AdaptResponse Clinical Study
- Conditions
- Heart Failure
- Registration Number
- JPRN-UMIN000015371
- Lead Sponsor
- Medtronic Japana Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 3800
Not provided
1,Subject is less than 18 years of age. 2,Subject is not expected to remain available for at least 2 years of follow-up visits. 3,Subject has permanent atrial arrhythmias for which pharmacological therapy and/or cardioversion have been unsuccessful or have not been attempted 4,Subject is, or previously has been, receiving CRT. 5,Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. 6,Subject has unstable angina, or experienced an acute myocardial infarction or received coronary artery revascularization or coronary angioplasty within 30 days prior to enrollment. 7,Subject has a mechanical tricuspid heart valve or is scheduled to undergo valve repair or valve replacement during the course of the study. 8,Subject is post heart transplant. 9,Subject has a limited life expectancy due to non-cardiac causes that would not allow completion of the study. 10,Subject is pregnant. 11,Subject meets any exclusion criteria required by local law.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of the combined endpoint of all-cause mortality and intervention for heart failure decompensation
- Secondary Outcome Measures
Name Time Method