AdaptResponse Version 1.0
Research type
Research Study
Full title
AdaptResponse
IRAS ID
164099
Contact name
Archana Rao
Contact email
Sponsor organisation
Medtronic, Bakken Research Centre B.V.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
MDT2151540, Medtronic Internal
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Summary of Research
Heart Failure (HF) is a serious condition in which the heart does not pump blood around the body effectively. Each year, HF is associated with more than one million admissions to hospital and, on average after the first admission, a patient will experience a further 1.3 admissions for HF during the following twelve months.
Cardiac Resynchronisation Therapy (CRT) is an established HF treatment which manages heart function using controlled electrical impluses delivered via an electronic device typically implanted under the skin of the chest. Whilst CRT is effective, up to a third of patients do not experience the full benefits of the treatment. The reasons for this are multifactorial, however patient-specific characteristics which necessitate adjustments to the device settings could be one of them. Historically, such adjustments could only be made periodically at clinic visits with settings being fixed until subsequent visits, regardless of any interim needs.
In order to address this issue, the study sponsor, Medtronic, has developed a feature within the device which is capable of automatically adapting therapy on a regular basis without the need to attend hospital. This feature is known as AdaptivCRT (aCRT®).
This study will examine the effectiveness of the aCRT® feature in certain patients identified as requiring CRT as part of their clinical care. Market-released Medtronic CRT devices containing the aCRT® feature are to be implanted under standard procedures, effectiveness being assessed by comparing outcomes in patients for whom the aCRT® feature is switched “ON” with those in whom it is “OFF”.
It is expected that 3000 patients globally will take part, each of whom will be followed at 6 monthly intervals for an anticipated 5.5 years. Clinic visits will take place at 3 months, 6 months and every 6 months thereafter until study closure.Sumary of Results
Medtronic was the sponsor of the AdaptResponse study which took place from August 2014-November 2022.
The AdaptResponse trial included 3797 patients who needed cardiac resynchronisation therapy (CRT) for their heart failure and who had two specific characteristics on their ECG. The CRT device contains the adaptive CRT feature, which monitors and automatically optimizes the pacing method of the CRT device depending on your own heart rhythm. Of the 3797 patients included, 3617 participants were randomly assigned to get either adaptive CRT using Medtronic’s AdaptivCRT feature (N=1810) or conventional CRT (N=1807). The participants were from 227 centers in 27 countries. The average age of the study patients was 64.9 years and 43.4% were female. The goal of this study was to examine the effectiveness of the AdaptivCRT® algorithm in certain patients identified as requiring cardiac resynchronization therapy (CRT) for their heart failure as part of their regular clinical care.
The study showed that patients with a CRT in which the AdaptiveCRT feature was switched on did a bit better than those with a CRT with the feature switched off, however, this difference was not statistically significant, which means that the difference is too small to confirm the feature gives better results. Importantly, participants in both groups experienced lower mortality, less worsening heart failure and a higher response to therapy than seen in earlier CRT studies. This indicates that CRT has a greater benefit in this specific subgroup of heart failure patients than previously thought. Additionally, device battery life was higher with adaptive CRT than with normal CRT. Of all heart failure studies up to today, in the AdaptResponse study participated the most women, both in number (1569) and percentage (43%). It is very important that information has become available about the effect of CRT therapy in women because women and men may react in different ways to a similar treatment.
Results of the study can be found on ClinicalTrials.gov or in the main paper: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbaNKhM2veQCpNbb8U3lc6HRWLXRdGsWGE29hfJMiGqHyxnSCCviqmx0G-2BexJ1JDZGQ-3D-3DNP28_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIvwjk9eoRmReF0-2FhDusb7EARQKSI0cFEe9S9jfs2ONEIWWoHUpzBwKTXjhINsYT-2B10chn0e9CXqbJp8R1zSK2BYw4bIrxBbmSNm7Bl6RYiJbYRWkp-2B55yGnlTZz-2BieER2dz39NsyUSWSH2IjtXv-2BHOlntYB618-2B5LwLQB-2BaLHQwA-3D-3D&data=05%7C01%7Cgmsouth.rec%40hra.nhs.uk%7C78fcae12837d4eadbad708dbbff3bcd1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638314825782491187%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=xzraas3a%2F4XTJWoL0PFyC5TFMnQjKrQAa4WV4v%2FGPrI%3D&reserved=0REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0142
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion