The AdaptResponse clinical study

Recruiting

• Conditions: heart decompensation; Heartfailure; 10019280

• Registration Number: NL-OMON53104
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

* Subject is indicated for a CRT device according to local guidelines.
* Subject has, minimally:
o Sinus Rhythm at time of enrollment.
o Left Bundle Branch Block (LBBB)
o Intrinsic, normal AV conduction
o Left ventricular ejection fraction less than or equal to 35%
o NYHA class II, III or IV

Exclusion Criteria

* Subject is not expected to remain available for at least 2 years of follow-up
visits.
* Subject has permanent atrial arrhythmias for which pharmacological therapy
and/or
cardioversion have been unsuccessful or have not been attempted
* Subject is, or previously has been, receiving CRT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To test the hypothesis that AdaptivCRT® reduces the incidence of the combined<br /><br>endpoint of all-cause mortality and intervention for heart failure<br /><br>decompensation, compared to standard CRT therapy, in patients with a CRT<br /><br>indication, LBBB and normal AV conduction. Intervention for heart failure<br /><br>decompensation (HF event) is defined as an event requiring *invasive<br /><br>intervention (i.e. IV diuretics, ultrafiltration, or equivalent)* or inpatient<br /><br>hospitalization*.</p><br>