More Options Available With a Quadripolar LV Lead pRovidE In-clinic Solutions to CRT Challenges

Heart Failure Clinical Trial

— MORE-CRT  

Official title:

More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510652
• Other study ID #: CR-11-006-HF-ID
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1078
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Inappropriate Phrenic Nerve Stimulation
• Left Ventricular Cardiac Dysfunction
• Perioperative/Postoperative Complications
• Postoperative Cardiac Complication
• Postoperative Complications

Intervention

Procedure:
• BiP Group
Implantation of standard Left Ventricular (LV) lead

Device:
• Quad Group
Implantation of quadripolar Left ventricular (LV) lead Quartet

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Hopital La Citadelle	Liège
Canada	Foothills Medical Center	Calgary
Canada	Royal Alexandra Hospital	Edmonton
Canada	QE II Health Sciences	Halifax
Canada	Institut de Cardiologie du Quebec - Hopital Laval	Quebec
Canada	HSC Heastern Health	St. Johns
Finland	Paijat-Hame Central Hospital	Lahti
Finland	Tampere University Hospital	Tampere
France	CHU La Cavale Blanche	Brest
France	CHU Gabriel Montpied	Clermont-Ferrand
France	CHRU Hopital Albert Michallon	Grenoble
France	Hopital Cardiovasculaire et Pneumologique Louis Pradel	Lyon
France	Hopital de la Timone	Marseille
France	Hopital du Nord - CH Bourrely St. Antoine	Marseille
France	CHU Hopital G&R Laennec	Nantes
France	Nouvelles Cliniques Nantaises	Nantes
France	CHRU Hopital de Pontchaillou	Rennes
France	CHRU Hopital Charles Nicolle	Rouen
France	CHU St. Etienne	Saint Priest en Jarez
France	Clinique du Tonkin	Villeurbanne
Germany	Charite Campus Virchow Klinikum	Berlin
Germany	Unfallkrankenhaus Berlin-Marzahn	Berlin
Germany	Stadtische Kliniken Bielefeld	Bielefeld
Germany	Klinikum Coburg	Coburg
Germany	Elisabeth-Krankenhaus	Essen
Germany	Universitatsklinikum Greifswald	Greifswald
Germany	Universitatskliniken des Saarlandes	Homburg
Germany	Universitatsklinikum Leipzig	Leipzig
Germany	Klinikum Ludenscheid	Ludenscheid
Germany	Stadtisches Klinikum Ludwigshafen	Ludwigshafen
Germany	Krankenhaus der Barmherzigen	Trier
India	All India Institute of Medical Sciences	New Delhi
India	Escorts Heart Institute and Research Center	New Delhi
Israel	Barzilai Medical Center	Ashkelon
Israel	Soroka University Hospital	Beer Sheba
Israel	Kaplan Medical Center	Rehovot
Israel	Sheba Medical Center	Tel Hashomer
Italy	Policlinico S. Orsola & Malpighi	Bologna
Italy	Azienda Ospedaliera S.Anna e S.Sebastiano	Caserta
Italy	Azienda Ospedaliera Mater Domini	Catanzaro
Italy	Ospedale Vito Fazzi	Lecce
Italy	Ospedale Maggiore della Carità	Novara
Italy	Policlinico Casilino	Rome
Italy	Ospedale SS. Annunziata	Taranto
Italy	Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista	Torino
Italy	Ospedale Civile Maggiore Verona Borgo Trento	Verona
Netherlands	Amphia Hospital	Breda
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	MC Haaglanden	Den Haag
Netherlands	Medisch Spectrum Twente	Enschede
Poland	Slaskie Centrum Chorob Serca	Zabrze
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitari La Fe	Valencia
Switzerland	Basel University Hospital	Basel
Switzerland	Hopital Cantonal Universitaire de Geneva	Geneva
Switzerland	Fondazione Cardiocentro Ticino	Lugano
Switzerland	Universitaets Spital Zuerich	Zurich
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	St. Thomas Hospital	London
United Kingdom	James Cook University Hospital	Middlesbrough

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Belgium,  Canada,  Finland,  France,  Germany,  India,  Israel,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead Performance	Percentage of patients with freedom from event (intra- and post-operative). Intra-operative events were defined as: need to use more than 1 left ventricular lead, need to change lead implant position, use of any device to actively fixate the lead, unsuccessful implant, due to phrenic nerve stimulation, high pacing threshold or lead instability.; Post-operative events were defined as any left ventricular lead related serious adverse device effect and CRT switched off.	6 months
Secondary	Percentage of Cardiac Resynchronization Therapy Responders	Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)	Baseline and 6 months
Secondary	Implant Duration	This measure reports the length (in time) of the implantation procedure. The measurement start at skin incision and stop at skin suture (so called skin-to-skin time) The total implant procedure duration time will be compared between the control and the treatment group.	Total duration of the implant procedure reported at the end of the procedure