NCT00980057: aCRT

Adaptive Cardiac Resynchronization Therapy Study

Completed NA Results posted Last updated 16 October 2018

What this trial tests

NA trial testing Adaptive CRT (aCRT) in Heart Failure in 522 participants. Completed in 8 March 2012.

Timeline

1 October 2009

Primary endpoint
4 August 2011

8 March 2012

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	522
Start date	1 October 2009
Primary completion	4 August 2011
Estimated completion	8 March 2012
Sites	105 locations across Hong Kong, Italy, Japan, Denmark, Netherlands, Russia, Belgium, Sweden

Drugs / interventions tested

• Adaptive CRT (aCRT)
• Echo

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

18 and older, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients With Improved Heart Failure Outcomes Clinical Composite Score Primary · randomization to six month visit

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

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	234
Standard Biventricular Pacing	114

Correlation Between Aortic Velocity Time Integral (AoVTI) at Adaptive CRT and Echo-optimized Device Settings Primary · randomization visit and six month visit

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.

Group	Value	95% CI
All Randomized Patients	0.93	0.91 – 0.94

Percentage of Patients With a Safety Event (Inappropriate AV or VV Delay Settings Related to the aCRT Feature) Primary · randomization to 6 months post randomization

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)

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	0

Right Ventricular Pacing Percentage Secondary · implant to six months post randomization

The percentage of time the right ventricle is paced by the device

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	51.3	± 37.9
Standard Biventricular Pacing	95.1	± 10.5

Change in Left Ventricular End Systolic Volume Index (LVESVi) Secondary · baseline to six month visit

Change in left ventricular end systolic volume index (LVESVi).

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	-8.3	± 23.3
Standard Biventricular Pacing	-10.5	± 24.2

Change in Left Ventricular Ejection Fraction (LVEF) Secondary · baseline to six month visit

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	3.9	± 10.0
Standard Biventricular Pacing	2.9	± 9.8

Change in New York Heart Association (NYHA) Classification Secondary · baseline to six month visit

The New York Heart Association (NYHA) Functional Classification places patients in one of four categories based on how much they are limited during physical activity. Class - Patient Symptoms I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). II- Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). III- Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	-1.0	± 0.8
Standard Biventricular Pacing	-0.8	± 0.8

Change in Distance Walked During the Six Minute Hall Walk Secondary · baseline to six month visit

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	42.4	± 103.3
Standard Biventricular Pacing	29.0	± 123.0

Change in Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire (MLWHF) Secondary · baseline to six month visit

The MLWHF is a 21 question survey. Scores range from 0-105, with lower scores indicating better health.

Group	Value	95% CI
Adaptive CRT (aCRT) Pacing	-19.3	± 20.7
Standard Biventricular Pacing	-17.6	± 23.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From randomization to the end of the study, which was 31.3 months for the longest-randomized patient. The average follow-up time was 20.2 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adaptive CRT (aCRT) Pacing

Serious: 158/318 (50%)

Deaths: 35/318

Standard Biventricular Pacing

Serious: 86/160 (54%)

Deaths: 19/160

Serious adverse events (206 terms)

Reaction	System	Adaptive CRT (aCRT) Pacing	Standard Biventricular Pac…
Cardiac failure	Cardiac disorders	—	—
Pneumonia	Infections and infestations	—	—
Device dislocation	General disorders	—	—
Ventricular tachycardia	Cardiac disorders	—	—
Renal failure acute	Renal and urinary disorders	—	—
Coronary artery disease	Cardiac disorders	—	—
Sepsis	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Chest pain	General disorders	—	—
Renal failure	Renal and urinary disorders	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Atrial flutter	Cardiac disorders	—	—
Cardiac arrest	Cardiac disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Bronchitis	Infections and infestations	—	—
Implant site infection	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Orthostatic hypotension	Vascular disorders	—	—
Angina pectoris	Cardiac disorders	—	—
Intracardiac thrombus	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Cellulitis	Infections and infestations	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Adaptive CRT (aCRT) Pacing	Standard Biventricular Pac…
Cardiac failure	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Device stimulation issue	General disorders	—	—

Most-reported serious reactions: Cardiac failure, Pneumonia, Device dislocation, Ventricular tachycardia, Renal failure acute, Coronary artery disease, Sepsis, Anaemia.

Data from ClinicalTrials.gov NCT00980057 adverse events section.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of a Novel Adaptive Optimization Algorithm on 30-Day Readmissions: Evidence From the Adaptive CRT Trial.
   Starling RC, Krum H, Bril S, Tsintzos SI, et al · · 2015 · cited 41× · PMID 26071616 · DOI 10.1016/j.jchf.2015.03.001
2. Adaptive CRT in patients with normal AV conduction and left bundle branch block: Does QRS duration matter?
   Yamasaki H, Lustgarten D, Cerkvenik J, Birnie D, et al · · 2017 · cited 13× · PMID 28416247 · DOI 10.1016/j.ijcard.2017.04.036
3. Characterization of medical device randomized controlled trials with adaptive designs.
   Su G, Shen D, Deng D, Bai Q, et al · · 2025 · cited 1× · PMID 39656083 · DOI 10.57264/cer-2024-0011