MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

Not Applicable

Terminated

Conditions: Heart Failure

Interventions: Device: MPP

Registration Number: NCT02006069

Lead Sponsor: Abbott Medical Devices

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5850

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPP ON	MPP	MPP ON: feature is enabled

Primary Outcome Measures

Name	Time	Method
Percentage of Non-responder Patients Who Converted to Responders	Non-responder to responder conversion rate between randomization at 6 months and 12 months	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

Name	Time	Method
Reduction of Left Ventricular End-systolic Volume (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 as defined below, * Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation * Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation * Unchanged: the patient was neither improved nor worsened
Reverse Left Ventricular (LV) Remodeling	Baseline vs 12 Months	Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months
NYHA Class Changes	Baseline vs 12 Months	Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.
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)	Baseline vs 12 Months	Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).

Trial Locations

Locations (206): Cardiology Associates of Fairfield County, PC
🇺🇸
Haddon Heights, New Jersey, United States
Erlanger Medical Center
🇺🇸
Chattanooga, Tennessee, United States
Turku University Hospital
🇫🇮
Turku, Finland
Heart Rhythm Management
🇵🇷
San Juan, Puerto Rico
National University Hospital
🇸🇬
Singapore, Singapore
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Memorial Katy Cardiology Associates
🇺🇸
Houston, Texas, United States
Skejby University Hospital
🇩🇰
Aarhus, Denmark
Ospedale Civile Maggiore di Verona Borgo Trento
🇮🇹
Verona, Italy
Cardiovascular Associates of Mesa
🇺🇸
Mesa, Arizona, United States
Baptist Health Lexington
🇺🇸
Lexington, Kentucky, United States
Munson Medical Center
🇺🇸
Traverse City, Michigan, United States
St. Elizabeth Medical Center - South Unit
🇺🇸
Edgewood, Kentucky, United States
Institut de Cardiologie de Montreal
🇨🇦
Montreal, Canada
Baylor All Saints Medical Center at Fort Worth
🇺🇸
Fort Worth, Texas, United States
Royal Adelaide Hospital
🇦🇺
Adelaide, Australia
Deborah Heart and Lung Center
🇺🇸
Browns Mills, New Jersey, United States
McLaren Health Care Corporation
🇺🇸
Auburn Hills, Michigan, United States
CHI Health Creighton University Medical Center-Bergan Mercy
🇺🇸
Omaha, Nebraska, United States
Sarasota Memorial Hospital
🇺🇸
Sarasota, Florida, United States
EP Heart
🇺🇸
The Woodlands, Texas, United States
St. Andrews War Memorial Hospital
🇦🇺
Brisbane, Australia
Colorado Heart & Vascular, P.C.
🇺🇸
Lakewood, Colorado, United States
Redmond Regional Medical Center
🇺🇸
Rome, Georgia, United States
MidMichigan Medical Center-Midland
🇺🇸
Midland, Michigan, United States
Flinders Medical Centre
🇦🇺
Bedford Park, Australia
Coliseum Medical Centers
🇺🇸
Macon, Georgia, United States
St. Francis Hospital
🇺🇸
Greenville, South Carolina, United States
The Alfred Hospital
🇦🇺
Melbourne, Australia
Samaritan Heart & Vascular Institute - Cardiology Dept.
🇺🇸
Corvallis, Oregon, United States
Methodist University Hospital
🇺🇸
Memphis, Tennessee, United States
Vivek Mangla, MD
🇺🇸
Lufkin, Texas, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸
Dallas, Texas, United States
Westmead Hospital
🇦🇺
Westmead, Australia
Hopital Erasme
🇧🇪
Brussels, Belgium
Foothills Medical Centre
🇨🇦
Calgary, Canada
St. Joseph Gilly
🇧🇪
Gilly, Belgium
QEII Health Sciences
🇨🇦
Halifax, Canada
Kingston General Hospital
🇨🇦
Kingston, Canada
Royal Alexandra Hospital
🇨🇦
Edmonton, Canada
Hôtel Dieu de CHUM
🇨🇦
Montréal, Canada
Odense University Hospital
🇩🇰
Odense, Fyn, Denmark
Hôpital Clairval
🇫🇷
Marseille, Alpes, France
HSC, Eastern Health
🇨🇦
St. Johns, Canada
CHUS Fleurimont
🇨🇦
Sherbrooke, Canada
Aalborg Sygehus Syd
🇩🇰
Aalborg, Nordjylland, Denmark
CHR de La Reunion - Site du CHFG
🇫🇷
Saint-Denis Cedex, France
Klinikum Bielefeld
🇩🇪
Bielefeld, Germany
Universitatsklinikum Greifswald
🇩🇪
Greifswald, Germany
Charite Campus Virchow Klinikum
🇩🇪
Berlin, Germany
Centre Hospitalier de Belfort-Montbeliard
🇫🇷
Montbéliard, France
Hôpital Saint Joseph
🇫🇷
Marseille, France
CHU Hopital G. & R. Laënnec
🇫🇷
Nantes, France
Kerckhoff-Klinik gGmbH
🇩🇪
Bad Nauheim, Hessen, Germany
Hegau-Bodensee-Hochrhein-Kliniken GmbH
🇩🇪
Singen, Baden-Wurttemberg, Germany
Rabin Medical Center
🇮🇱
Petah Tikva, Israel
Klinikum Coburg
🇩🇪
Coburg, Germany
St. Vinzenz-Hospital
🇩🇪
Köln, Germany
Medanta - The Medicity Hospital
🇮🇳
Gurgaon, Haryana, India
Escorts Heart Institute and Research Centre
🇮🇳
New Delhi, India
Azienda Ospedaliera S. Anna e S Sebastiano
🇮🇹
Caserta, Italy
Clinica Mediterranea
🇮🇹
Naples, Italy
Ospedale dei Pellegrini
🇮🇹
Naples, Italy
Az. Osp. Universitaria Pisana-Presidio Santa Chiara
🇮🇹
Pisa, Italy
Helios-Klinikum Erfurt GmbH
🇩🇪
Erfurt, Germany
Schuchtermann-Schillersche Kliniken
🇩🇪
Bad Rothenfelde, Germany
Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)
🇩🇪
Berlin, Germany
Kliniken der Friedrich-Alexander-Universität
🇩🇪
Erlangen, Germany
The Onassis Cardiac Center
🇬🇷
Athens, Greece
Presidio Osp. Vito Fazzi
🇮🇹
Lecce, Italy
Università degli Studi di Padova
🇮🇹
Padova, Italy
Ospedale di Portogruaro
🇮🇹
Portogruaro, Italy
Fortis Hospital
🇮🇳
Bangalore, Karnataka, India
CARE Banjara
🇮🇳
Hyderabad, India
Care Institute of Medical Sciences
🇮🇳
Ahmedabad, India
Az.Osp.Universitaria Consorziale Policlinico
🇮🇹
Bari, Italy
Azienda Ospedaliera Di Venere
🇮🇹
Bari, Italy
Policlinico Casilino
🇮🇹
Roma, Italy
Policlinico S.Orsola Malpighi
🇮🇹
Bologna, Italy
Az. Osp. Spedali Civili di Brescia
🇮🇹
Brescia, Italy
Ospedale S. Giovanni Bosco
🇮🇹
Naples, Italy
Az Osp.Universitaria Maggiore della Carità
🇮🇹
Novara, Italy
Casa di Cura Dott. Pederzoli
🇮🇹
Peschiera del Garda, Italy
Ospedale S. Giovanni Calibita Fatebenefratelli di Roma
🇮🇹
Rome, Italy
Azienda Ospedaliera S. Anna
🇮🇹
San Fermo della Battaglia, Italy
Samsung Medical Center
🇰🇷
Seoul, Gangnam-gu, Korea, Republic of
Azienda Ospedaliera "Civile - Maria Paternò Arezzo"
🇮🇹
Ragusa, Italy
Ospedale Madre G. Vannini
🇮🇹
Roma, Italy
Karolinska University Hospital Huddinge
🇸🇪
Stockholm, Sweden
Casa Sollievo della Sofferenza
🇮🇹
San Giovanni Rotondo, Italy
King Fahad Medical City
🇸🇦
Riyadh, Saudi Arabia
Seoul National University Bundang Hospital
🇰🇷
Seongnam-si, Korea, Republic of
Manchester Heart Center, Manchester Royal Infirmary
🇬🇧
Manchester, United Kingdom
Hospital Alvaro Cunqueiro
🇪🇸
Vigo, Spain
HCU Virgen de la Victoria
🇪🇸
Malaga, Spain
Golden Jubilee National Hospital
🇬🇧
Glasgow, United Kingdom
Hospital Universitario Virgen de la Nieves
🇪🇸
Granada, Spain
Seoul St. Mary's Hospital
🇰🇷
Seoul, Seocho-gu, Korea, Republic of
Hospital de Santa Cruz
🇵🇹
Lisbon, Portugal
Twee Steden Ziekenhuis
🇳🇱
Tilburg, Noord-Brabant, Netherlands
Amsterdam Academic Medical Center (AMC)
🇳🇱
Amsterdam, Netherlands
Hospital de la Santa Creu y Sant Pau
🇪🇸
Barcelona, Spain
American University of Beirut Medical Center
🇱🇧
Beirut, Lebanon
Isala Ziekenhuis
🇳🇱
Zwolle, Netherlands
Institut Jantung Negara
🇲🇾
Kuala Lumpur, Malaysia
Catharina Ziekenhuis
🇳🇱
Eindhoven, Netherlands
Hospital Ramon y Cajal
🇪🇸
Madrid, Spain
Southampton General Hospital
🇬🇧
Southampton, United Kingdom
Mater Dei Hospital
🇲🇹
Paola, Malta
Medisch Spectrum Twente
🇳🇱
Enschede, Netherlands
Hospital Garcia de Orta, EPE
🇵🇹
Lisboa, Portugal
Hospital Universitario A Coruña
🇪🇸
A Coruña, Spain
St. Thomas Hospital
🇬🇧
London, United Kingdom
Hospital General Universitario Gregorio Maranon
🇪🇸
Madrid, Spain
National Taiwan University
🇨🇳
Taipei City, Taipei, Taiwan
Chang Gung Memorial Hospital
🇨🇳
LinKou, Taiwan
Wojewodzki Specjalistyczny Szpital im. Bieganskiego
🇵🇱
Lodz, Poland
Complexo Hospitalario Universitario de Santiago
🇪🇸
Madrid, Spain
Queen Elizabeth Hospital
🇬🇧
Birmingham, United Kingdom
Fundación Jiménez Díaz
🇪🇸
Madrid, Spain
CHU Cavale Blanche
🇫🇷
Brest, France
CHRU Lille
🇫🇷
Lille, France
CHU Trousseau
🇫🇷
Chambray-lès-Tours, France
CHU François Mitterrand Dijon Bourgogne
🇫🇷
Dijon, France
CHRU Albert Michallon
🇫🇷
Grenoble, France
Hopital Saint Philibert
🇫🇷
Lomme, France
Institute Cardio. Paris-Sud - Institut Jacques Cartier
🇫🇷
Paris, France
Nouvelles cliniques Nantaises
🇫🇷
Nantes, France
CHU de Nancy - Hopital de Brabois
🇫🇷
Nancy, France
Kings College Hospital
🇬🇧
London, United Kingdom
The Royal Sussex Country Hospital
🇬🇧
Brighton, United Kingdom
Centre Cardiologique Du Nord
🇫🇷
Paris, France
Hopital Pitiè Salpetrière
🇫🇷
Paris, France
Centre Hospitalier de Valence
🇫🇷
Valence, France
CHRU Hôpital de Pontchaillou
🇫🇷
Rennes, France
CHRU Rouen Hospital Charles Nicolle
🇫🇷
Rouen, France
Clinique du Tonkin
🇫🇷
Villeurbanne, France
Institut de Cardiologie de Quebec
🇨🇦
Sainte-Foy, Canada
McGill University Health Centre General Hospital
🇨🇦
Montréal, Canada
Rouge Valley Centenary
🇨🇦
Toronto, Canada
St. Paul's Hospital
🇨🇦
Vancouver, Canada
Sejong General Hospital
🇰🇷
Bucheon-si, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
Hospital Universitari i Politecnic La Fe
🇪🇸
Valencia, Spain
Hospital Universitario Puerta de Hierro
🇪🇸
Madrid, Spain
Hospital Universitario Doce de Octubre
🇪🇸
Madrid, Spain
Hospital Universitario Miguel Servet
🇪🇸
Zaragoza, Spain
Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem
🇩🇪
Göttingen, Niedersachsen, Germany
Medizinische Hochschule Hannover
🇩🇪
Hannover, Niedersachsen, Germany
Medizinische Einrichtungen der Universität zu Köln
🇩🇪
Köln, Nordrhein-Westfalen, Germany
Evangelisches Krankenhaus Kalk gGmbH
🇩🇪
Köln, Nordrhein-Westfalen, Germany
Herz-und Diabetes Zentrum NRW
🇩🇪
Bad Oeynhausen, Germany
Berufsgenossenschaftliche Kliniken Bergmannsheil
🇩🇪
Bochum, Germany
Elisabeth-Krankenhaus Essen GmbH
🇩🇪
Essen, Germany
Klinikum St. Georg gGMbH
🇩🇪
Leipzig, Germany
Klinikum Gütersloh gGmbH
🇩🇪
Gütersloh, Germany
Universitatsklinikum Leipzig
🇩🇪
Leipzig, Germany
Universitätsmedizin Göttingen Georg-August-Universität
🇩🇪
Göttingen, Germany
Albertinen-Krankenhaus Hamburg
🇩🇪
Hamburg, Germany
Klinikum Ludenscheid
🇩🇪
Ludenscheid, Germany
St.-Marien-Hospital GmbH
🇩🇪
Lünen, Germany
Universitatsklinikum Muenster
🇩🇪
Muenster, Germany
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪
München, Germany
Klinikum Oldenburg
🇩🇪
Oldenburg, Germany
Krankenhaus der Barmherzigen Bruder
🇩🇪
Trier, Germany
Universitätsklinikum Würzburg
🇩🇪
Würzburg, Germany
Tel Aviv Medical Center
🇮🇱
Tel Aviv, Israel
Heart Center Research, LLC.
🇺🇸
Huntsville, Alabama, United States
Phoenix Cardiovascular Research Group
🇺🇸
Phoenix, Arizona, United States
Scripps Health
🇺🇸
La Jolla, California, United States
Glendale Adventist Medical Center
🇺🇸
Glendale, California, United States
Comprehensive Cardiovascular
🇺🇸
Bakersfield, California, United States
Eisenhower Medical Center
🇺🇸
Rancho Mirage, California, United States
San Diego Cardiac Center
🇺🇸
San Diego, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸
Reseda, California, United States
Wilhelminenspital
🇦🇹
Vienna, Austria
Prince of Wales Hospital
🇨🇳
Hong Kong, China
CHU Montpellier
🇫🇷
Montpellier, France
Klinikum Ingolstadt
🇩🇪
Ingolstadt, Germany
Kliniken Villingen-Schwenningen
🇩🇪
Villingen-Schwenningen, Germany
Centro Hospitalar Vila Nova Gaia
🇵🇹
Vila Nova de Gaia, Portugal
Hospital Universitario Infanta Cristina
🇪🇸
Badajoz, Spain
Wansbeck General Hospital
🇬🇧
Ashington, United Kingdom
The Great Western Hospital
🇬🇧
Swindon, United Kingdom
John Radcliffe Hospital
🇬🇧
Oxford, United Kingdom
Clínica Cardio VID
🇨🇴
Medellín, Colombia
Keski-Suomi Central Hospital
🇫🇮
Jyvaskyla, Finland
Angiografia Clinica de Occidente
🇨🇴
Cali, Colombia
Krankenhaus der Stadt St. Poelten
🇦🇹
St. Poelten, Austria
Postgraduate Institute of Medical Education & Research
🇮🇳
Chandigarh, India
Hopital Cantonal Universitaire de Geneva
🇨🇭
Geneva, Switzerland
Krankenhaus Hietzing
🇦🇹
Vienna, Austria
Apollo Hospital
🇮🇳
Chennai, India
Arrhythmia Group
🇵🇷
Ponce, Puerto Rico
Sheba Medical Center
🇮🇱
Ramat Gan, Israel
Universitäts-Herzzentrum Freiburg - Bad Krozingen
🇩🇪
Bad Krozingen, Baden-Württemberg, Germany
Medanta Medicity Hospital
🇮🇳
New Delhi, India
Lancaster General Hospital
🇺🇸
Lancaster, Pennsylvania, United States
Hospital de Braga
🇵🇹
Braga, Portugal
Centro Hospitalar do Alto Ave, Unidade de Guimarães
🇵🇹
Creixomil, Portugal
Santa Maria Hospital
🇵🇹
Lisbon, Portugal
King Fahad Armed Forces Hospital
🇸🇦
Jeddah, Saudi Arabia
Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca
🇵🇱
Katowice, Slaskie, Poland
Slaskie Centrum Chorob Serca
🇵🇱
Zabrze, Slask, Poland
Szpital Kliniczny Premienienia Panskiego
🇵🇱
Poznan, Wielkopolskie, Poland