Non-interventional Study on Patients With Atrial Fibrillation and Cancer (BLITZ-AFCancer)

Multicenter, Non-interventional Study on Patients With Atrial Fibrillation (AF) and Cancer (Diagnosed Within the Last 3 Years Prior to Enrolment)

AF and cancer frequently coexist. Since these patients are usually excluded from randomized trials, information on their management and outcome is scarce. Occurrence of relevant clinical events, such as ischemic and hemorrhagic and all-cause mortality and cardiovascular (CV) mortality occurring in patients treated or not with antithrombotic agents needs to be clarified.

A prospective observational registry collecting information, in a real world setting, on the clinical profile of patients with these clinical conditions and on the use of antithrombotic drugs in patients with AF and cancer could improve our knowledge on the management of these high risk patients.

Study Overview

• Status: Completed
• Conditions: Cancer; Atrial Fibrillation

Detailed Description

International, multicenter, non-interventional study on patients with atrial fibrillation (AF) and cancer (diagnosed within the last 3 years prior to enrolment).

The study will be conducted in about 80 sites in italy and 50 sites distributed in other European countries (Belgium, Germany, Ireland, Portugal, Spain, The Netherlands, Turkey).

The study will continue till the consecutive recruitment of 1500 patients. The recruitment period will last approximately 24 months.

Number of visits per patient: Baseline and 1 year (Final). Physicians will not be required to perform any additional tests, assessments, etc., not in line with their routine medical practice.

• Study Type: Observational
• Enrollment (Actual): 1514

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV ZIEKENHUIS AALST - Cardiology
  • Bonheiden, Belgium
    • AZ IMELDA - Cardiology
  • Brugge, Belgium
    • AZ ST-JAN - Cardiology
  • Brussel, Belgium
    • UZ Brussel - Cardiology
  • Brussels, Belgium
    • Hôpital Erasme - Cardiology
  • Brussels, Belgium
    • UCL Cliniques universitaires Saint-Luc - Cardiolgy
  • Genk, Belgium
    • Ziekenhuis Oost-Limburg - Cardiology
  • Hasselt, Belgium
    • JESSA HASSELT - Cardiology
  • Kortrijk, Belgium
    • AZ GROENINGE - Cardiology
  • Leuven, Belgium
    • UZ LEUVEN - Cardiovascular diseases
  • Roeselare, Belgium
    • AZ DELTA ROESELARE - Cardiology
  • Turnhout, Belgium
    • AZ TURNHOUT - Cardiology
• Ireland
  • Cork, Ireland
    • Bon Secours Hospital Cork - Oncology Department
  • Dublin, Ireland
    • Beacon Hospital, Cardiology
  • Dublin, Ireland
    • Tallaght University Hospital - Geriatric and Stroke Medicine Department
• Italy
  • Acquaviva Delle Fonti, Italy
    • Ospedale Miulli - U.O.C. CARDIOLOGIA - UTIC
  • Borgomanero, Italy, 28021
    • Ospedale Ss. Trinita' - S.C. Di Cardiologia
  • Caserta, Italy
    • Az. Ospedaliera S. Anna E S. Sebastiano - Uoc Medicina E Chirurgia D'Urgenza
  • Chieti, Italy
    • Ospedale Policlinico Ss. Annunziata - Medicina Generale Ii
  • Ferrara, Italy
    • Arcispedale Sant'Anna - U.O. Cardiologia - Utic
  • Giugliano In Campania, Italy, 80014
    • Ospedale Generale Di Zona - U.O. Cardiologia - Utic
  • Napoli, Italy, 80131
    • Fondazione Pascale - S.C. Cardiologia
  • Napoli, Italy, 80136
    • Ospedale San Gennaro - U.O. Cardiologia E Riabilitazione Card.
  • Novara, Italy, 28100
    • Aou Maggiore Della Carita' - Cardiologia Ii
  • Pescia, Italy
    • Ospedale Ss. Cosma E Damiano - U. O. Cardiologia - Utic
  • Pozzuoli, Italy, 80078
    • Ospedale Santa Maria Delle Grazie - U.O. Cardiologia - Utic
  • Roma, Italy
    • Ospedale Sandro Pertini, Uoc Cardiologia
  • AG
    • Agrigento, AG, Italy, 92100
      • Ospedale San Giovanni Di Dio - Uo Cardiologia E Utic
    • Canicattì, AG, Italy, 92024
      • Ospedale Barone Lombardo - Cardiologia E Utic
  • AL
    • Casale Monferrato, AL, Italy, 15033
      • Ospedale Santo Spirito - SC Cardiologia
  • AN
    • Fabriano, AN, Italy, 60044
      • Ospedale Civile Profili - U.O. Cardiologia
  • AR
    • Arezzo, AR, Italy, 52100
      • Ospedale San Donato - U.O. Cardiologia
  • BA
    • Bari, BA, Italy, 70123
      • Ospedale San Paolo - Cardiologia-Utic
    • Bari, BA, Italy, 70124
      • Istituto Tumori Giovanni Paolo Ii - U.O. Di Cardiologia
  • BG
    • Treviglio, BG, Italy, 24047
      • Ospedali Treviglio-Caravaggio - Cardiologia
  • BL
    • Belluno, BL, Italy, 32100
      • Ospedale Civile - Sc Cardiologia
    • Feltre, BL, Italy, 32032
      • Ospedale Santa Maria Del Prato - U.O. Di Cardiologia
  • BO
    • Bologna, BO, Italy, 40133
      • Ospedale Maggiore - U.O. Di Cardiologia
    • Bologna, BO, Italy, 40138
      • Ospedale Policlinico S. Orsola-Malpighi - U.O. Cardiologia-Rapezzi
    • Bologna, BO, Italy, 40139
      • Ospedale Bellaria - U.O. Di Cardiologia
  • CA
    • Cagliari, CA, Italy, 09121
      • Ospedale A. Businco - Servizio Di Cardiologia
    • Cagliari, CA, Italy, 09126
      • Ospedale Roberto Binaghi - Servizio Di Cardiologia
  • CE
    • Caserta, CE, Italy, 81100
      • Az. Ospedaliera S. Anna E S. Sebastiano - Cardiologia Clinica Universitaria - Utic
    • Santa Maria Capua Vetere, CE, Italy, 81055
      • Ospedale San Giuseppe E Melorio - U.O.C. Cardiologia Utic
  • CN
    • Mondovì, CN, Italy, 12084
      • Ospedale Regina Montis Regalis - U.O. Cardiologia-Utic
    • Savigliano, CN, Italy, 12038
      • Ospedale Maggiore Ss. Annunziata - Sc Cardiologia
  • CS
    • Castrovillari, CS, Italy, 87012
      • Ospedale Civile Ferrari - U.O.C. Cardiologia-Utic
    • Paola, CS, Italy, 87027
      • Ospedale Spoke Paola- Cetraro Po Paola - Utic Cardiologia
  • CT
    • Catania, CT, Italy, 95122
      • P.O. Garibaldi-Nesima - U.O.C. Di Cardiologia
    • Catania, CT, Italy, 95126
      • Azienda Ospedaliera Cannizzaro - Uoc Cardiologia Con Utic Ed Emodinamica
    • Catania, CT, Italy, 95126
      • Humanitas Centro Catanese Di Oncologia - Servizio Di Cardiologia
  • FG
    • Foggia, FG, Italy, 71100
      • Ospedali Riuniti - S.C. Di Cardiologia Univ.-Utic
  • FI
    • Empoli, FI, Italy, 50053
      • Ospedale Civile San Giuseppe - Cardiologia
    • Firenze, FI, Italy, 50124
      • Ospedale San Giovanni Di Dio - Cardiologia
    • Firenze, FI, Italy, 50134
      • Aou Careggi - Cardiologa Diagnostica
    • Firenze, FI, Italy, 50139
      • Aou Careggi - Diagnostica Cardiovascolare
  • GE
    • Genova, GE, Italy, 16132
      • Ospedale Policlinico San Martino - Clinica Malattie Cardiovascolari
    • Genova, GE, Italy, 16153
      • Ospedale Padre Antero Micone - Sc Cardiologia - Utic
  • LE
    • Copertino, LE, Italy, 73043
      • Ospedale San Giuseppe Da Copertino - U.O. Di Cardiologia-Utic
    • Scorrano, LE, Italy, 73020
      • Ospedale Ignazio Veris Delli Ponti - Uoc Cardiologia-Utic
  • LU
    • Lido Di Camaiore, LU, Italy, 55043
      • Nuovo Ospedale Versilia - Sc Cardiologia
  • ME
    • Messina, ME, Italy, 98124
      • Policlinico G. Martino - U.O. Medicina Interna
  • MI
    • Milano, MI, Italy, 20133
      • Istituto Nazionale Tumori - Struttura Complessa Di Cardiologia
    • Milano, MI, Italy, 20141
      • Istituto Europeo Di Oncologia - Cardiologia
    • Milano, MI, Italy, 20162
      • Asst Ospedale Metropolitano Niguarda - Cardiologia 4 -Diagnost. E Riabilitativa
    • Vizzolo Predabissi, MI, Italy, 20077
      • Ospedale Di Vizzolo Predabissi - Uo Cardiologia E Ucc
  • MO
    • Carpi, MO, Italy, 41013
      • Ospedale Ramazzini - U.O. Cardiologia
    • Sassuolo, MO, Italy, 41049
      • Ospedale Di Sassuolo - Cardiologia
  • NU
    • Nuoro, NU, Italy, 08100
      • Ospedale San Francesco - Cardiologia - Utic
  • PA
    • Cefalù, PA, Italy, 90015
      • Fondazione G. Giglio - U.O. Cardiologia E Utic
    • Palermo, PA, Italy, 90146
      • Aor Villa Sofia-Cervello P.O. Cervello, Uo Cardiologia - Cervello
  • PD
    • Padova, PD, Italy, 35128
      • Istituto Oncologico Veneto - Cardiologia Oncologica
  • PE
    • Pescara, PE, Italy, 65124
      • Ospedale Civile Dello Spirito Santo - Utic E Cardiologia Interventistica
  • PI
    • Pisa, PI, Italy, 26124
      • Azienda Ospedaliera Universitaria Pisana - U.O. Malattie Cardiovasc. I - Cisanello
  • PN
    • Aviano, PN, Italy, 33081
      • Centro Di Riferimento Oncologico (Cro) - Cardiologia
  • PU
    • Pesaro, PU, Italy, 61121
      • Presidio Ospedaliero San Salvatore - Cardiologia E Utic
  • PV
    • Pavia, PV, Italy, 27100
      • Fondazione Irccs Policlinico San Matteo - Cardiologia
    • Pavia, PV, Italy, 27100
      • Ics Maugeri Spa Societa' Benefit - U.O. Di Riabilitazione Cardiologica
  • RA
    • Ravenna, RA, Italy, 48100
      • Ospedale Civile Santa Maria Delle Croci - U.O. Di Cardiologia
  • RC
    • Polistena, RC, Italy, 89024
      • Ospedale Santa Maria Degli Ungheresi - Uoc Cardiologia-Utic
    • Reggio Calabria, RC, Italy, 89124
      • Grande Ospedale Metropolitano-Bianchi Melacrino Morelli - Divisione Di Cardiologia
  • RE
    • Guastalla, RE, Italy, 42016
      • Ospedale Civile - Sc Cardiologia Area Nord
    • Reggio Emilia, RE, Italy, 42100
      • Arcispedale Santa Maria Nuova - S.C. Cardiologia
  • RG
    • Ragusa, RG, Italy, 97100
      • Ospedale Giovanni Paolo Ii - U.O.C. Cardiologia-Utic
  • RM
    • Ariccia, RM, Italy, 00072
      • Nuovo Ospedale Dei Castelli - U.O.C. Di Cardiologia E Utic
    • Roma, RM, Italy, 00135
      • P.O. San Filippo Neri - Asl Roma 1 - Uoc Cardiologia E Utic
    • Roma, RM, Italy, 00151
      • Ospedale San Camillo - Uosd Servizi Cardiologici Integrati
    • Roma, RM, Italy, 00152
      • Ifo- Istituto Naz. Tumori Regina Elena - Uo Cardiologia
    • Roma, RM, Italy, 00128
      • Campus Biomedico - Cardiologia
    • Roma, RM, Italy, 00168
      • Policlinico Agostino Gemelli - Uo Cardiologia Per Sc E Riab. Cardiolog.
  • RN
    • Riccione, RN, Italy, 47838
      • Ospedale G. Ceccarini - Cardiologia-Utic
  • SA
    • Salerno, SA, Italy, 84131
      • Aou S. Giovanni Di Dio-Ruggi D'Aragona - Cardiologia Intensiva
  • SI
    • Poggibonsi, SI, Italy, 53036
      • Ospedale Dell'Alta Val D'Elsa - Uosd Cardiologia-Utic
  • SP
    • Sarzana, SP, Italy, 19038
      • Ospedale San Bartolomeo - U.O. Cardiologia Clinica-Riabilitativa
  • SR
    • Augusta, SR, Italy, 96011
      • Ospedale E. Muscatello - U.O. Di Cardiologia - Utic
  • TA
    • Castellaneta, TA, Italy, 74011
      • Ospedale Di Castellaneta - S.C. Cardiologia
    • Manduria, TA, Italy, 74024
      • Ospedale Civile M. Giannuzzi - Cardiologia E Utic
    • Martina Franca, TA, Italy, 74015
      • Presidio Ospedaliero Della Valle D'Itria - Struttura Complessa Di Cardiologia
  • TE
    • Teramo, TE, Italy, 64100
      • Ospedale Civile G. Mazzini - Cardiologia Utic Ed Emodinamica
  • TN
    • Rovereto, TN, Italy, 38068
      • Ospedale Santa Maria Del Carmine - Cardiologia
  • TO
    • Orbassano, TO, Italy, 10043
      • Ospedale San Luigi Gonzaga - S.C.D.O. Cardiologia
    • Pinerolo, TO, Italy, 10064
      • Ospedale Civile E. Agnelli - Sc Di Cardiologia
    • Rivoli, TO, Italy
      • Ospedale Degli Infermi, Sc Cardiologia
    • Torino, TO, Italy, 10126
      • Aou Citta' Della Salute E Della Scienza - S.C.D.U. Cardiologia
    • Torino, TO, Italy, 10128
      • Ospedale Mauriziano Umberto I - Sc Cardiologia
    • Torino, TO, Italy, 10153
      • Ospedale Humanitas Gradenigo - Cardiologia
    • Torino, TO, Italy, 10155
      • Ospedale Giovanni Bosco - Sc Cardiologia
  • TP
    • Alcamo, TP, Italy, 91011
      • Ospedale Ss. Vito E Spirito - U.O.S. Di Cardiologia
  • TR
    • Terni, TR, Italy, 05100
      • Azienda Ospedaliera Santa Maria - S.C. Di Cardiologia
  • TS
    • Trieste, TS, Italy, 34125
      • Asui Trieste - S.C. Centro Cardiovascolare
  • UD
    • Udine, UD, Italy, 33100
      • Pou Santa Maria Della Misericordia - S.O.C. Cardiologia
  • VA
    • Saronno, VA, Italy, 21047
      • Presidio Ospedaliero Di Saronno - U.O.C. Di Cardiologia
  • VE
    • Mirano, VE, Italy, 30035
      • Ospedale Civile - U.O. Cardiologia
  • VI
    • Arzignano, VI, Italy, 36071
      • Ospedale Civile - U.O.C. Cardiologia
  • VR
    • Negrar, VR, Italy, 37024
      • Ospedale Sacro Cuore - U.O. Di Cardiologia
• Netherlands
  • Arnhem, Netherlands
    • Rijnstate Ziekenhuis - Afdeling Cardioresearch
  • Blaricum, Netherlands
    • Tergooi - Poli cardiologie / poli 2
  • Breda, Netherlands
    • Amphia Ziekenhuis - Research Cardiologie
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis - Research Cardiologie
  • Groningen, Netherlands
    • Martini Ziekenhuis - Dept. Cardio Research Noord BV
  • Utrecht, Netherlands
    • Diakonessenhuis - Research Cardiologie
  • Utrecht, Netherlands
    • University Medical Center Utrecht - Cardiologie
  • Veldhoven, Netherlands
    • Máxima Medisch Centrum - Poli Cardiologie
• Portugal
  • Amadora, Portugal
    • Prof. Doutor Fernando Fonseca EPE Hospital, Cardiologia
  • Barreiro, Portugal
    • Hospital Nossa Senhora do Rosário, Cardiology
  • Lisboa, Portugal
    • Hospital da Luz
  • Lisboa, Portugal
    • Hospital de Santa Cruz, Cardiology
  • Lisboa, Portugal
    • Hospital Santa Maria, Cardiology
• Spain
  • Barcelona, Spain
    • Hospital del Mar (Parc de Salut Mar),Cardiologa I Unitat Coronaria
  • Jaén, Spain
    • Hospital Médico-Quirúrgico, Cardiology
  • Madrid, Spain
    • Hospital Ramón y Cajal
  • Madrid, Spain
    • Hospital La Paz
  • Madrid, Spain
    • Hospital la Zarzuela
  • Madrid, Spain
    • Clínica Anderson, Oncología Médica
  • Madrid, Spain
    • Clínica Medicentro, Cardiología
  • Madrid, Spain
    • Hopsital Puerta de Hierro
  • Madrid, Spain
    • Hospital La Moraleja, Servicio de Cardiología
  • Madrid, Spain
    • Hospital Montepríncipe, Cardiología
  • Madrid, Spain
    • Hospital Rúber Internacional, Oncología
  • Madrid, Spain
    • Hospital Universitario Gregorio Marañón, Servicio de Cardiología
  • Murcia, Spain
    • Hospital Virgen de Arrixaca - Cardiologia
  • Salamanca, Spain
    • Hospital de Salamanca, Cardiología
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena, Cardiologia
  • Torrejón De Ardoz, Spain
    • Hospital de Torrejón
  • Valladolid, Spain
    • University Clinical Hosp. de Valladolid, Cardiología
  • Valladolid, Spain
    • Hospital Universitario Río Hortega, Cardiología
  • Zaragoza, Spain
    • Hospital Clínico "Lozano Blesa", Cardiologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment) and with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented.

Description

Inclusion Criteria:

• Both sexes
• Age >18 years
• Patient with diagnosed AF (any type of AF, electrocardiographically documented within 1 year prior to enrolment)
• Patient with a documented cancer (diagnosed within the last 3 years prior to enrolment into this registry), including melanoma but not other basal-cell or squamous-cell carcinoma of the skin. The diagnosis/history of cancer must be objectively documented.
• Written informed consent (IC) for participation in the study
• Patient not simultaneously participating in any interventional study.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy	Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy	Baseline
Patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy	Number of patients with AF and cancer treated with oral anticoagulant therapy and with other antithrombotic therapy	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all cause stroke	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing transient ischemic attacks	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death)	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major adverse cardiovascular events (non fatal MI, non fatal stroke, non fatal systemic embolic events, cardiovascular death)	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing systemic embolic events	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing acute coronary syndrome	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing venous thromboembolic events, defined as composite of deep vein thrombosis and pulmonary embolism	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing deep vein thrombosis	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing pulmonary embolism	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing major bleeding (Fatal bleeding, Non-fatal bleeding,Intracranial hemorrhage	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing clinically relevant non-major bleeding	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing composite of major and CRNM bleeding	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing all-cause death	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing cardiovascular death	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing death due to malignancy	Baseline and 12 months
Patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death	Number of patients treated with oral anticoagulant therapy, other antithrombotic therapy or not treated experiencing sudden and unexplained death	Baseline and 12 months
Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes	Number of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes	Baseline and 12 months
Association of various antithrombotic treatments (or lack of) on hospital admissions due to CV or non CV causes	Length of hospital admissions (defined as ≥ 24 h stay in a hospital) due to CV or non CV causes;	Baseline and 12 months
Treatment satisfaction	Treatment satisfaction as assessed by the Perception Anticoagulant Treatment Questionnaire (PACT-Q)	Baseline and 12 months
Quality of life satisfaction	Health related quality of life as assessed by the EuroQol (EQ-5D-5L) questionnaire	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Heart Care Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: K21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No