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

Abbott

Status: Completed

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

Treatments: Procedure: BiP Group; Device: Quad Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT01510652

CR-11-006-HF-ID

Details and patient eligibility

About

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.

Enrollment: 1,078 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,078 participants in 2 patient groups

Quad Group

Active Comparator group

Description:

Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet

Treatment:

Device: Quad Group

BiP Group

Active Comparator group

Description:

Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)

Treatment:

Procedure: BiP Group