EFS of the CardioMech MVRS

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

• ✓
  Present: Registered before enrolment beganFirst posted 2021-03-29; recorded start 2021-07-27
• ✓
  Present: Has a defined primary outcomeA primary outcome measure is listed in the record
• ✓
  Present: The primary outcome states a time frameThe primary outcome measure records a time frame
• —
  Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
• —
  Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
• —
  Not stated: Open label (no blinding)Masking is recorded as none (open label)
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  Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
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  Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
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  Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
• ✓
  Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
• —
  Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (CardioMech AS)
• —
  Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

• The record lists 1 condition.
• Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1