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Completed

NCT Number: NCT01996397

Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy

Exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-D reconstructions of lead movement, bioimpedance and VCG to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant. Pacing sites and contractility data will be compared to pre operative cardiac ultrasound and MRI metrics.

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Assessment of Acute CRT Response Bundle-Branch Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Resynchronization Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is indicated for CRT or CRT-D device according to current applicable ESC/AHA guidelines
  • Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). No documented AF-episodes allowed during the last 2 weeks prior to inclusion.
  • Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or ARB and Beta Blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
  • Subject (or the legal guardian) is willing to sign informed consent form

Exclusion criteria

  • Permanent atrial fibrillation/ flutter or tachycardia
  • RBBB
  • 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
  • Post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
  • Implanted with a left ventricular assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year
  • On chronic renal dialysis, or with 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)
  • On continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
  • Severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)
  • Complex and uncorrected congenital heart disease
  • Mechanical heart valve
  • Breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
  • Enrolled in one or more concurrent studies that would confound the results of this study
  • Already implanted with pacemaker (CRT, CRT-D, ICD) and needs replacement

Treatment and study plan

Cardiac resynchronization therapy device implantation

Procedure

Primary outcomes

  1. dP\dt max response to different ventricular lead pacing sites

    Time frame: 6 months

    To compare metrics derived from 2 or 3-D reconstructions of lead movement to augmentation of left ventricular contractility (LV dP/dt max) at different pacing configurations in patients undergoing a CRT-implant Main objective is to identify the optimal LV pacing site within each patient where the force of contraction during BiV pacing is maximized and to assess the feasibility of a non-invasive sensor to identify this optimal site.

Secondary outcomes

  1. Lead movements and electrical measures

    Time frame: 6 months

    Compare metrics derived from 2/3-D reconstructions of lead movement to electrical measures (e.g. Q-LV-timing or VCG) at different pacing configurations in patients undergoing a CRT-implant.

  2. Metrics derived from 2/3-D reconstructions of lead movement and Force-Interval-Relation

    Time frame: 6 months

    To compare metrics derived from 2/3-D reconstructions of lead movement to Force-Interval-Relation at different pacing configurations in patients undergoing a CRT-implant.

  3. Metrics derived from 2/3-D reconstructions of lead movement and CardioGuide Motion Map

    Time frame: 6 months

    To compare metrics derived from 2/3-D reconstructions of lead movement to CardioGuide Motion Map at different pacing configurations in patients undergoing a CRT-implant.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Registry information

Acronym: CCI impact

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2013
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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