N/A
Completed N=31
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Source: ClinicalTrials.gov NCT01883141 ↗Enrolled (actual)
31
Serious AEs
16.1%
Results posted
Dec 2018
Primary outcomePrimary: Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing — 28.38; 28.58; 30.05; 31.04 percentage change LV dP/dt max
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing |
28.38; 28.58; 30.05; 31.04; 22.17; 30.05 | — |
| SECONDARY Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing |
28.38; 28.58; 30.05; 22.17; 30.05; 30.83 | — |
| SECONDARY 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 |
31.04; 30.83 | — |
| SECONDARY Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values |
0.63; 0.45; 0.37; 0.23; -0.20; 0.52 | — |
| SECONDARY Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max |
0.33; 0.33 | — |
| SECONDARY Within Patient Variability in Positive LV dP/dt Max |
7.9; 5.6; 7.1; 11.0; 13.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01883141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.