NCT02126241

Brief Summary

This proposal aims to evaluate the added clinical and echocardiographic benefit of using the non-invasive impedance-based cardiac output measurement system (NICaS) for optimizing atrio-ventricular and inter-ventricular delays in chronic (more than 6 months) CRT recipients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

7 months

First QC Date

April 27, 2014

Last Update Submit

August 5, 2015

Conditions

Congestive Heart Failure

Keywords

Heart FailureCardiac Resyncronization TherapyOptimizationNon-invasive cardiac systemImpedance measured cardiac output

Outcome Measures

Primary Outcomes (1)

  • Predictors for significant cardiac output improvement

    Using logistic regression, we will look for predictors (clinical, ECG, echocardiographic, hemodynamic) of significant (at least 20%) acute cardiac output improvement (as assessed by NICaS), after NICaS guided AV and VV delays optimization.

    Within the first year after beginning of study

Secondary Outcomes (5)

  • Acute six-minute walk test changes after NICaS optimization

    Within the first 24 hours after enrollment

  • Reverse remodeling

    At 6 months after enrollment

  • Hospitalization rate for heart failure

    Within the first 6 months after enrollment

  • Supraventricular arrhythmia occurrence

    At 6 months after enrollment

  • Clinical improvement

    At 6 months after enrollment

Study Arms (1)

NICaS guided CRT optimization

EXPERIMENTAL

For each subject, we will determine a set of AV and VV delays values, for which the NICaS measured CO will be maximum. In each patient, the CRT device will then be programmed according to these values.

Other: NICaS guided CRT optimization

Interventions

NICaS guided CRT optimizationOTHER

1. Baseline CO measurement by NICaS 2. AV delay optimization: 1. AV delay will be changed (increase and decrease) by 30 ms steps , and for each new AV value, the CO will be real-time measured by NICaS 2. The AV delay yielding the maximal CO, will be considered the optimal AV delay 3. The device will be programmed using the optimal AV delay 3. VV delay optimization: 1. After Step 2, the baseline VV delay will be changed (increase and decrease; meaning that we will be pacing alternatively the LV before the RV, then the RV before the LV), by 30 ms steps, and for each new VV value, the CO will be real-time measured by NICaS 2. The VV delay yielding the maximal CO, will be considered the optimal VV delay 3. The device will be programmed using the optimal VV delay

NICaS guided CRT optimization

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients implanted with a CRT device at least 6 months before, in concordance with AHA/ACC or ESC/EHRA Guidelines (Class I or II) for CRT implantation
  • NYHA class I - III heart failure
  • Stable sinus rhythm
  • Bi-ventricular pacing ≥ 90%
  • Patient provides informed consent.

You may not qualify if:

  • NYHA class IV heart failure
  • Permanent or persistent atrial fibrillation
  • Bi-ventricular pacing \<90%
  • Inability to perform the six-minute walk test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (5)

  • Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.

    PMID: 23801822BACKGROUND

  • Delnoy PP, Ritter P, Naegele H, Orazi S, Szwed H, Zupan I, Goscinska-Bis K, Anselme F, Martino M, Padeletti L. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study. Europace. 2013 Aug;15(8):1174-81. doi: 10.1093/europace/eut034. Epub 2013 Mar 14.

    PMID: 23493410BACKGROUND

  • Tanino Y, Shite J, Paredes OL, Shinke T, Ogasawara D, Sawada T, Kawamori H, Miyoshi N, Kato H, Yoshino N, Hirata K. Whole body bioimpedance monitoring for outpatient chronic heart failure follow up. Circ J. 2009 Jun;73(6):1074-9. doi: 10.1253/circj.cj-08-0847. Epub 2009 Apr 16.

    PMID: 19372625BACKGROUND

  • Heinroth KM, Elster M, Nuding S, Schlegel F, Christoph A, Carter J, Buerke M, Werdan K. Impedance cardiography: a useful and reliable tool in optimization of cardiac resynchronization devices. Europace. 2007 Sep;9(9):744-50. doi: 10.1093/europace/eum086. Epub 2007 May 11.

    PMID: 17496288BACKGROUND

  • Turcott RG, Witteles RM, Wang PJ, Vagelos RH, Fowler MB, Ashley EA. Measurement precision in the optimization of cardiac resynchronization therapy. Circ Heart Fail. 2010 May;3(3):395-404. doi: 10.1161/CIRCHEARTFAILURE.109.900076. Epub 2010 Feb 22.

    PMID: 20176716BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michael Glikson, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 27, 2014

First Posted

April 29, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

IL(1)