Left Ventricular Septum Pacing in Patients by Transvenous Approach Through the Inter-ventricular Septum

NCT01609738 | Completed DMC

• 2 other identifiers: NL37648.068.11METC 11-1-047
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac pacing is the only effective treatment for symptomatic bradycardia. The right ventricular apex (RVA) has become the most frequently used ventricular pacing site. However, RVA pacing has been shown to cause left ventricular (LV) dyssynchrony wich can lead to LV dysfunction and development of heart failure. Recent studies in animals have demonstrated that pacing at the LV septum induces significantly less ventricular dyssynchrony than RVA pacing and is able to improve LV function to a similar degree as biventricular (BiV) pacing. In addition it was shown that a LV septum lead can be placed permanently by driving a lead with extended helix from the RV side through the inter-ventricular septum into the LV endocardial layer. This was shown to be a feasible and safe procedure and lead stability was shown during four months of follow-up in otherwise healthy and active canines. LV septum pacing may therefore be a good treatment alternative in patients with symptomatic bradycardia, as well as patients with an indication for cardiac resynchronization therapy (CRT). The purpose of this study is to translate the findings from preclinical studies to the clinical situation by investigating the feasibility, long-term lead stability and safety of LV septum pacing by transvenous approach through the inter-ventricular septum in patients.

Conditions

Left Ventricular Dysfunction; Cardiac Conduction Defect; Heart Failure; Sick Sinus Syndrome

Keywords

Cardiac pacing; Left ventricular septal pacing; Feasibility and safety; Lead stability; Hemodynamics; Left ventricular dyssynchrony; Pacing for heart failure; Cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (3)

• Number of successful LV septum lead implantations

  LV septum lead implantation is considered successful if the lead can be placed in the endocardial LV septum and adequate and stable sensing and pacing tresholds are achieved.

  Baseline and 6 months

• Change in sensing values, pacing threshold and lead impedance

  Maintenance of stable lead function is determined by assessment of change in the electrical parameters: sensing value, pacing threshold and lead impedance at baseline versus 6 months follow-up.

  Baseline and 6 months

• Number of participants with procedure or lead related adverse events

  The number of participant with and the kind of procedure- or lead related complications are assessed at the time of the procedure and up to 6 months after lead implantation. Special attention is given to the presence of perforation or rupture of the inter-ventricular septum or free wall, pericardial effusion, thrombosis, heart rhythm disturbances, conduction disturbances, and lead-/screw dislocation/-fracture.

  Baseline and 6 months

Secondary Outcomes (6)

• Acute change in LVdP/dtmax

  Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours

• Acute change in LV stroke volume

  Acute measurements are performed for the duration of the lead implantation procedure, an expected average of two hours

• Acute change in QRS duration

  Baseline and 4 weeks

• Acute change in 3-dimensional QRS vector direction

  Baseline and 4 weeks

• Acute change in SPECKLE-tracking strain

  Baseline and 4 weeks

Study Arms (2)

Sinus node dysfunction

Patients with sinus node dysfunction and structurally normal hearts

Device: Left ventricular septum pacing lead

CRT indication

Patients with an indication for CRT (heart failure with an LVEF \<35% and LBBB)

Device: Left ventricular septum pacing lead

Interventions

Left ventricular septum pacing lead DEVICE

A left ventricular septum pacing lead is permanently placed by introducing a custom lead with extended helix transvenously and, after positioning it against the RV septum, driving it through the inter-ventricular septum into the LV endocardial layer.

Also known as: Adapted Medtronic Select Secure 3830 pacing lead

CRT indication; Sinus node dysfunction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study subjects are recruited from patients referred to the out-patient pacemaker/ICD clinic of our hospital.

You may qualify if:

• Cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker) or indication for CRT (BiV pacemaker).
• Patient with sinus node dysfunction:
• Normal left ventricular ejection fraction (LVEF \> 50%)
• Left ventricular end-diastolic diameter (LVEDD) \< 55mm
• QRS duration \< 100ms
• Patient with CRT indication:
• Non-ischemic cardiomyopathy
• LVEF is \< 35%
• Typical left bundle-branch block on surface ECG
• QRS duration \>150ms
• NYHA functional class I-III
• Greater than 18 years of age
• Willing and capable of giving informed consent

You may not qualify if:

• Ventricular pacing dependent
• High degree AV block
• Previous septal myocardial infarction
• Previously implanted pacing device
• Abnormal venous anatomy
• Left ventricular septum wall thickness \>10mm determined by echocardiography
• Presence of severe valvular disease
• Presence of an ongoing progressive terminal disease associated with a reduced likelihood of survival for the duration of the study

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (10)

• Mills RW, Cornelussen RN, Mulligan LJ, Strik M, Rademakers LM, Skadsberg ND, van Hunnik A, Kuiper M, Lampert A, Delhaas T, Prinzen FW. Left ventricular septal and left ventricular apical pacing chronically maintain cardiac contractile coordination, pump function and efficiency. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):571-9. doi: 10.1161/CIRCEP.109.882910. Epub 2009 Aug 25.

  PMID: 19843926 BACKGROUND

• Peschar M, de Swart H, Michels KJ, Reneman RS, Prinzen FW. Left ventricular septal and apex pacing for optimal pump function in canine hearts. J Am Coll Cardiol. 2003 Apr 2;41(7):1218-26. doi: 10.1016/s0735-1097(03)00091-3.

  PMID: 12679225 BACKGROUND

• Grosfeld MJ, Res JC, Vos DH, de Boer TJ, Bos HJ. Testing a new mechanism for left interventricular septal pacing: the transseptal route; a feasibility and safety study. Europace. 2002 Oct;4(4):439-44. doi: 10.1053/eupc.2002.0253.

  PMID: 12408265 BACKGROUND

• Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, Pedersen AK. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S0140-6736(97)03425-9.

  PMID: 9652562 BACKGROUND

• Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, Kutalek SP, Sharma A; Dual Chamber and VVI Implantable Defibrillator Trial Investigators. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23. doi: 10.1001/jama.288.24.3115.

  PMID: 12495391 BACKGROUND

• Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, Lamas GA; MOde Selection Trial Investigators. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.

  PMID: 12782566 BACKGROUND

• Lamas GA, Lee KL, Sweeney MO, Silverman R, Leon A, Yee R, Marinchak RA, Flaker G, Schron E, Orav EJ, Hellkamp AS, Greer S, McAnulty J, Ellenbogen K, Ehlert F, Freedman RA, Estes NA 3rd, Greenspon A, Goldman L; Mode Selection Trial in Sinus-Node Dysfunction. Ventricular pacing or dual-chamber pacing for sinus-node dysfunction. N Engl J Med. 2002 Jun 13;346(24):1854-62. doi: 10.1056/NEJMoa013040.

  PMID: 12063369 BACKGROUND

• Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, Andrews M, Brown M, Hall WJ, Zareba W, Moss AJ; MADIT II Investigators. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol. 2005 Apr;16(4):359-65. doi: 10.1046/j.1540-8167.2005.50038.x.

  PMID: 15828875 BACKGROUND

• Auricchio A, Stellbrink C, Block M, Sack S, Vogt J, Bakker P, Klein H, Kramer A, Ding J, Salo R, Tockman B, Pochet T, Spinelli J. Effect of pacing chamber and atrioventricular delay on acute systolic function of paced patients with congestive heart failure. The Pacing Therapies for Congestive Heart Failure Study Group. The Guidant Congestive Heart Failure Research Group. Circulation. 1999 Jun 15;99(23):2993-3001. doi: 10.1161/01.cir.99.23.2993.

  PMID: 10368116 BACKGROUND

• Wecke L, Rubulis A, Lundahl G, Rosen MR, Bergfeldt L. Right ventricular pacing-induced electrophysiological remodeling in the human heart and its relationship to cardiac memory. Heart Rhythm. 2007 Dec;4(12):1477-86. doi: 10.1016/j.hrthm.2007.08.001. Epub 2007 Aug 11.

  PMID: 17997360 BACKGROUND

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Cardiac Conduction System Disease; Heart Failure; Sick Sinus Syndrome

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Block; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frits Prinzen, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Kevin Vernooy, MD, PhD

  Maastricht University Medical Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: June 1, 2012
• Study Start: November 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

NL (1)