NCT03301363

Simultaneous or Sequential Multipoint Pacing

Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare electrical acute changes between simultaneous and sequential LV pacing and to assess the paced QRSd over a range of inter- and intra-ventricular programmable delays setting during MPP pacing.

Detailed description

The study will be a prospective, single-arm, non-randomized, non-blinded, acute study conducted at CRT device implant and prior to subject discharge. Subjects scheduled to be implanted with a Quadripolar Pacing System who provide informed consent will undergo "Enrollment" and participate in "SCOPE-CRT" study. Enrollment and device implant can occur in the same day. Including Enrollment, each subject's participation is expected to be 1-2 days. The total duration of the study is expected to be 12 months, including Enrollment. Enrollment will include the Informed Consent process, physical examination, and collection of demographics, cardiovascular history, medical history, and medications. During CRT implant, surface ECG and PV loop recordings will be taken over the different programmable MPP settings. Following data collection, CRT device programming will be left to the discretion of the physician.

Conditions

• Cardiac Resynchronization Therapy

Interventions

Type	Name	Description
DEVICE	CRT	Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System

Timeline

• Start date: 2017-11-30
• Primary completion: 2023-09-28
• Completion: 2023-12-31
• First posted: 2017-10-04
• Last updated: 2023-10-02

Locations

1 site across 1 country: Italy