QP ExCELs: MultiPole Pacing (MPP) Sub-Study

Biotronik

Status: Completed

Conditions: Heart Failure

Treatments: Device: MultiPole Pacing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03155724

MPP Sub-Study

Details and patient eligibility

About

The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently enrolled in the ongoing QP ExCELs study
• Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or future-marketed CRT-D system with the MPP feature. Successful implantation is defined as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @ any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve stimulation at the final programmed pacing output at the time of enrollment into the MPP sub-study.
• CRT Responder Assessment classification as "Worsened" or "Unchanged"
• Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a Heart Failure (HF) hospitalization event)
• Able to understand the nature of the sub-study and give informed consent
• Available for an additional follow-up visit specific to the MPP sub-study at the investigational site
• No evidence of non-compliance to their ongoing commitment in the QP ExCELs study

Exclusion criteria

• Have a life expectancy of less than 6 months
• Expected to receive heart transplantation or ventricular assist device within 6 months
• Chronic atrial fibrillation
• Presence of another life-threatening, underlying illness separate from their cardiac disorder
• Received MPP pacing prior to enrolment into the MPP sub-study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

53 participants in 1 patient group

MultiPole Pacing

Experimental group

Description:

Traditional biventricular pacing CRT non-responders at the 3 or 6 month QP ExCELs study follow-up.

Treatment:

Device: MultiPole Pacing