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

Not Applicable

Completed

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

• Registration Number: NCT01510652
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-30
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-16
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-08-14
• Results First Submitted QC: 2015-09-23
• Results First Posted: 2015-10-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1078

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lead Performance	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Implant Duration	Total duration of the implant procedure reported at the end of the procedure	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.
Percentage of Cardiac Resynchronization Therapy Responders	Baseline and 6 months	Percentage of Cardiac Resynchronization Therapy (CRT) responders measured by a decrease of at least 10% of Left Ventricle End-Systolic Volume (LVESV)

Trial Locations

Locations (64)

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

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