Simultaneous or Sequential Multipoint Pacing

NCT ID: NCT03301363

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CRT

Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Policlinico S. Donato

OTHER

Sponsor Role: lead

Responsible Party

Carlo Pappone

Chief of Arrhythmology Department IRCCS SAn Donato Policlinico, University of Milan, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Pappone, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy

Locations

IRCCS Policlinico S. Donato

San Donato Milanese, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo Santinelli, MD

Role: CONTACT

vincenzo.santinelli@gmail.com

+39 0252774260

Carlo Pappone, MD

Role: CONTACT

carlo.pappone@af-ablation.org

+39 0252774260

Facility Contacts

Carlo Pappone, MD, PhD

Role: primary

carlo.pappone@af-ablation.org

00390252774260

Other Identifiers

SCOPE-CRT IRCCSDonato

Identifier Type: -

Identifier Source: org_study_id