Status:
COMPLETED
Left Ventricular MultiSpot Pacing for CRT (iSPOT)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01883141
Start Date
June 1 2013
End Date
April 1 2015
Last Update
July 2 2025
Active Locations (8)
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1
Onze-Lieve-Vrouwziekenhuis Aalst
Aalst, Belgium, 9300
2
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
3
Barzilai Medical Center
Ashkelon, Israel, 78278
4
Klinika Choroby Wieńcowej
Warsaw, Poland, 02-637