Simultaneous or Sequential Multipoint Pacing

Cardiac Resynchronization Therapy Clinical Trial

— SCOPE-CRT  

Official title:

Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301363
• Other study ID #: SCOPE-CRT IRCCSDonato
• Status: Recruiting
• Start date: November 30, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Vincenzo Santinelli, MD
• Phone: +39 0252774260
• Email: vincenzo.santinelli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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