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Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy (CCI impact)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01996397
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Erik Kongsgaard, Oslo University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Resynchronization Therapy Assessment of Acute CRT Response Procedure: Cardiac resynchronization therapy device implantation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy
Study Start Date : May 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
CRT implantation
Standard CRT indication. Assessment of acute response to CRT.
 Procedure: Cardiac resynchronization therapy device implantation


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996397


Locations
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Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Medtronic Bakken Research Center
More Information
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Additional Information:

Publications:

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Responsible Party: Erik Kongsgaard, MD, Ph.d, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01996397    
Other Study ID Numbers: 2013/140
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Keywords provided by Erik Kongsgaard, Oslo University Hospital:
Heart failure
Bundle branch block
CRT response
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases