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

Information source: St. Jude Medical
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Cardiac Complication; Heart Failure,; Left Ventricular Cardiac Dysfunction; Inappropriate Phrenic Nerve Stimulation; Perioperative/Postoperative Complications

Intervention: Standard Left Ventricular (LV) lead (Procedure); Quartet Left Ventricular (LV) lead (Device)

Phase: N/A

Status: Completed

Sponsored by: St. Jude Medical

Official(s) and/or principal investigator(s):
Giuseppe Boriani, Pro., Principal Investigator, Affiliation: Policlinico Universitario S. Orsola e Malpighi, Bologna, Italy

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Lead performance

Secondary outcome:

Percentage of Cardiac Resynchronization Therapy responders

Implant duration

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Ziekenhuis Oost-Limburg, Genk, Belgium

Hopital La Citadelle, Liège, Belgium

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, Canada

Paijat-Hame Central Hospital, Lahti, Finland

Tampere University Hospital, Tampere, Finland

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, France

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, Germany

All India Institute of Medical Sciences, New Delhi, India

Escorts Heart Institute and Research Center, New Delhi, India

Barzilai Medical Center, Ashkelon, Israel

Soroka University Hospital, Beer Sheba, Israel

Kaplan Medical Center, Rehovot, Israel

Sheba Medical Center, Tel Hashomer, Israel

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, Italy

Amphia Hospital, Breda, Netherlands

Haga Ziekenhuis, Den Haag, Netherlands

MC Haaglanden, Den Haag, Netherlands

Medisch Spectrum Twente, Enschede, Netherlands

Slaskie Centrum Chorob Serca, Zabrze, Poland

Hospital de Basurto, Bilbao, Spain

Hospital Ramon y Cajal, Madrid, Spain

Hospital Universitari La Fe, Valencia, Spain

Basel University Hospital, Basel, Switzerland

Hopital Cantonal Universitaire de Geneva, Geneva, Switzerland

Fondazione Cardiocentro Ticino, Lugano, Switzerland

Universitaets Spital Zuerich, Zurich, Switzerland

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, United Kingdom

Additional Information

Starting date: November 2011
Last updated: September 18, 2014

Page last updated: August 23, 2015

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