Cardiac Resynchronization Therapy
Conditions
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.
Interventions
DEVICECRT
Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System
Sponsors
IRCCS Policlinico S. Donato
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute QRS duration changes during multipoint CRT | 1 day during CRT | Quantify acute changes in surface ECG QRS duration between simultaneous and sequential LV pacing during MPP pacing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute ECG QRS duration changes during multipoint CRT | 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 | 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. |
Countries
Italy
Contacts
Primary ContactVincenzo Santinelli, MD
Backup ContactCarlo Pappone, MD
Outcome results
None listed