Clinical trial NCT03301363: Simultaneous or Sequential Multipoint Pacing
Official title: Simultaneous Or Sequential multiPoint Pacing in Cardiac Resynchronization Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Resynchronization Therapy
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute QRS duration changes during multipoint CRT
timeFrame: 1 day during CRT
Secondary outcomes:
measure: Acute ECG QRS duration changes during multipoint CRT
timeFrame: 1 day during CRT
measure: Acute changes in hemodynamics between simultaneous and sequential LV pacing during multipoint CRT
timeFrame: 1 day during CRT
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico S. Donato
state: Milano
Study officials:
affiliation: IRCCS San Donato University Hospital Policlinico San Donato, Milan, Italy
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
References: