Simultaneous or Sequential Multipoint Pacing
SCOPE-CRT
Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedStudy Start
First participant enrolled
November 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 2, 2023
September 1, 2023
5.8 years
September 28, 2017
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Acute ECG QRS duration changes during multipoint CRT
1 day during CRT
Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT
1 day during CRT
Interventions
Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, 20097, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Pappone, MD
IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Arrhythmology Department IRCCS SAn Donato Policlinico, University of Milan, Italy
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 4, 2017
Study Start
November 30, 2017
Primary Completion
September 28, 2023
Study Completion
December 31, 2023
Last Updated
October 2, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share