Valvular & structural heart disease
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium
Authors' conclusion
The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient.
Study context
- Population
- Published prospective studies of 71 high-risk CV devices in 7 classes (bioresorbable coronary scaffolds, LAAO devices, TAVI systems, transcatheter mitral repair/replacement, surgical aortic and mitral valves, leadless pacemakers, subcutaneous ICD), 2000–21
- Participants
- 97,886 participants308 studies
- Comparison
- Studies published before vs after CE-mark approval; RCTs vs non-randomised trials
- Non-randomized clinical trialsn = 251
- Randomized clinical trialsn = 57
- Outcome
- Quantity and quality of published prospective clinical evidence for 71 high-risk CV devices, by CE-mark timing
Methodological detailspre-specified search strategies
- Pre-specified search strategies
Pooled result
As reported in the abstract
- Devices with ≥1 prospective clinical trial
- 70% (50/71)
- Eligible prospectively designed studies (473 reports)
- 308
- Individuals enrolled
- 97 886
- Prospective non-randomized clinical trials
- 81% (251/308)
- RCTs
- 19% (57/308)
- Pre-registered study protocol
- 49% (150/308)
- Peer-reviewed publicly available protocol
- 16% (48/308)
- Device-related adverse events evaluated
- 82% (253/308)
- Outcome adjudication process reported
- 39% (120/308)
- RCTs published before CE-mark approval
- 0
- Non-randomized trials published after CE-mark approval
- 89%, 224/251
Further pooled results
Sample size, by trial design
P < 0.001
Sample size, published before vs after CE-mark approval
Individuals
- Median sample size before CE-mark approval
- 31
- Median sample size after CE-mark approval
- 135
- P < .001
Trials with larger samples (>50 individuals) or longer recruitment
- More likely published after CE-mark approval; more frequent in 2016-21
Original publication
Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium. Eur Heart J. Published 28 August 2023. doi:10.
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