N/A N=478 Randomized Double-blind Treatment

Adaptive Cardiac Resynchronization Therapy Study

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT00980057 ↗

Enrolled (actual)

478

Serious AEs

51.1%

Results posted

Oct 2018

Primary outcome: Primary: Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score — 234; 114 Participants — p=0.0002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Adaptive CRT (aCRT) (Device); Echo (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score	234; 114	0.0002 sig
PRIMARY Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings	0.93	<0.0001 sig
PRIMARY Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)	—	—
SECONDARY Right Ventricular Pacing Percentage	51.3; 95.1	<0.0001 sig
SECONDARY Change in Left Ventricular End Systolic Volume Index (LVESVi)	-8.3; -10.5	<0.0001 sig
SECONDARY Change in Left Ventricular Ejection Fraction (LVEF)	3.9; 2.9	0.0009 sig
SECONDARY Change in New York Heart Association (NYHA) Classification	-1.0; -0.8	<0.0001 sig
SECONDARY Change in Distance Walked During the Six Minute Hall Walk	42.4; 29.0	0.0002 sig
SECONDARY Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF)	-19.3; -17.6	0.002 sig

Summary

The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance

Eligibility Criteria

Inclusion Criteria

Subject is willing to sign and date the study Informed Consent form
Subject is at least 18 years of age (or older, if required by local law)
Subject is expected to remain available for at least six months of follow-up visits
Subject is indicated for a study device that will be implanted within 30 days after signing the Informed Consent form
Subject has an intrinsic QRS duration greater than or equal to 120 milliseconds (documented within 30 days prior to enrollment)
Subject has a left ventricular ejection fraction less than or equal to 35 percent (method per physician discretion) (documented within 180 days prior to enrollment)
Subject is diagnosed with New York Heart Association (NYHA) class III or IV (within 30 days prior to enrollment) despite optimal medical therapy which is defined as: ACE-inhibitor (Angiotensin-Converting Enzyme) or Angiotensin II Receptor Blocker (ARB), if tolerated, for at least one month prior to implant, AND beta-blocker for at least three months preceding implant, if tolerated, and stable for one month, OR subject has an urgent medical need for an implantable cardioverter defibrillator (ICD) that precludes waiting the one or three months for the medication requirements for ACE inhibitor, ARB or beta-blocker

Exclusion Criteria

Subject has chronic (permanent) atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted
Subject has existing CRT system
Subject has non-intact or unstable leads
Subject has medical conditions that would limit study participation (per physician discretion)
Subject is enrolled in one or more concurrent studies that would confound the study results of this study as determined by Medtronic
Subject has unstable angina, or experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) (documented within 30 days prior to enrollment)
Subject has a mechanical right heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study
Subject is post-heart transplant (subjects on the heart transplant list for the first time are not excluded)
Subject has a limited life expectancy that would not allow completion of the 6 month visit
Subject is pregnant (In the United States, all women of child-bearing potential must undergo a pregnancy test within seven days prior to aCRT download into device)
Subject meets the exclusion criteria required by local law

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00980057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.