Clinical trial NCT01883141: Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Official title: Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).


Eligibility criteria: Inclusion Criteria:

* Subject is indicated for cardiac CRT or CRT-D device according to current applicable European Society of Cardiology (ESC)/American Heart Association (AHA) guidelines
* Subject has a left bundle branch block (LBBB) conduction pattern
* Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (AF) episodes allowed during the last 2 weeks prior to inclusion)
* Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or angiotensin receptor blockers (ARB) and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
* Subject (or the legal guardian) is willing to sign informed consent form
* Subject is 18 years or older or as specified minimal age per local law/regulation

Exclusion Criteria:

* Subject has permanent atrial fibrillation/ flutter or tachycardia
* Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
* Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation, or is actively listed on the transplantation list
* Subject is implanted with a left ventricular assist device (LVAD)
* Subject is on chronic renal dialysis
* Subject has severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) \< 30 mL/min/1.73m2)
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period)
* Subject has complex and uncorrected congenital heart disease
* Subject has a mechanical heart valve
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
* Subject is enrolled in one or more concurrent studies that would confound the results of this study
* Subject is already implanted with a device

Primary outcomes:
measure: Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing
timeFrame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Secondary outcomes:
measure: Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing
timeFrame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
measure: Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Multispot LV Pacing Configuration
timeFrame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
measure: Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values
timeFrame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
measure: Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max
timeFrame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
measure: Within Patient Variability in Positive LV dP/dt Max
timeFrame: Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Warsaw
country: Poland
facility: Klinika Choroby Wieńcowej
city: Warsaw
country: Poland
facility: Klinika Zaburzeń Rytmu Serca
city: Zabrze
country: Poland
facility: Medical University of Silesia
city: London
country: United Kingdom
facility: Guys and St. Thomas NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Warsaw Hospital
name: Maciej Sterlinski, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson T, Lenarczyk R, Sterlinski M, Sokal A, Francis D, Whinnett Z, Van Heuverswyn F, Vanderheyden M, Heynens J, Stegemann B, Cornelussen R, Rinaldi CA. Left ventricular scar and the acute hemodynamic effects of multivein and multipolar pacing in cardiac resynchronization. Int J Cardiol Heart Vasc. 2018 Apr 10;19:14-19. doi: 10.1016/j.ijcha.2018.03.006. eCollection 2018 Jun.