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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT | Device | Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Myocardial infarction within 40 days before enrolment
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Santinelli, MD | Contact | +39 0252774260 | vincenzo.santinelli@gmail.com | |
| Carlo Pappone, MD | Contact | +39 0252774260 | carlo.pappone@af-ablation.org |
| Name | Affiliation | Role |
|---|---|---|
| Carlo Pappone, MD | IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S. Donato | Recruiting | San Donato Milanese | Milano | 20097 | Italy |
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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 |