Triple-site Biventricular Stimulation in the Optimization of CRT

NCT02350842 | Completed

• 1 other identifier: ICSY02
• Study Type: interventional
• Target: 30
• Locations: 6 countries
• Sites: 14

Brief Summary

Cardiac resynchronization is a recommended therapy for patients with advanced heart failure, under optimized medical treatment with reduced left ventricular ejection fraction and prolonged QRS, nevertheless, still 30% of the population do not respond to standard biventricular implantation. Non-response can be explained by a combination of factors including sub-optimal patient selection, placement of the pacing lead over a zone of slow conduction, insufficient correction of mechanical dyssynchrony including sub-optimal lead implantation. Few data distinguish true non-responders from patients in which effective resynchronization was not delivered through standard biventricular implantation. Triple-site cardiac resynchronization pacing (stimulation at three ventricular sites) has been proposed to improve synchrony and thus the response rate in (Cardiac Resynchronisation Therapy) CRT recipients.

Conditions

Heart Failure

Keywords

non-Left Bundle Branch Block morphology; Triple-site biventricular pacing; cardiac resynchronization therapy

Outcome Measures

Primary Outcomes (1)

• TriV pacing is superior to standard BiV pacing in reversing ventricular modeling as demonstrated by Echo LVESV at 12 months in pts. with non LBBB without increasing the risk of serious events at 30 days.

  The efficacy endpoint for this study is the change in LVESV at twelve months post-implant between individually optimized, triple-site biventricular pacing and standard biventricular pacing. LVESV is a standard marker of CRT effectiveness1. Echocardiographic data collected at twelve months follow-up will document the evolution of LVESV as compared to baseline in order to assess reverse ventricular remodeling. The safety endpoint for this study is the rate of all serious procedure and/or device related events reported at thirty days post-implant.

  12 months

Secondary Outcomes (4)

• Evaluate serious device related complications at six and twelve months post-procedure.

  6 and 12 months

• Evaluate reverse ventricular remodeling response based on additional echocardiographic measures

  6 and 12 months

• Evaluate patient's clinical status considering New York Heart Association (NYHA) functional class improvement

  6 and 12 months

• Evaluate mortality and serious heart failure (HF) events during the procedure through discharge and at the different follow-up time-points.

  1, 6 and 12 months

Study Arms (2)

Triple-site biventricular pacing

EXPERIMENTAL

Triple-site biventricular pacing with individual optimization of the placement of the third lead by peri-operative echo guidance. Devices used will be the Sorin, locally approved and commercially available Paradym SonR Tri-V CRT-D.

Device: triple-site biventricular pacing with peri-operative echo guidance

Standard biventricular pacing

ACTIVE COMPARATOR

Standard biventricular pacing (1RV/1LV) through classical implantation procedure without peri-operative optimization. Devices used will be locally approved and commercially available Sorin implantable cardioverter defibrillators.

Device: standard biventricular pacing

Interventions

triple-site biventricular pacing with peri-operative echo guidance DEVICE

placement of the third lead by peri-operative echo guidance.

Triple-site biventricular pacing

standard biventricular pacing DEVICE

standard biventricular pacing without optimization by echo guidance

Standard biventricular pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Stable heart failure with New York Heart Association (NYHA) functional class II, III or ambulatory IV
• Stable optimized medical regimen according to medical guidelines (No change in heart failure medication for at least 1 month prior to enrollment)
• Left ventricular ejection fraction (LVEF) ≤ 35%
• Intrinsic QRS duration ≥ 140 msec
• Non-typical left bundle branch block (LBBB) morphology on 12-lead surface ECG
• Signed and dated informed consent

You may not qualify if:

• Typical LBBB according to Strauss criteria
• Unstable heart failure
• Permanent or long-lasting persistent Atrial Fibrillation
• Unstable angina, acute Myocardial Infarction (MI), Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within 90 days prior to enrollment (intervention)
• Conventional pacemaker indication
• Previous implant with a pacemaker or an Implantable Cardioverter-Defibrillator (ICD)
• Renal Failure (Glomerular filtration rate (GFR) \< 30 ml/min/1.73m2)
• Pregnant women
• Already included in another clinical study that could confound the results of this study
• Life expectancy \< 12 months
• Mechanical heart valve or indication for valve repair or replacement
• Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months)
• Heart transplant

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (14)

CHRU Hopital Sud

Amiens, 80054, France

Location

Clinique Rhone Durance

Avignon, 84082, France

Location

Hopital Jean Minjoz Besançon

Besançon, 25030, France

Location

CHRU Brest

Brest, 29609, France

Location

Groupe hospitalier Paris Saint-Joseph

Paris, 75614, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU Hôpital Charles Nicolle

Rouen, 76031, France

Location

CHU Toulouse, Hopital Rangueil

Toulouse, 31400, France

Location

Universitaetsklinikum Schleswig Holstein

Kiel, D-24105, Germany

Location

Humanitas Cliniche Gavazzeni spa

Bergamo, 24125, Italy

Location

Isala Zwolle

Zwolle, 8025AB, Netherlands

Location

CHCL - Hospital Santa Marta

Lisbon, 1169-024, Portugal

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8025, Spain

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jean-Claude Daubert, MD

  Hôpital Pontchaillou-CHU Rennes, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: January 30, 2015
• Study Start: July 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: April 25, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

NL (1); IT (1); FR (8); PT (1); DE (1); ES (2)