Clinical trial NCT01564186: Characterization of Cardiac Hemodynamics During MultiSite Pacing
Official title: Characterization of Cardiac Hemodynamics by Pressure-Volume Loop Analysis During MultiPoint Pacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-03-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for standard CRT-D therapy.

Brief summary: The purpose of this study is to evaluate the effects of MultiPoint Pacing (MPP) on cardiac hemodynamics assessed by pressure-volume loop during MPP at implant. NYHA functional class assessment and echocardiographic measurements are performed at 3 months and 12 months post-implant to characterize long-term effect of MPP.


Eligibility criteria: Inclusion Criteria:

* Be scheduled to undergo implant of a St Jude Medical CRT-D system with approved standard indication by ESC/EHRA Guidelines
* Be in sinus rhythm at the time of enrollment
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

* Exhibit Cheyne-Stokes respiration
* Have persistent or permanent atrial fibrillation
* Have complete heart block
* Be in NYHA IV functional class
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be less than 18 years of age
* Be pregnant

Primary outcomes:
measure: Within-patient differences in PV loop-based hemodynamic parameters (dP/dtMax, stroke work, stroke volume, ejection fraction)
timeFrame: At implant
Secondary outcomes:
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
Study officials:
affiliation: Maria Cecilia Hospital
name: Carlo Pappone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Jordan CD, Romano E, Baldi M, Saviano M, Pappone A, Vitale R, Catalano C, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Fragakis N, Fundaliotis A, Tavazzi L, Santinelli V. Improving cardiac resynchronization therapy response with multipoint left ventricular pacing: Twelve-month follow-up study. Heart Rhythm. 2015 Jun;12(6):1250-8. doi: 10.1016/j.hrthm.2015.02.008. Epub 2015 Feb 9.
citation: Pappone C, Calovic Z, Vicedomini G, Cuko A, McSpadden LC, Ryu K, Romano E, Baldi M, Saviano M, Pappone A, Ciaccio C, Giannelli L, Ionescu B, Petretta A, Vitale R, Fundaliotis A, Tavazzi L, Santinelli V. Multipoint left ventricular pacing in a single coronary sinus branch improves mid-term echocardiographic and clinical response to cardiac resynchronization therapy. J Cardiovasc Electrophysiol. 2015 Jan;26(1):58-63. doi: 10.1111/jce.12513. Epub 2014 Sep 19.