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

NCT ID: NCT01996397

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-04-30

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.

Conditions

Heart Failure; Resynchronization Therapy; Assessment of Acute CRT Response

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CRT implantation

Standard CRT indication. Assessment of acute response to CRT.

Group Type: OTHER

Cardiac resynchronization therapy device implantation

Intervention Type: PROCEDURE

Interventions

Cardiac resynchronization therapy device implantation

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erik Kongsgaard

MD, Ph.d

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oslo University Hospital, Rikshospitalet

Oslo, Oslo County, Norway

Countries

Norway

References

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Related Links

http://www.heart-sfi.no/

Center for Cardiological Innovation

http://www.oslo-universitetssykehus.no

Oslo University Hospital

Other Identifiers

2013/140

Identifier Type: -

Identifier Source: org_study_id