Simultaneous or Sequential Multipoint Pacing (SCOPE-CRT)
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|ClinicalTrials.gov Identifier: NCT03301363|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : March 26, 2020
|Condition or disease||Intervention/treatment|
|Cardiac Resynchronization Therapy||Device: CRT|
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|
|Estimated Enrollment :||50 participants|
|Official Title:||Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||November 2020|
- Device: CRT
Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System
- Acute QRS duration changes during multipoint CRT [ Time Frame: 1 day during CRT ]Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing.
- Acute ECG QRS duration changes during multipoint CRT [ Time Frame: 1 day during CRT ]
Quantify acute changes in surface ECG QRSd over a range of inter- and intra-ventricular programmable delays setting during multipoint CRT pacing.
- Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT [ Time Frame: 1 day during 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03301363
|Contact: Vincenzo Santinelli, MD||+39 firstname.lastname@example.org|
|Contact: Carlo Pappone, MD||+39 email@example.com|
|IRCCS Policlinico S. Donato||Recruiting|
|San Donato Milanese, Milano, Italy, 20097|
|Contact: Carlo Pappone, MD, PhD 00390252774260 firstname.lastname@example.org|
|Principal Investigator:||Carlo Pappone, MD||IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy|