Clinical trial NCT01510652: More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges
Official title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cardiac Complication
Heart Failure
Left Ventricular Cardiac Dysfunction
Inappropriate Phrenic Nerve Stimulation
Perioperative/Postoperative Complications
Keywords: Cardiac Resynchronization therapy,
Heart Failure,
Left Ventricular Lead,
Quadripolar Left ventricular Lead,
Phrenic Nerve Stimulation,
Intra and post operative related complications
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-01-16
Enrollment: 1078
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.


Eligibility criteria: Inclusion Criteria:

* Patients are indicated for Cardiac Resynchronization Therapy with Defibrillation backup device (CRT-D) implantation, as per current international certified guidelines
* Patients age is 18 years or greater
* Patients must indicate their understanding of the study and willingness to participate by signing the appropriate informed consent form
* Patients must be willing and able to comply with all study requirements

Exclusion Criteria:

* Patients with a life expectancy \<12 months.
* Patients who are or may potentially be pregnant.
* Patient has suffered any of the following in the 4 weeks prior to enrolment:

  * Myocardial Infarction (MI)
  * Coronary Artery Bypass Graft (CABG)
  * Unstable Angina Pectoris
* Patient has primary valvular disease which has not been corrected

Primary outcomes:
measure: Lead Performance
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Cardiac Resynchronization Therapy Responders
timeFrame: Baseline and 6 months
measure: Implant Duration
timeFrame: Total duration of the implant procedure reported at the end of the procedure
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Liège
country: Belgium
facility: Hopital La Citadelle
city: Calgary
country: Canada
facility: Foothills Medical Center
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
city: Halifax
country: Canada
facility: QE II Health Sciences
city: Quebec
country: Canada
facility: Institut de Cardiologie du Quebec - Hopital Laval
city: St. Johns
country: Canada
facility: HSC Heastern Health
city: Lahti
country: Finland
facility: Paijat-Hame Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Brest
country: France
facility: CHU La Cavale Blanche
city: Clermont-Ferrand
country: France
facility: CHU Gabriel Montpied
city: Grenoble
country: France
facility: CHRU Hopital Albert Michallon
city: Lyon
country: France
facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel
city: Marseille
country: France
facility: Hopital de la Timone
city: Marseille
country: France
facility: Hopital du Nord - CH Bourrely St. Antoine
city: Nantes
country: France
facility: CHU Hopital G&R Laennec
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Rennes
country: France
facility: CHRU Hopital de Pontchaillou
city: Rouen
country: France
facility: CHRU Hopital Charles Nicolle
city: Saint Priest en Jarez
country: France
facility: CHU St. Etienne
city: Villeurbanne
country: France
facility: Clinique du Tonkin
city: Berlin
country: Germany
facility: Charite Campus Virchow Klinikum
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin-Marzahn
city: Bielefeld
country: Germany
facility: Stadtische Kliniken Bielefeld
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
city: Greifswald
country: Germany
facility: Universitatsklinikum Greifswald
city: Homburg
country: Germany
facility: Universitatskliniken des Saarlandes
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Ludenscheid
country: Germany
facility: Klinikum Ludenscheid
city: Ludwigshafen
country: Germany
facility: Stadtisches Klinikum Ludwigshafen
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Escorts Heart Institute and Research Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheba
country: Israel
facility: Soroka University Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Bologna
country: Italy
facility: Policlinico S. Orsola & Malpighi
city: Caserta
country: Italy
facility: Azienda Ospedaliera S.Anna e S.Sebastiano
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Novara
country: Italy
facility: Ospedale Maggiore della Carità
city: Rome
country: Italy
facility: Policlinico Casilino
city: Taranto
country: Italy
facility: Ospedale SS. Annunziata
city: Torino
country: Italy
facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista
city: Verona
country: Italy
facility: Ospedale Civile Maggiore Verona Borgo Trento
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Zabrze
country: Poland
facility: Slaskie Centrum Chorob Serca
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Valencia
country: Spain
facility: Hospital Universitari La Fe
city: Basel
country: Switzerland
facility: Basel University Hospital
city: Geneva
country: Switzerland
facility: Hopital Cantonal Universitaire de Geneva
city: Lugano
country: Switzerland
facility: Fondazione Cardiocentro Ticino
city: Zurich
country: Switzerland
facility: Universitaets Spital Zuerich
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: London
country: United Kingdom
facility: St. Thomas Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy
name: Giuseppe Boriani, Pro.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.