Adaptive Cardiac Resynchronization Therapy Study

NCT00980057 | Completed Results

• 1 other identifier: Adaptive CRT
• Study Type: interventional
• Target: 522
• Locations: 17 countries
• Sites: 101

Brief 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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score

  Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse on 'patient global assessment' compared to before CRT implant. Patients are improved if they are not worsened and have an improved NYHA or reported moderately/markedly improved on the 'patient global assessment' compared to before CRT implant Global assessment question for the patient: Specifically in reference to your heart failure symptoms, how do you feel today as compared to how you felt before your CRT system was implanted? O Markedly improved O Moderately improved O Mildly improved O No change O Slightly worse O Moderately worse O Markedly worse

  randomization to six month visit

• Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings

  Correlation between aortic velocity time integral (AoVTI) at Adaptive CRT and echo-optimized device settings. AoVTI is an echocardiographic representative of stroke volume and cardiac performance.

  randomization visit and six month visit

• Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature)

  For each subject, the Adaptive CRT-determined AV and VV delay settings from randomization up to 183-days post-randomization were evaluated to identify any period of 28-days with a wide delay range (\>60 ms)

  randomization to 6 months post randomization

Secondary Outcomes (6)

• Right Ventricular Pacing Percentage

  implant to six months post randomization

• Change in Left Ventricular End Systolic Volume Index (LVESVi)

  baseline to six month visit

• Change in Left Ventricular Ejection Fraction (LVEF)

  baseline to six month visit

• Change in New York Heart Association (NYHA) Classification

  baseline to six month visit

• Change in Distance Walked During the Six Minute Hall Walk

  baseline to six month visit

Study Arms (2)

Adaptive CRT (aCRT) arm

EXPERIMENTAL

Intervention: Cardiac resynchronization therapy (CRT-D) with Adaptive CRT algorithm ON

Device: Adaptive CRT (aCRT)

Echo-optimized arm

ACTIVE COMPARATOR

Intervention: Cardiac resynchronization therapy (CRT-D) with standard biventricular pacing (Adaptive CRT algorithm OFF)

Device: Echo

Interventions

Adaptive CRT (aCRT) DEVICE

Adaptive CRT (aCRT) is an algorithm, which provides ambulatory adjustment of pacing configuration (LV-only or BiV) and AV and VV delays based on periodic automatic evaluation of electrical conduction to optimize cardiac function

Also known as: aCRT

Adaptive CRT (aCRT) arm

Echo DEVICE

Standard BiV pacing with settings optimized using a standardized echocardiographic protocol

Also known as: Control

Echo-optimized arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (105)

Unknown Facility

Huntsville, Alabama, 36264, United States

Location

Unknown Facility

Anchorage, Alaska, 36264, United States

Location

Unknown Facility

Phoenix, Arizona, 36264, United States

Location

Unknown Facility

Little Rock, Arkansas, 36264, United States

Location

Unknown Facility

Glendale, California, 36264, United States

Location

Unknown Facility

San Bernardino, California, 36264, United States

Location

Unknown Facility

San Diego, California, 36264, United States

Location

Unknown Facility

Colorado Springs, Colorado, 36264, United States

Location

Unknown Facility

Denver, Colorado, 36264, United States

Location

Unknown Facility

Clearwater, Florida, 36264, United States

Location

Unknown Facility

Jacksonville, Florida, 36264, United States

Location

Unknown Facility

Orlando, Florida, 36264, United States

Location

Unknown Facility

Pensacola, Florida, 36264, United States

Location

Unknown Facility

Augusta, Georgia, 36264, United States

Location

Unknown Facility

Barrington, Illinois, 36264, United States

Location

Unknown Facility

Fort Wayne, Indiana, 36264, United States

Location

Unknown Facility

Davenport, Iowa, 36264, United States

Location

Unknown Facility

Des Moines, Iowa, 36264, United States

Location

Unknown Facility

Kansas City, Kansas, 36264, United States

Location

Unknown Facility

Louisville, Kentucky, 36264, United States

Location

Unknown Facility

Takoma Park, Maryland, 36264, United States

Location

Unknown Facility

Burlington, Massachusetts, 36264, United States

Location

Unknown Facility

Detroit, Michigan, 36264, United States

Location

Unknown Facility

Grand Rapids, Michigan, 36264, United States

Location

Unknown Facility

Saginaw, Michigan, 36264, United States

Location

Unknown Facility

Saint Cloud, Minnesota, 36264, United States

Location

Unknown Facility

Saint Louis Park, Minnesota, 36264, United States

Location

Unknown Facility

Saint Paul, Minnesota, 36264, United States

Location

Unknown Facility

Tupelo, Mississippi, 36264, United States

Location

Unknown Facility

Kansas City, Missouri, 36264, United States

Location

Unknown Facility

St Louis, Missouri, 36264, United States

Location

Unknown Facility

Lincoln, Nebraska, 36264, United States

Location

Unknown Facility

Morristown, New Jersey, 36264, United States

Location

Unknown Facility

Brooklyn, New York, 36264, United States

Location

Unknown Facility

Buffalo, New York, 36264, United States

Location

Unknown Facility

New York, New York, 36264, United States

Location

Unknown Facility

Charlotte, North Carolina, 36264, United States

Location

Unknown Facility

Greensboro, North Carolina, 36264, United States

Location

Unknown Facility

Cleveland, Ohio, 36264, United States

Location

Unknown Facility

Columbus, Ohio, 36264, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 36264, United States

Location

Unknown Facility

Portland, Oregon, 36264, United States

Location

Unknown Facility

Charleston, South Carolina, 36264, United States

Location

Unknown Facility

Spartanburg, South Carolina, 36264, United States

Location

Unknown Facility

Chattanooga, Tennessee, 36264, United States

Location

Unknown Facility

Austin, Texas, 36264, United States

Location

Unknown Facility

Dallas, Texas, 36264, United States

Location

Unknown Facility

Tyler, Texas, 36264, United States

Location

Unknown Facility

Burlington, Vermont, 36264, United States

Location

Unknown Facility

Norfolk, Virginia, 36264, United States

Location

Unknown Facility

Richmond, Virginia, 36264, United States

Location

Unknown Facility

Bellingham, Washington, 36264, United States

Location

Unknown Facility

Spokane, Washington, 36264, United States

Location

Unknown Facility

Morgantown, West Virginia, 36264, United States

Location

Unknown Facility

Milwaukee, Wisconsin, 36264, United States

Location

Unknown Facility

Adelaide, Australia

Location

Unknown Facility

Camperdown, Australia

Location

Unknown Facility

Chermside, Australia

Location

Unknown Facility

Darlinghurst, Australia

Location

Unknown Facility

Perth, Australia

Location

Unknown Facility

Spring Hill, Australia

Location

Unknown Facility

Linz, Austria

Location

Unknown Facility

Genk, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Yvoir, Belgium

Location

Unknown Facility

Calgary, Canada

Location

Unknown Facility

London, Canada

Location

Unknown Facility

Montreal, Canada

Location

Unknown Facility

Newmarket, Canada

Location

Unknown Facility

Ottawa, Canada

Location

Unknown Facility

Victoria, Canada

Location

Unknown Facility

Aalborg, Denmark

Location

Unknown Facility

Aarhus, Denmark

Location

Unknown Facility

Copenhagen, Denmark

Location

Unknown Facility

Odense, Denmark

Location

Unknown Facility

Bochum, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Lüdenscheid, Germany

Location

Unknown Facility

Reinbek, Germany

Location

Unknown Facility

Trier, Germany

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Pedara, Italy

Location

Unknown Facility

Rozzano, Italy

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Tsukuba, Japan

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Bergen, Norway

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Tyumen, Russia

Location

Unknown Facility

Riyadh, Saudi Arabia

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Kamenitz, Serbia

Location

Unknown Facility

Niš, Serbia

Location

Unknown Facility

Albacete, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Majadahonda, Spain

Location

Unknown Facility

Vitoria-Gasteiz, Spain

Location

Unknown Facility

Lund, Sweden

Location

Unknown Facility

Stockholm, Sweden

Location

Related Publications (6)

• Gasparini M, Birnie D, Lemke B, Aonuma K, Lee KL, Gorcsan J 3rd, Landolina M, Klepfer R, Meloni S, Cicconelli M, Grammatico A, Martin DO. Adaptive Cardiac Resynchronization Therapy Reduces Atrial Fibrillation Incidence in Heart Failure Patients With Prolonged AV Conduction: The Adaptive CRT Randomized Trial. Circ Arrhythm Electrophysiol. 2019 May;12(5):e007260. doi: 10.1161/CIRCEP.119.007260. No abstract available.

  PMID: 30991823 DERIVED

• Birnie D, Hudnall H, Lemke B, Aonuma K, Lee KL, Gasparini M, Gorcsan J 3rd, Cerkvenik J, Martin DO. Continuous optimization of cardiac resynchronization therapy reduces atrial fibrillation in heart failure patients: Results of the Adaptive Cardiac Resynchronization Therapy Trial. Heart Rhythm. 2017 Dec;14(12):1820-1825. doi: 10.1016/j.hrthm.2017.08.017. Epub 2017 Sep 9.

  PMID: 28893549 DERIVED

• Yamasaki H, Lustgarten D, Cerkvenik J, Birnie D, Gasparini M, Lee KL, Sekiguchi Y, Varma N, Lemke B, Starling RC, Aonuma K. Adaptive CRT in patients with normal AV conduction and left bundle branch block: Does QRS duration matter? Int J Cardiol. 2017 Aug 1;240:297-301. doi: 10.1016/j.ijcard.2017.04.036. Epub 2017 Apr 12.

  PMID: 28416247 DERIVED

• Starling RC, Krum H, Bril S, Tsintzos SI, Rogers T, Hudnall JH, Martin DO. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial. JACC Heart Fail. 2015 Jul;3(7):565-572. doi: 10.1016/j.jchf.2015.03.001. Epub 2015 Jun 10.

  PMID: 26071616 DERIVED

• Birnie D, Lemke B, Aonuma K, Krum H, Lee KL, Gasparini M, Starling RC, Milasinovic G, Gorcsan J 3rd, Houmsse M, Abeyratne A, Sambelashvili A, Martin DO. Clinical outcomes with synchronized left ventricular pacing: analysis of the adaptive CRT trial. Heart Rhythm. 2013 Sep;10(9):1368-74. doi: 10.1016/j.hrthm.2013.07.007. Epub 2013 Jul 11.

  PMID: 23851059 DERIVED

• Krum H, Lemke B, Birnie D, Lee KL, Aonuma K, Starling RC, Gasparini M, Gorcsan J, Rogers T, Sambelashvili A, Kalmes A, Martin D. A novel algorithm for individualized cardiac resynchronization therapy: rationale and design of the adaptive cardiac resynchronization therapy trial. Am Heart J. 2012 May;163(5):747-752.e1. doi: 10.1016/j.ahj.2012.02.007.

  PMID: 22607850 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Adaptive CRT Clinical Research Specialist
• Organization: Medtronic, Inc

medtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• Adaptive CRT Trial Leader

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: October 1, 2009
• Primary Completion: August 4, 2011
• Study Completion: March 8, 2012
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-09

Locations

NO (2); GR (1); JP (3); SA (1); HU (1); BE (3); RU (1); DE (5); NL (2); US (55); AU (6); CA (6); DK (4); HK (1); SE (2); IT (4); ES (4)