Heart Failure Study of Multi-site Pacing Effects on Ventriculoarterial Coupling

NCT03189368 | Completed FDA Device

• 1 other identifier: HippoCT1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To perform a comparative study of multi-site left ventricular pacing and cardiac resynchronization therapy effects on ventriculoarterial coupling and energy efficiency of the failing heart

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy; Multi-site Pacing; Ventriculoarterial Coupling; Energy Efficiency

Outcome Measures

Primary Outcomes (2)

• Improvement of ventriculoarterial coupling

  Ventriculoarterial coupling value shifts closer to 1

  6 months for each intervention (conventional CRT - MPP)

• Improvement of energy efficiency

  Energy efficiency improvement will be assessed by means of ventriculoarterial coupling value shifts closer to 0.7

  6 months for each intervention (conventional CRT - MPP)

Secondary Outcomes (2)

• Improvement in renal function

  6 months for each intervention (conventional CRT - MPP)

• Improvement in percent maximal stroke work

  6 months for each intervention (conventional CRT - MPP)

Study Arms (1)

Heart failure patients eligible for CRT

Adult, consenting patients with any cardiomyopathy type and an existing I/IIa indication for a CRT-D device will receive a device with multi-site pacing capability. Initially, for 6 months, optimal, conventional, resynchronization therapy will be delivered. Following this, all patients will crossover to optimized multi-site pacing, and receive this therapy for 6 more months. Optimization of therapy will be determined based on maximization of cardiac output, i.e. maximization of left ventricular outflow tract velocity-time integral. Baseline measurements of serum creatinine and ventriculoarterial coupling will also be acquired.

Device: Activation of multi-site pacing capability on CRT devices

Interventions

Activation of multi-site pacing capability on CRT devices DEVICE

Instead of administering a single LV pulse at the most (electrically) delayed segment of the ventricle, multi-site pacing allows for a more detailed "sculpting" of the LV activation sequence. Based on the MPP-IDE study results, activation of the antero-lateral wall, or at least its most delayed segments, closely followed by a pulse to the apex and then by a right ventricular one will yield favorable results in terms of hemodynamics and clinical parameters. Programming features: * Interpolar distance for the first left ventricular pulse \>30mm (i.e. non-sequential poles used) * Nearly simultaneous (Δt=5msec) second left ventricular pulse and * Threshold of ≤3.5V@0.5msec

Heart failure patients eligible for CRT

Eligibility Criteria

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

Study Population

Systolic heart failure with an ejection fraction of 35% or less, at NYHA functional class of II or worse, and a QRS displaying either LBBB morphology and \>120msec or non-LBBB morphology and \>150msec.

You may qualify if:

• Adult (\>18 years of age), consenting patients
• Any cardiomyopathy type and
• An existing I/IIa indication for a CRT-D device

You may not qualify if:

• Those with a class IIb CRT indication
• Those where thresholds of \<3.5V@0.5msec cannot be achieved in at least two dipoles of the left pacing electrode
• Those where no dipole with a distance between poles of 30mm can be detected
• Those with \>2/4 (moderate to severe - severe) mitral/aortic insufficiency, rendering noninvasive VAC calculation unreliable.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

First Department of Cardiology, Hippokration General Hospital

Athens, Attica, 11527, Greece

Location

Related Publications (1)

• Chrysohoou C, Dilaveris P, Antoniou CK, Skiadas I, Konstantinou K, Gatzoulis K, Kallikazaros I, Tousoulis D. Heart failure study of multipoint pacing effects on ventriculoarterial coupling: Rationale and design of the HUMVEE trial. Ann Noninvasive Electrocardiol. 2018 May;23(3):e12510. doi: 10.1111/anec.12510. Epub 2017 Oct 15.

  PMID: 29034563 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiology, First Department of Cardiology, Hippokrateion General Hospital

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 16, 2017
• Study Start: September 18, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)