Current challenges for clinical trials of cardiovascular medical devices

International Journal of Cardiology

Volumn 175, Issue 1, 2014, Pages 30-37

  Zannad, Faiez ^a,b   Stough, Wendy Gattis ^c   Piña, Ileana L ^d   Mehran, Roxana ^e,f   Abraham, William T ^g   Anker, Stefan D ^h   De Ferrari, Gaetano M ⁱ   Farb, Andrew ^j   Geller, Nancy L ^k   Kieval, Robert S ^l   Linde, Cecilia ^m   Redberg, Rita F ⁿ   Stein, Kenneth ^o   Vincent, Alphons ^p   Woehrle, Holger ^q,r   Pocock, Stuart J ^s  

^a INSERM   (France)

^b UNIVERSITÉ DE LORRAINE   (France)

^c CAMPBELL UNIVERSITY   (United States)

^d MONTEFIORE MEDICAL CENTER   (United States)

^e CARDIOVASCULAR RESEARCH FOUNDATION   (United States)

^f MOUNT SINAI MEDICAL CENTER   (United States)

^g THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

^h CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

ⁱ FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^j CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^k NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^l CVRX INC   (United States)

^m KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

ⁿ UNIVERSITY OF CALIFORNIA   (United States)

^o BOSTON SCIENTIFIC CORPORATION   (United States)

^p Medtronic ^*  (Switzerland)

^q ResMed Science Center   (Germany)

^r Sleep and Ventilation Center Blaubeuren Lung Center   (Germany)

^s LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

more..

Author keywords

Cardiovascular devices; Clinical trial; Device approval; Research design

Indexed keywords

AMIODARONE;

BLEEDING; CARDIAC RESYNCHRONIZATION THERAPY; CARDIOVASCULAR DISEASE; CARDIOVASCULAR THERAPEUTIC DEVICE; CLINICAL ASSESSMENT TOOL; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; CLINICAL PRACTICE; CLINICAL TRIAL; CORONARY ARTERY BYPASS GRAFT; CORONARY ARTERY DISEASE; DEVICE APPROVAL; DEVICE SAFETY; DEVICE THERAPY; EVIDENCE BASED MEDICINE; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE ACCESS; HEALTH CARE POLICY; HEART ARRHYTHMIA; HEART DENERVATION; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE REVASCULARIZATION; HUMAN; HYPERTENSION; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; KIDNEY ANGIOGRAPHY; LEFT CARDIAC SYMPATHETIC DENERVATION; MEDICAL DEVICE COMPLICATION; OBJECTIVE PERFORMANCE CRITERIA; OBSERVATIONAL STUDY; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY OF LIFE; RADIOFREQUENCY ABLATION; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REIMBURSEMENT; RELIABILITY; REVIEW; SELECTION BIAS; UNIQUE DEVICE IDENTIFIER SYSTEM; CARDIOVASCULAR DISEASES; EQUIPMENT DESIGN; MEDICAL DEVICE REGULATION; MEDICAL RESEARCH; STANDARDS; TRENDS;

BIOMEDICAL RESEARCH; CARDIOVASCULAR DISEASES; DEVICE APPROVAL; EQUIPMENT DESIGN; HUMANS; MEDICAL DEVICE LEGISLATION; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84902536277     PISSN: 01675273     EISSN: 18741754     Source Type: Journal    
DOI: 10.1016/j.ijcard.2014.05.021     Document Type: Review

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