[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504997":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":191,"collaborators":25,"id":194,"slug":195,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":196,"sex":202,"minAge":203,"maxAge":25,"enrollmentInfo":204,"targetDuration":25,"studyType":207,"phases":208,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":121,"whyStopped":25,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Bellvitge","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardioneuroablation","EXPERIMENTAL","Bi-atrial ablation of GPs: CARDIONEUROABLATION (Group A, n = 45)",[13],"Procedure: Cardioneuroablation",{"label":15,"type":16,"description":17,"interventionNames":18},"Dual-chamber pacemaker","ACTIVE_COMPARATOR","Implant of a dual-chamber CLS PACEMAKER\\* (Group B, n = 45).\n\n\\*or failing this, a dual-chamber pacemaker with RDR algorithm",[19],"Device: Permanent pacemaker therapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Ganglionated plexi will be localized using an empirical anatomical approach and\u002For a fractionated electrogram-based strategy.\n\nPoint-by-point ablation will be performed using radiofrequency energy and an irrigated tip contact force sensing ablation catheter in a power control mode (35-50 W; AI, 350-500; LSI, 4.5-5.5). The right superior GP (RSGP), left superior GP (LSGP) and posterior left GP (PMLGP) will be targeted during CNA. Radiofrequency applications in other GPs will be left at the discretion of the operator.\n\nAt the end of the procedure, another EP study and atropine test will be performed. Clinical endpoints for completion of the CNA will be: 1) a HR increase \\>20% if the CNA was performed under general anesthesia\u002Fdeep sedation; 2) improved electrophysiological parameters; 3) significant reduction in atropine response (HR increase \\\u003C10% after atropine); and 4) in case of using extracardiac vagal stimulation, lack of response.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Permanent pacemaker therapy","All patients in the pacemaker group will receive a dual-chamber pacemaker that has the ability to be programmed in the DDD-CLS algorithm mode (or failing this, a dual-chamber pacemaker with RDR algorithm).",[15],[32],{"name":33,"affiliation":34,"role":35},"Rodolfo San Antonio, MD, PhD","Hospital Universitario de Bellvitge","STUDY_CHAIR",[37],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","932607500","2710","rsanantonio@bellvitgehospital.cat",[43,62,76,93,108,120,131,148,163,176],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hospital Universitario San Juan de Alicante","NOT_YET_RECRUITING","Sant Joan d'Alacant","Alicante","03550","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],-0.43623,38.40148,{"lat":55,"lon":54},[58,60],{"name":59,"role":38,"phone":25,"phoneExt":25,"email":25},"José Moreno-Arribas, MD, PhD",{"name":59,"role":61,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":63,"status":45,"city":64,"state":65,"zip":66,"country":49,"countryCode":50,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hospital Universitari General de Castellón","Castellon","Castellón","12004",{"type":52,"coordinates":68},[69,70],-0.04935,39.98567,{"lat":70,"lon":69},[73,75],{"name":74,"role":38,"phone":25,"phoneExt":25,"email":25},"Clara Gunturiz, MD",{"name":74,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":77,"status":45,"city":78,"state":79,"zip":80,"country":49,"countryCode":50,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hospital Universitario Álvaro Cunqueiro de Vigo","Vigo","Pontevedra","36312",{"type":52,"coordinates":82},[83,84],-8.72264,42.23282,{"lat":84,"lon":83},[87,89,90],{"name":88,"role":38,"phone":25,"phoneExt":25,"email":25},"Enrique García-Campo, MD",{"name":88,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":91,"role":92,"phone":25,"phoneExt":25,"email":25},"Dahyr Olivas, MD","SUB_INVESTIGATOR",{"facility":94,"status":45,"city":95,"state":25,"zip":96,"country":49,"countryCode":50,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Hospital del Mar","Barcelona","08003",{"type":52,"coordinates":98},[99,100],2.15899,41.38879,{"lat":100,"lon":99},[103,105,106],{"name":104,"role":38,"phone":25,"phoneExt":25,"email":25},"Ermengol Vallès, MD, PhD",{"name":104,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":107,"role":92,"phone":25,"phoneExt":25,"email":25},"Ben Casteigt, MD",{"facility":109,"status":45,"city":95,"state":25,"zip":110,"country":49,"countryCode":50,"cosmosGeoPoint":111,"geoPoint":113,"contacts":114},"Hospital de la Santa Creu i Sant Pau","08025",{"type":52,"coordinates":112},[99,100],{"lat":100,"lon":99},[115,117,118],{"name":116,"role":38,"phone":25,"phoneExt":25,"email":25},"José Guerra, MD, PhD",{"name":116,"role":92,"phone":25,"phoneExt":25,"email":25},{"name":119,"role":61,"phone":25,"phoneExt":25,"email":25},"Francisco Méndez-Zurita, MD",{"facility":34,"status":121,"city":95,"state":25,"zip":122,"country":49,"countryCode":50,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"RECRUITING","08907",{"type":52,"coordinates":124},[99,100],{"lat":100,"lon":99},[127,128,129],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},{"name":33,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":130,"role":61,"phone":25,"phoneExt":25,"email":25},"Ignasi Anguera, MD, PhD",{"facility":132,"status":45,"city":133,"state":25,"zip":134,"country":49,"countryCode":50,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Hospital Universitari Dr. Josep Trueta","Girona","17007",{"type":52,"coordinates":136},[137,138],2.82493,41.98311,{"lat":138,"lon":137},[141,143,144,146],{"name":142,"role":38,"phone":25,"phoneExt":25,"email":25},"Emilce Trucco, MD",{"name":142,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":145,"role":92,"phone":25,"phoneExt":25,"email":25},"Markus Linhart, MD, PhD",{"name":147,"role":92,"phone":25,"phoneExt":25,"email":25},"Eva M Benito, MD",{"facility":149,"status":45,"city":150,"state":25,"zip":151,"country":49,"countryCode":50,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hospital Universitario Nuestra Señora de Candelaria","Santa Cruz de Tenerife","38010",{"type":52,"coordinates":153},[154,155],-16.25462,28.46824,{"lat":155,"lon":154},[158,160,161],{"name":159,"role":38,"phone":25,"phoneExt":25,"email":25},"Luis Álvarez-Acosta, MD",{"name":159,"role":61,"phone":25,"phoneExt":25,"email":25},{"name":162,"role":92,"phone":25,"phoneExt":25,"email":25},"Diego Valdivia, MD",{"facility":164,"status":45,"city":165,"state":25,"zip":166,"country":49,"countryCode":50,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Hospital Universitari i Politècnic La Fe","Valencia","46026",{"type":52,"coordinates":168},[169,170],-0.37966,39.47391,{"lat":170,"lon":169},[173,175],{"name":174,"role":38,"phone":25,"phoneExt":25,"email":25},"Maite Izquierdo, MD, PhD",{"name":174,"role":61,"phone":25,"phoneExt":25,"email":25},{"facility":177,"status":45,"city":178,"state":25,"zip":179,"country":49,"countryCode":50,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Hospital Clínico Universitario Lozano Blesa","Zaragoza","50009",{"type":52,"coordinates":181},[182,183],-0.87734,41.65606,{"lat":183,"lon":182},[186,188,189],{"name":187,"role":38,"phone":25,"phoneExt":25,"email":25},"Javier Ramos-Maqueda, MD, PhD",{"name":187,"role":92,"phone":25,"phoneExt":25,"email":25},{"name":190,"role":61,"phone":25,"phoneExt":25,"email":25},"Isabel Montilla, MD",{"type":61,"investigatorFullName":192,"investigatorTitle":193,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Rodolfo San Antonio","Medical Doctor","100504997","cardioinhibitory-reflex-syncope-permanent-pacemaker-therapy-or-cardioneuroablation-100504997",false,"NCT05855603","Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?","Recurrent Cardioinhibitory Reflex Syncope. PermANent PAcemaker Therapy or CardionEuroablation? A Multicenter RAndomized Clinical Trial","PANACEA","Inclusion Criteria:\n\n* Aged more than 40 years.\n* Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition to at least two presyncopal events, refractory to all recommended types of standard treatment.\n* Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous syncope.\n* If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test.\n* Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope.\n* Significantly decreased quality of life due to syncope.\n* Sinus rhythm on ECGs.\n* Obtained written informed consent.\n\nExclusion Criteria:\n\n* Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation.\n* Evidence of structural heart disease.\n* Contraindications to ablation in the right or left atrium.\n* Life expectancy \\\u003C12 months.\n* Lacking willingness to comply with the randomization procedure.","ALL","40 Years",{"count":205,"type":206},90,"ESTIMATED","INTERVENTIONAL",[209],"NA","Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness. In certain patients, cardiac pacing seem to be beneficial. More recently cardioneuroablation (CNA) has emerged as a novel therapy for reflex syncope. The investigators aim to determine whether CNA is more effective than cardiac pacing at reducing the rate of cardioinhibitory-type reflex syncope.",[212],"Reflex Syncope",[9,214,215],"Permanent cardiac pacing","Vasovagal syncope","2024-01-22",{"date":218,"type":219},"2024-01-25","ACTUAL",{"date":221,"type":219},"2023-11-22",{"date":223,"type":206},"2027-02-22",{"name":5,"class":6},10]