australia | 5042 | |
| 35 | St. Andrews War Memorial Hospital | Brisbane | Australia | ||
| 36 | The Alfred Hospital | Melbourne | Australia | ||
| 37 | Westmead Hospital | Westmead | Australia | ||
| 38 | Krankenhaus der Stadt St. Poelten | St. Poelten | Austria | ||
| 39 | Krankenhaus Hietzing | Vienna | Austria | 1130 | |
| 40 | Wilhelminenspital | Vienna | Austria | ||
| 41 | Hopital Erasme | Brussels | Belgium | ||
| 42 | St. Joseph Gilly | Gilly | Belgium | ||
| 43 | Foothills Medical Centre | Calgary | Canada | ||
| 44 | Royal Alexandra Hospital | Edmonton | Canada | ||
| 45 | QEII Health Sciences | Halifax | Canada | ||
| 46 | Kingston General Hospital | Kingston | Canada | ||
| 47 | Institut de Cardiologie de Montreal | Montreal | Canada | ||
| 48 | Hôtel Dieu de CHUM | Montréal | Canada | ||
| 49 | McGill University Health Centre General Hospital | Montréal | Canada | ||
| 50 | Institut de Cardiologie de Quebec | Sainte-Foy | Canada | ||
| 51 | CHUS Fleurimont | Sherbrooke | Canada | J1H 5N4 | |
| 52 | HSC, Eastern Health | St. Johns | Canada | ||
| 53 | Rouge Valley Centenary | Toronto | Canada | ||
| 54 | St. Paul's Hospital | Vancouver | Canada | ||
| 55 | Prince of Wales Hospital | Hong Kong | China | ||
| 56 | Angiografia Clinica de Occidente | Cali | Colombia | ||
| 57 | Clínica Cardio VID | Medellín | Colombia | ||
| 58 | Odense University Hospital | Odense | Fyn | Denmark | 5000 |
| 59 | Aalborg Sygehus Syd | Aalborg | Nordjylland | Denmark | DK-9000 |
| 60 | Skejby University Hospital | Aarhus | Denmark | ||
| 61 | Keski-Suomi Central Hospital | Jyvaskyla | Finland | ||
| 62 | Turku University Hospital | Turku | Finland | ||
| 63 | Hôpital Clairval | Marseille | Alpes | France | 13009 |
| 64 | CHU Cavale Blanche | Brest | France | ||
| 65 | CHU Trousseau | Chambray-lès-Tours | France | ||
| 66 | CHU François Mitterrand Dijon Bourgogne | Dijon | France | ||
| 67 | CHRU Albert Michallon | Grenoble | France | ||
| 68 | CHRU Lille | Lille | France | ||
| 69 | Hopital Saint Philibert | Lomme | France | ||
| 70 | Hôpital Saint Joseph | Marseille | France | ||
| 71 | Centre Hospitalier de Belfort-Montbeliard | Montbéliard | France | ||
| 72 | CHU Montpellier | Montpellier | France | ||
| 73 | CHU de Nancy - Hopital de Brabois | Nancy | France | ||
| 74 | CHU Hopital G. & R. Laënnec | Nantes | France | 44093 | |
| 75 | Nouvelles cliniques Nantaises | Nantes | France | ||
| 76 | Centre Cardiologique Du Nord | Paris | France | ||
| 77 | Hopital Pitiè Salpetrière | Paris | France | ||
| 78 | Institute Cardio. Paris-Sud - Institut Jacques Cartier | Paris | France | ||
| 79 | CHRU Hôpital de Pontchaillou | Rennes | France | 35033 | |
| 80 | CHRU Rouen Hospital Charles Nicolle | Rouen | France | ||
| 81 | CHR de La Reunion - Site du CHFG | Saint-Denis Cedex | France | 97405 | |
| 82 | Centre Hospitalier de Valence | Valence | France | ||
| 83 | Clinique du Tonkin | Villeurbanne | France | ||
| 84 | Hegau-Bodensee-Hochrhein-Kliniken GmbH | Singen | Baden-Wurttemberg | Germany | 78224 |
| 85 | Universitäts-Herzzentrum Freiburg - Bad Krozingen | Bad Krozingen | Baden-Württemberg | Germany | 79189 |
| 86 | Kerckhoff-Klinik gGmbH | Bad Nauheim | Hessen | Germany | 61231 |
| 87 | Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem | Göttingen | Niedersachsen | Germany | 37073 |
| 88 | Medizinische Hochschule Hannover | Hannover | Niedersachsen | Germany | 30625 |
| 89 | Medizinische Einrichtungen der Universität zu Köln | Köln | Nordrhein-Westfalen | Germany | 50931 |
| 90 | Evangelisches Krankenhaus Kalk gGmbH | Köln | Nordrhein-Westfalen | Germany | 51103 |
| 91 | Herz-und Diabetes Zentrum NRW | Bad Oeynhausen | Germany | ||
| 92 | Schuchtermann-Schillersche Kliniken | Bad Rothenfelde | Germany | ||
| 93 | Charite Campus Virchow Klinikum | Berlin | Germany | ||
| 94 | Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | Germany | ||
| 95 | Klinikum Bielefeld | Bielefeld | Germany | ||
| 96 | Berufsgenossenschaftliche Kliniken Bergmannsheil | Bochum | Germany | ||
| 97 | Klinikum Coburg | Coburg | Germany | ||
| 98 | Helios-Klinikum Erfurt GmbH | Erfurt | Germany | ||
| 99 | Kliniken der Friedrich-Alexander-Universität | Erlangen | Germany | ||
| 100 | Elisabeth-Krankenhaus Essen GmbH | Essen | Germany | ||
| 101 | Universitatsklinikum Greifswald | Greifswald | Germany | ||
| 102 | Universitätsmedizin Göttingen Georg-August-Universität | Göttingen | Germany | ||
| 103 | Klinikum Gütersloh gGmbH | Gütersloh | Germany | ||
| 104 | Albertinen-Krankenhaus Hamburg | Hamburg | Germany | 22457 | |
| 105 | Klinikum Ingolstadt | Ingolstadt | Germany | ||
| 106 | St. Vinzenz-Hospital | Köln | Germany | ||
| 107 | Klinikum St. Georg gGMbH | Leipzig | Germany | ||
| 108 | Universitatsklinikum Leipzig | Leipzig | Germany | ||
| 109 | Klinikum Ludenscheid | Ludenscheid | Germany | ||
| 110 | St.-Marien-Hospital GmbH | Lünen | Germany | ||
| 111 | Universitatsklinikum Muenster | Muenster | Germany | ||
| 112 | Deutsches Herzzentrum München des Freistaates Bayern | München | Germany | ||
| 113 | Klinikum Oldenburg | Oldenburg | Germany | ||
| 114 | Krankenhaus der Barmherzigen Bruder | Trier | Germany | ||
| 115 | Kliniken Villingen-Schwenningen | Villingen-Schwenningen | Germany | ||
| 116 | Universitätsklinikum Würzburg | Würzburg | Germany | ||
| 117 | The Onassis Cardiac Center | Athens | Greece | 17674 | |
| 118 | Medanta - The Medicity Hospital | Gurgaon | Haryana | India | 122 001 |
| 119 | Fortis Hospital | Bangalore | Karnataka | India | 560076 |
| 120 | Care Institute of Medical Sciences | Ahmedabad | India | ||
| 121 | Postgraduate Institute of Medical Education & Research | Chandigarh | India | ||
| 122 | Apollo Hospital | Chennai | India | ||
| 123 | CARE Banjara | Hyderabad | India | ||
| 124 | Medanta Medicity Hospital | New Delhi | India | 110017 | |
| 125 | Escorts Heart Institute and Research Centre | New Delhi | India | ||
| 126 | Rabin Medical Center | Petah Tikva | Israel | 49100 | |
| 127 | Sheba Medical Center | Ramat Gan | Israel | ||
| 128 | Tel Aviv Medical Center | Tel Aviv | Israel | 64239 | |
| 129 | Az.Osp.Universitaria Consorziale Policlinico | Bari | Italy | ||
| 130 | Azienda Ospedaliera Di Venere | Bari | Italy | ||
| 131 | Policlinico S.Orsola Malpighi | Bologna | Italy | ||
| 132 | Az. Osp. Spedali Civili di Brescia | Brescia | Italy | ||
| 133 | Azienda Ospedaliera S. Anna e S Sebastiano | Caserta | Italy | ||
| 134 | Presidio Osp. Vito Fazzi | Lecce | Italy | ||
| 135 | Clinica Mediterranea | Naples | Italy | ||
| 136 | Ospedale dei Pellegrini | Naples | Italy | ||
| 137 | Ospedale S. Giovanni Bosco | Naples | Italy | ||
| 138 | Az Osp.Universitaria Maggiore della Carità | Novara | Italy | ||
| 139 | Università degli Studi di Padova | Padova | Italy | 35128 | |
| 140 | Casa di Cura Dott. Pederzoli | Peschiera del Garda | Italy | ||
| 141 | Az. Osp. Universitaria Pisana-Presidio Santa Chiara | Pisa | Italy | ||
| 142 | Ospedale di Portogruaro | Portogruaro | Italy | ||
| 143 | Azienda Ospedaliera "Civile - Maria Paternò Arezzo" | Ragusa | Italy | ||
| 144 | Ospedale Madre G. Vannini | Roma | Italy | 00177 | |
| 145 | Policlinico Casilino | Roma | Italy | ||
| 146 | Ospedale S. Giovanni Calibita Fatebenefratelli di Roma | Rome | Italy | ||
| 147 | Azienda Ospedaliera S. Anna | San Fermo della Battaglia | Italy | 1 22020 | |
| 148 | Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | 71013 | |
| 149 | Ospedale Civile Maggiore di Verona Borgo Trento | Verona | Italy | ||
| 150 | Samsung Medical Center | Seoul | Gangnam-gu | Korea, Republic of | 135-710 |
| 151 | Seoul St. Mary's Hospital | Seoul | Seocho-gu | Korea, Republic of | 137-701 |
| 152 | Sejong General Hospital | Bucheon-si | Korea, Republic of | ||
| 153 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | ||
| 154 | Seoul National University Hospital | Seoul | Korea, Republic of | ||
| 155 | Yonsei University Health System | Seoul | Korea, Republic of | ||
| 156 | American University of Beirut Medical Center | Beirut | Lebanon | ||
| 157 | Institut Jantung Negara | Kuala Lumpur | Malaysia | 50400 | |
| 158 | Mater Dei Hospital | Paola | Malta | ||
| 159 | Twee Steden Ziekenhuis | Tilburg | Noord-Brabant | Netherlands | 5042 AD |
| 160 | Amsterdam Academic Medical Center (AMC) | Amsterdam | Netherlands | ||
| 161 | Catharina Ziekenhuis | Eindhoven | Netherlands | ||
| 162 | Medisch Spectrum Twente | Enschede | Netherlands | ||
| 163 | Isala Ziekenhuis | Zwolle | Netherlands | ||
| 164 | Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca | Katowice | Slaskie | Poland | 40-635 |
| 165 | Slaskie Centrum Chorob Serca | Zabrze | Slask | Poland | 41-800 |
| 166 | Szpital Kliniczny Premienienia Panskiego | Poznan | Wielkopolskie | Poland | 61-848 |
| 167 | Wojewodzki Specjalistyczny Szpital im. Bieganskiego | Lodz | Poland | ||
| 168 | Hospital de Braga | Braga | Portugal | ||
| 169 | Centro Hospitalar do Alto Ave, Unidade de Guimarães | Creixomil | Portugal | 4835-044 | |
| 170 | Hospital Garcia de Orta, EPE | Lisboa | Portugal | ||
| 171 | Hospital de Santa Cruz | Lisbon | Portugal | ||
| 172 | Santa Maria Hospital | Lisbon | Portugal | ||
| 173 | Centro Hospitalar Vila Nova Gaia | Vila Nova de Gaia | Portugal | 4434 502 | |
| 174 | Arrhythmia Group | Ponce | Puerto Rico | ||
| 175 | Heart Rhythm Management | San Juan | Puerto Rico | ||
| 176 | King Fahad Armed Forces Hospital | Jeddah | Saudi Arabia | 21159 | |
| 177 | King Fahad Medical City | Riyadh | Saudi Arabia | ||
| 178 | National University Hospital | Singapore | Singapore | ||
| 179 | Hospital Universitario A Coruña | A Coruña | Spain | ||
| 180 | Hospital Universitario Infanta Cristina | Badajoz | Spain | ||
| 181 | Hospital de la Santa Creu y Sant Pau | Barcelona | Spain | ||
| 182 | Hospital Universitario Virgen de la Nieves | Granada | Spain | ||
| 183 | Complexo Hospitalario Universitario de Santiago | Madrid | Spain | 15706 | |
| 184 | Fundación Jiménez Díaz | Madrid | Spain | 28040 | |
| 185 | Hospital General Universitario Gregorio Maranon | Madrid | Spain | ||
| 186 | Hospital Ramon y Cajal | Madrid | Spain | ||
| 187 | Hospital Universitario Doce de Octubre | Madrid | Spain | ||
| 188 | Hospital Universitario Puerta de Hierro | Madrid | Spain | ||
| 189 | HCU Virgen de la Victoria | Malaga | Spain | ||
| 190 | Hospital Universitari i Politecnic La Fe | Valencia | Spain | ||
| 191 | Hospital Alvaro Cunqueiro | Vigo | Spain | ||
| 192 | Hospital Universitario Miguel Servet | Zaragoza | Spain | ||
| 193 | Karolinska University Hospital Huddinge | Stockholm | Sweden | ||
| 194 | Hopital Cantonal Universitaire de Geneva | Geneva | Switzerland | ||
| 195 | National Taiwan University | Taipei City | Taipei | Taiwan | 10002 |
| 196 | Chang Gung Memorial Hospital | LinKou | Taiwan | 333 | |
| 197 | Wansbeck General Hospital | Ashington | United Kingdom | ||
| 198 | Queen Elizabeth Hospital | Birmingham | United Kingdom | B15 2TH | |
| 199 | The Royal Sussex Country Hospital | Brighton | United Kingdom | ||
| 200 | Golden Jubilee National Hospital | Glasgow | United Kingdom | ||
| 201 | Kings College Hospital | London | United Kingdom | ||
| 202 | St. Thomas Hospital | London | United Kingdom | ||
| 203 | Manchester Heart Center, Manchester Royal Infirmary | Manchester | United Kingdom | M13 9WL | |
| 204 | John Radcliffe Hospital | Oxford | United Kingdom | ||
| 205 | Southampton General Hospital | Southampton | United Kingdom | ||
| 206 | The Great Western Hospital | Swindon | United Kingdom |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Study Chair: Christophe Leclercq, Centre Cardio-Pneumologique, CHU Pontchaillou
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abbott Medical Devices
ClinicalTrials.gov Identifier:
NCT02006069
Other Study ID Numbers:
- CR-13-006-ID-HF
First Posted:
Dec 9, 2013
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Abbott Medical Devices
Additional relevant MeSH terms: