Acute Feedback on Left ventrIcular Lead Implantation Location for Cardiac Resynchronization Therapy (CCI impact)
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|ClinicalTrials.gov Identifier: NCT01996397|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : March 31, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Resynchronization Therapy Assessment of Acute CRT Response||Procedure: Cardiac resynchronization therapy device implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|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|
Standard CRT indication. Assessment of acute response to CRT.
Procedure: Cardiac resynchronization therapy device implantation
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Permanent atrial fibrillation/ flutter or tachycardia
- 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
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
|Oslo University Hospital, Rikshospitalet|
|Oslo, Norway, 0424|
|Responsible Party:||Erik Kongsgaard, MD, Ph.d, Oslo University Hospital|
|Other Study ID Numbers:||
|First Posted:||November 27, 2013 Key Record Dates|
|Last Update Posted:||March 31, 2016|
|Last Verified:||March 2016|
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