Simultaneous or Sequential Multipoint Pacing (SCOPE-CRT)

Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Resynchronization Therapy
• Intervention / Treatment: Device: CRT

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Vincenzo Santinelli, MD; Phone Number: +39 0252774260; Email: vincenzo.santinelli@gmail.com
• Study Contact Backup: Name: Carlo Pappone, MD; Phone Number: +39 0252774260; Email: carlo.pappone@af-ablation.org

Study Locations

• Italy
  • Milano
    • San Donato Milanese, Milano, Italy, 20097
      • Recruiting
      • IRCCS Policlinico S. Donato
      • Contact: Carlo Pappone, MD, PhD; Phone Number: 00390252774260; Email: carlo.pappone@af-ablation.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A total of 50 selected heart failure patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA) will be enrolled for this prospective study.

Description

Inclusion Criteria:

• Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA)
• QRS duration > 130 ms
• Ability to provide informed consent for study participation
• At least 18 years of age

Exclusion Criteria:

• Myocardial infarction within 40 days before enrolment

  • NYHA Class IV
  • Tachyarrhythmia caused by temporary or reversible irritation, e.g. poisoning, electrolyte imbalance, hypoxia, sepsis or acute myocardial infarction
  • Such frequent VT or VF that the therapies would cause an unacceptably rapid depletion of the device batteries
  • VT with few or without clinically relevant symptoms
  • VT or VF treatable by surgery
  • Concomitant diseases that would substantially limit a positive prognosis
  • Accelerated intrinsic rhythm
  • Women who are pregnant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute QRS duration changes during multipoint CRT	Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.	1 day during CRT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute ECG QRS duration changes during multipoint CRT	Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing. •	1 day during CRT
Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT	Quantify acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT pacing over a range of inter- and intra-ventricular programmable delays settings.	1 day during CRT

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Donato
• Investigators: Principal Investigator: Carlo Pappone, MD, IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Estimated): September 28, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SCOPE-CRT IRCCSDonato

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No