BridgeMD
Tests treatment safety and results for Atrial Fibrillation (AF)
Official title Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06883864
What this study is testing
What is Medication?
Medication is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for atrial fibrillation (af).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients were required to have moderate-to-severe or greater (≥3+) atrial functional mitral regurgitation assessed by transthoracic echocardiography...
- Age 18-80 years
- Persistent atrial fibrillation diagnosed by electrocardiogram
- Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the...
- Left ventricular end-diastolic internal diameter ≤60 mm and left atrial anterior- posterior diameter ≤60 mm in echocardiographic parasternal...
You likely can't join if
- paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;
- primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective...
- history of previous mitral valve surgery or transcatheter manipulation;
- mitral valve orifice area \<4 cm2;
- aortic valve disease requiring surgical or transcatheter intervention;
- untreated clinically significant coronary artery disease requiring revascularization;
See the full eligibility criteria
- Patients were required to have moderate-to-severe or greater (≥3+) atrial functional mitral regurgitation assessed by transthoracic echocardiography within 14 days before randomization. Mitral regurgitation severity was...
- Age 18-80 years
- Persistent atrial fibrillation diagnosed by electrocardiogram
- Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the echocardiography core-lab)
- Left ventricular end-diastolic internal diameter ≤60 mm and left atrial anterior- posterior diameter ≤60 mm in echocardiographic parasternal long-axis view within 14 days before randomization(confirmed by the...
- Agree to undergo catheter ablation and be able to undergo follow-up as required.
- paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;
- primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective endocarditis, rheumatic lesions, or ischemic lesions;
- history of previous mitral valve surgery or transcatheter manipulation;
- mitral valve orifice area \<4 cm2;
- aortic valve disease requiring surgical or transcatheter intervention;
- untreated clinically significant coronary artery disease requiring revascularization;
- history of previous myocardial infarction;
- previous definitive diagnosis of cardiomyopathies such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, arrhythmogenic cardiomyopathy, and infiltrative...
- echocardiographic evidence of intracardiac mass or thrombus;
- implant of cardiac device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or left atria appendage closure);
- hemodynamic instability requiring cardiac assist devices, intra-aortic balloon pump (IABP), or other hemodynamic support;
- any percutaneous cardiac intervention (percutaneous coronary intervention, transcatheter aortic valve replacement, etc.) within the 30 days prior to randomization,
- any cardiac surgery within the 6 months prior to randomization;
- active infections requiring current antibiotic therapy;
- a known hypersensitivity or contradiction to procedure medications which cannot be adequately managed medically;
- contraindication to appropriate anti-coagulation therapy;
- chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic oral steroid therapy;
- acute cerebrovascular accident within 30 days prior to randomization or Modified Rankin Score ≥ 4;
- symptomatic severe carotid stenosis (\>70% by ultrasound);
- other planned surgical or treatment procedures within the next 3 months;
- liver failure;
- renal failure or dialysis status;
- pregnant or planning pregnancy within the next 3 months;
- life expectancy \< 12 months (e.g., advanced malignant tumors);
- currently participating in other treatment studies;
- circumstances that, in the judgment of the researcher, make participation in this study unsuitable.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changchun, Jilin, China
- Yinchuan, Ningxia, China
- Jinan, Shandong, China
- Xi’an, Shanxi, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Harbin, Heilongjiang, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.