Left Ventricular MultiSpot Pacing for CRT (iSPOT)

NCT01883141 | Completed Results

• 1 other identifier: iSPOT
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 8

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multispot LV Pacing Configuration Compared to Normal Biventricular Pacing

  Measure the percentage change in positive left ventricular (LV) dP/dt max (mm HG/sec) of multispot LV pacing configuration compared to normal biventricular pacing in patients undergoing a research study, an electrophysiological exploratory procedure or cardiac resynchronization therapy (CRT) implant. The percentage changes correspond to a percentage change between a pacing configuration (pacing on, e.g., Multispot pacing) and baseline (LV pacing off). There are several repetitions of pacing off and on for each pacing configuration. For one repetition, the percentage change is determined as (\[median dP/dt max during pacing On\] - (median baseline dP/dt max during pacing Off\])/\[median dP/dt max during pacing Off\]. From all percentage changes for a given pacing configuration and subject, a regression analysis is performed to determine the regression predicted highest percentage change. The presented percentage change is the average over all subjects.

  Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

Secondary Outcomes (5)

• Percentage Change in Positive Left Ventricular (LV) dP/dt Max (mm HG/Sec) of Multi-vein LV Pacing Configuration Compared to Normal Biventricular Pacing

  Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

• 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

  Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

• Correlation of Blood Pressure, Electrograms (EGMs) and Electrocardiographic Mapping Measurements With the Positive LV dP/dt Max Values

  Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

• Use of Non-invasive Measurements to Identify Pacing Configuration With Highest Positive LV dP/dt Max

  Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

• Within Patient Variability in Positive LV dP/dt Max

  Participants will be followed for the time of the EP procedure, which has an average duration of 2 to 3 hours

Study Arms (1)

Electrophysiological Study

EXPERIMENTAL

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure

Procedure: Electrophysiological Study

Interventions

Electrophysiological Study PROCEDURE

Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots

Electrophysiological Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (8)

Onze-Lieve-Vrouwziekenhuis Aalst

Aalst, 9300, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Barzilai Medical Center

Ashkelon, 78278, Israel

Location

Klinika Choroby Wieńcowej

Warsaw, 02-637, Poland

Location

Klinika Zaburzeń Rytmu Serca

Warsaw, 04-628, Poland

Location

Medical University of Silesia

Zabrze, 44-800, Poland

Location

Guys and St. Thomas NHS Trust

London, SE 1 7EH, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 I NY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29946558 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: CRHF Clinical Research
• Organization: Medtronic, plc

medtroniccrmtrials@medtronic.com

800-328-2518

Study Officials

• Maciej Sterlinski, Dr.

  Warsaw Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: July 2, 2025
• Results First Posted: December 21, 2018

Record last verified: 2018-05

Locations

PL (3); IL (1); BE (2); GB (2)