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OpenTrials
Completed

NCT Number: NCT01510652

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

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.

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Key information

Conditions

Postoperative Cardiac Complication Cardiovascular Diseases Heart Diseases Heart Failure Inappropriate Phrenic Nerve Stimulation Left Ventricular Cardiac Dysfunction Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BiP Group

Procedure

Implantation of standard Left Ventricular (LV) lead

Quad Group

Device

Implantation of quadripolar Left ventricular (LV) lead Quartet

Primary outcomes

  1. Lead Performance

    Time frame: 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 outcomes

  1. Percentage of Cardiac Resynchronization Therapy Responders

    Time frame: 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)

  2. Implant Duration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: MORE-CRT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2012
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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