Atrial fibrillation (AF) leads to atrial functional mitral regurgitation (MR) through mechanisms including mitral annular dilatation, systolic leaflet motion distance alteration, and contractility decrease. Compared with primary MR, atrial functional MR due to AF and other diseases tends to have a worse prognosis, with a higher risk of death and heart failure hospitalization. MR and AF co-exist and exacerbate left atrial dysfunction, further causing worse cardiac dysfunction, valvular regurgitation, and aggravating prognosis. The best therapy for secondary MR is unclear because MR is only one component of the disease, and restoration of mitral valve competence is not curative. Catheter ablation improves symptoms and cardiac function in patients with AF, reduces risks of AF recurrence and hospitalization, as well as increases quality of life. For patients with AF combined with functional moderate-to-severe MR, previous observational studies have found that the severity of MR significantly reduced after taking catheter ablation to restore sinus rhythm. We hypothesized that catheter ablation would significantly improve the severity of MR in patients with severe atrial functional MR combined with persistent AF compared with drug therapy alone.
The ELEVATE-AF is a multi-center, open-label, parallel design, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to the catheter ablation combined with drug group or to the drug-alone group. A total of 146 patients with persistent atrial fibrillation and severe atrial functional mitral regurgitation (MR) (severity of moderate-to-severe \[3+\] or severe \[4+\]) will be enrolled at up to 17 investigational sites in China. The enrollment period is estimated to last approximately 18 months. The primary endpoint is the proportion of patients with residual MR of moderate \[2+\] or less assessed by transthoracic echocardiography at 3 months. MR severity is confirmed by the Echocardiography Core Lab according to the American Society of Cardiac Ultrasound criteria (mitral effective regurgitant orifice area \[EROA)\]≤20 mm2). The secondary endpoints evaluate: (i)all-cause mortality; (ii)cardiovascular hospitalization; (iii)undergoing interventional or surgical treatment of mitral valve; (iv)heart failure hospitalization or emergency room visit; (v)change in scores on the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire, and the 5-level EQ-5D version (EQ-5D-5L); (vi) freedom from any documented atrial arrhythmias lasting more than 30 seconds and atrial fibrillation burden. The safety endpoints include: (i)perioperative surgical complications (within 30 days after catheter ablation procedure); (ii)major bleeding (ISTH definition); (iii)stroke and systemic embolism. As an extension of the ELEVATE-AF trial, ELEVATE-AF X study will conducted after 3-month follow-up of ELEVATE-AF. The ELEVATE-AF X study is designed as a prospective, multi-center, continued access registry study. The objective of the this study is to validate the long-term outcomes of catheter ablation procedure in patients with persistent AF and severe atrial functional MR. All patients will receive catheter ablation if the procedure is needed, and the medical therapy for ELEVATE-AF X is identical to that of ELEVATE-AF trial. Active follow-up of patients will be performed through 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
All patients will receive atrial fibrillation catheter ablation. They also should receive guideline-directed medical therapy, anticoagulation, and rate control with medications according to the guidelines.
Patients will receive guideline-directed medical therapy, anticoagulation, and rate control according to the guidelines for the management of AF and heart failure.
Subsequent ablations may be considered for patients with recurrence,and the medical therapy for ELEVATE-AF X is identical to that of the ELEVATE-AF trial.
All patients could receive catheter ablation if the procedure is needed, and the medical therapy for ELEVATE-AF X is identical to that of the ELEVATE-AF trial.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months.
The primary endpoint is the proportion of patients with residual MR of moderate \[2+\] or less assessed by transthoracic echocardiography at 3 months. MR severity is confirmed by the Echocardiography Core Lab according to the American Society of Cardiac Ultrasound criteria (mitral effective regurgitant orifice area \[EROA)\]≤20 mm2).
Time frame: 3 month
all-cause mortality
Time frame: 3 month
cardiovascular hospitalization
Time frame: 3 month
undergoing interventional or surgical treatment of mitral valve
Time frame: 3 month
heart failure hospitalization or emergency room visit
Time frame: 3 month
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score change between baseline and 3 month
Quality of life assessed by AFEQT questionaire
Time frame: 3 month
EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score change between baseline and 3 month
Quality of life assessed by EQ-5D-5L scale
Time frame: 3 month
freedom from any documented atrial arrhythmias lasting more than 30 seconds and atrial fibrillation burden
Time frame: 3 month
(ELEVATE-AF X) the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography
Time frame: 12 month
(ELEVATE-AF X) all-cause mortality
Time frame: 12 month
(ELEVATE-AF X) cardiovascular hospitalization
Time frame: 12 month
(ELEVATE-AF X) undergoing interventional or surgical treatment of mitral valve
Time frame: 12 month
(ELEVATE-AF X) heart failure hospitalization or emergency room visit
Time frame: 12 month
(ELEVATE-AF X) Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score change between baseline and 12 month
Quality of life assessed by AFEQT questionaire
Time frame: 12 month
(ELEVATE-AF X) EuroQoL 5-Dimension 5-Level (EQ-5D-5L) score change between baseline and 12 month
Quality of life assessed by EQ-5D-5L scale
Time frame: 12 month
(ELEVATE-AF X) freedom from any documented atrial arrhythmias lasting more than 30 seconds and atrial fibrillation burden
Time frame: 12 month
Caihua Sang, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.