[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580118":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":44,"locations":50,"responsibleParty":237,"collaborators":239,"id":245,"slug":246,"hasResults":247,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":247,"sex":253,"minAge":254,"maxAge":20,"enrollmentInfo":255,"targetDuration":20,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":215,"whyStopped":20,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},{"fullName":5,"class":6},"French Cardiology Society","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group with pacemaker implantation and atrioventricular node ablation","EXPERIMENTAL","Pacemaker implantation and atrioventricular node ablation will be performed within a one week period after the randomization.Pharmacological heart failure therapy will be optimized according to current guidelines.",[13,14,15],"Procedure: pacemaker implantation","Procedure: atrioventricular node ablation","Device: Pacemaker programming",{"label":17,"type":18,"description":19,"interventionNames":20},"Control","NO_INTERVENTION","Conventional care support. The rate control therapy will be optimized to achieve a resting heart rate of \\\u003C110 beats per minute. Pharmacological heart failure therapy will be optimized according to current guidelines.",null,[22,27,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"PROCEDURE","pacemaker implantation","The Medtronic 3830 lead should be used as the Conduction System Pacing lead. However, in case of unsuccessful implantation with the 3830 lead, a stylet-driven lead can be used as an alternative.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":20},"atrioventricular node ablation","Right-sided atrioventricular junction ablation will be attempted first with a radiofrequency catheter. The choice of the catheter will be at the discretion of the physician. The catheter will be advanced to the His Bundle and then slightly withdrawn proximally and caudally in order to target the compact atrioventricular node. Repeated ablation procedures will be recommended during follow-up if regression of atrioventricular block occurs.",[9],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":20},"DEVICE","Pacemaker programming","The pacemaker device will be programmed in VVIR mode at a lower rate of 75 beats per minute in bipolar mode for sensing and pacing",[9],[37,41],{"name":38,"affiliation":39,"role":40},"Frédéric ANSELME, MD","CHU de Rouen, France","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":39,"role":43},"Corentin CHAUMONT, MD","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":20,"email":49},"Tessa BERGOT, MSc","CONTACT","+33144907033","tessa.bergot@sfcardio.fr",[51,67,79,91,105,117,129,141,153,165,177,189,201,213,226],{"facility":52,"status":53,"city":54,"state":20,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"OLV Aalst","NOT_YET_RECRUITING","Aalst","9300","Belgium","BE",{"type":59,"coordinates":60},"Point",[61,62],4.0355,50.93604,{"lat":62,"lon":61},[65],{"name":66,"role":47,"phone":20,"phoneExt":20,"email":20},"Ward HEGGERMONT, MD",{"facility":68,"status":53,"city":69,"state":20,"zip":70,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"UZ Leuven","Leuven","3000",{"type":59,"coordinates":72},[73,74],4.70093,50.87959,{"lat":74,"lon":73},[77],{"name":78,"role":47,"phone":20,"phoneExt":20,"email":20},"Gabor VOROS, MD",{"facility":80,"status":53,"city":81,"state":20,"zip":82,"country":56,"countryCode":57,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Clinique St Pierre Ottignies","Ottignies-Louvain-la-Neuve","1340",{"type":59,"coordinates":84},[85,86],4.55023,50.66714,{"lat":86,"lon":85},[89],{"name":90,"role":47,"phone":20,"phoneExt":20,"email":20},"Aurélien WAUTERS, MD",{"facility":92,"status":53,"city":93,"state":20,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"CHRU de Brest - Hôpital de la Cavale Blanche","Brest","29200","France","FR",{"type":59,"coordinates":98},[99,100],-4.48628,48.39029,{"lat":100,"lon":99},[103],{"name":104,"role":47,"phone":20,"phoneExt":20,"email":20},"Jacques MANSOURATI, MD",{"facility":106,"status":53,"city":107,"state":20,"zip":108,"country":95,"countryCode":96,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"CHRU de Caen","Caen","14000",{"type":59,"coordinates":110},[111,112],-0.35912,49.18585,{"lat":112,"lon":111},[115],{"name":116,"role":47,"phone":20,"phoneExt":20,"email":20},"Pierre OLLITRAULT, MD",{"facility":118,"status":53,"city":119,"state":20,"zip":120,"country":95,"countryCode":96,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"CHRU de Tours - Trousseau","Chambray-lès-Tours","37170",{"type":59,"coordinates":122},[123,124],0.70286,47.33537,{"lat":124,"lon":123},[127],{"name":128,"role":47,"phone":20,"phoneExt":20,"email":20},"Arnaud BISSON, MD",{"facility":130,"status":53,"city":131,"state":20,"zip":132,"country":95,"countryCode":96,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"CHU Grenoble Alpes","Grenoble","38043",{"type":59,"coordinates":134},[135,136],5.71479,45.17869,{"lat":136,"lon":135},[139],{"name":140,"role":47,"phone":20,"phoneExt":20,"email":20},"Pascal DEFAYE, MD",{"facility":142,"status":53,"city":143,"state":20,"zip":144,"country":95,"countryCode":96,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Groupe Hospitalier La Rochelle-Ré-Aunis","La Rochelle","17019",{"type":59,"coordinates":146},[147,148],-1.15222,46.16308,{"lat":148,"lon":147},[151],{"name":152,"role":47,"phone":20,"phoneExt":20,"email":20},"Antoine MILHEM, MD",{"facility":154,"status":53,"city":155,"state":20,"zip":156,"country":95,"countryCode":96,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"CHRU Lille","Lille","59000",{"type":59,"coordinates":158},[159,160],3.05512,50.63391,{"lat":160,"lon":159},[163],{"name":164,"role":47,"phone":20,"phoneExt":20,"email":20},"Christelle MARQUIE, MD",{"facility":166,"status":53,"city":167,"state":20,"zip":168,"country":95,"countryCode":96,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"GHICL Allome - Hôpital St Philibert","Lomme","59462",{"type":59,"coordinates":170},[171,172],2.98715,50.64358,{"lat":172,"lon":171},[175],{"name":176,"role":47,"phone":20,"phoneExt":20,"email":20},"Guillaume VIART, MD",{"facility":178,"status":53,"city":179,"state":20,"zip":180,"country":95,"countryCode":96,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Clinique Millenaire","Montpellier","34000",{"type":59,"coordinates":182},[183,184],3.87635,43.61093,{"lat":184,"lon":183},[187],{"name":188,"role":47,"phone":20,"phoneExt":20,"email":20},"Nicolas CLEMENTY, MD",{"facility":190,"status":53,"city":191,"state":20,"zip":192,"country":95,"countryCode":96,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"CHU de Nantes - Hôpital Nord Laennec","Nantes","44093",{"type":59,"coordinates":194},[195,196],-1.55336,47.21725,{"lat":196,"lon":195},[199],{"name":200,"role":47,"phone":20,"phoneExt":20,"email":20},"Jean-Baptiste GOURRAUD, MD",{"facility":202,"status":53,"city":203,"state":20,"zip":204,"country":95,"countryCode":96,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"CHU de Bordeaux - Hôpital Cardiologique du Haut-Lévèque","Pessac","33604",{"type":59,"coordinates":206},[207,208],-0.6324,44.80565,{"lat":208,"lon":207},[211],{"name":212,"role":47,"phone":20,"phoneExt":20,"email":20},"Pierre BORDACHAR, MD",{"facility":214,"status":215,"city":216,"state":20,"zip":217,"country":95,"countryCode":96,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"CHU Poitiers","RECRUITING","Poitiers","86021",{"type":59,"coordinates":219},[220,221],0.34348,46.58261,{"lat":221,"lon":220},[224],{"name":225,"role":47,"phone":20,"phoneExt":20,"email":20},"Rodrigue GARCIA, MD",{"facility":227,"status":53,"city":228,"state":20,"zip":229,"country":95,"countryCode":96,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"CHU de Rouen","Rouen","76000",{"type":59,"coordinates":231},[232,233],1.09932,49.44313,{"lat":233,"lon":232},[236],{"name":38,"role":47,"phone":20,"phoneExt":20,"email":20},{"type":238,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[240,243],{"name":241,"class":242},"Medtronic France SAS","INDUSTRY",{"name":244,"class":6},"ClinSearch","100580118","atrioventricular-node-ablation-and-conduction-system-pacing-in-patients-with-well-controlled-permanent-atrial-fibrillation-af-heart-failure-and-preserved-ejection-fraction-heart-rate-regularization-versus-medical-rate-control-100580118",false,"NCT06833138","Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization Versus Medical Rate Control","Atrioventricular (AV) Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization vs. Medical Rate Control","HF-RELIEF","Inclusion Criteria:\n\n* Permanent atrial fibrilation \\> 6 months\n* Preserved Left Ventricular Ejection Fraction ≥ 50%\n* ≥ 1 heart failure hospitalization in the previous year\n* NYHA (New York Heart Association) score ≥ 2\n* Presence of at least one of the following criteria related to diastolic dysfunction:\n\n  * E\u002Fe' ratio \\> 9\n  * Left Ventricular mass \\> 95 g\u002Fm2 (female) or \\> 115 g\u002Fm2 (male) with h\u002FR ratio \\> 0.42\n  * NT pro BNP (B-type Natriuretic Peptide) \\> 365 pg\u002FmL or BNP (B-type Natriuretic Peptide) \\> 105 pg\u002FmL\n* Narrow QRS ≤ 120 ms\n* Average heart rate ≤ 110\u002Fmin on 24 hours Holter monitoring\n* Age over 18-year-old\n* Capacity to understand the nature of the study, legal ability and willingness to give informed consent\n* Patient covered by a social insurance\n* Effective contraception and a negative pregnancy test in women of a childbearing age\n\nExclusion Criteria:\n\n* Patient eligible for atrial fibrilation catheter ablation\n* Life expectancy \\\u003C 12 months\n* Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 20 ml\u002F1,73 m2)\n* Severe respiratory disease (severe chronic obstructive pulmonary disease with Gold ≥ 3 and\u002For chronic oxygen therapy)\n* Class III obesity (Body Mass Index ≥ 40)\n* Confirmed or suspected infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)\n* Obstructive hypertrophic cardiomyopathy\n* Previous implanted devices (Pacemaker \u002F Implantable Cardioverter-Defibrillator \u002F Cardiac Resynchronization Therapy)\n* Other indication for pacemaker implantation\n* Indication for implantable cardioverter-defibrillator\n* Ambulatory ≤ 50% of time\n* Pregnant women\n* Breast-feeding women","ALL","18 Years",{"count":256,"type":257},266,"ESTIMATED","INTERVENTIONAL",[260],"NA","The goal of this clinical trial is to assess the clinical efficacy of physiological pacing combined with atrioventricular node ablation, in patients with Heart Failure with preserved Ejection Fraction (HFpEF) and well controlled permanent atrial fibrillation.The main question it aims to answer is that heart rate regularization added to physiological pacing - preventing the deleterious effect of right ventricular apical pacing - would reduce mortality and heart failure hospitalizations.\n\nResearchers will compare physiological pacing combined with atrioventricular node ablation (intervention arm) versus optimal pharmacological therapy (control arm) to see if physiological pacing combined with atrioventricular node ablation reduce time to the composite of all-cause mortality or hospitalization due to heart failure or intravenous diuretics (time frame 24 months).\n\nParticipants will :\n\n* Be randomized in intervention arm or control arm.\n* Visit the clinic 3 months, 12 months and 24 months after the randomization for checkups and tests.",[263,264],"Heart Failure With Preserved Ejection Fraction","Atrial Fibrillation, Persistent",[266,267,268],"Heart failure","Cardiac Resynchronization Therapy","Conduction System Pacing","2025-09-17",{"date":271,"type":272},"2025-09-22","ACTUAL",{"date":274,"type":272},"2025-09-10",{"date":276,"type":257},"2029-12-31",{"name":5,"class":6},15]