Computed from this object's own state — a structural condition is unmet. This is not a fixed disclaimer: the conditions below are each testable, and a build in which they are met renders READY.
Three trials of transcatheter mitral repair in functional regurgitation, registering three different composites at two different time horizons.
In this section: Registration and administrative information (PROSPERO field set) · What this object claims to contain
| Review title | Transcatheter repair for functional mitral regurgitation |
|---|---|
| Review question (PICO) | Three trials of transcatheter mitral repair in functional regurgitation, registering three different composites at two different time horizons. |
| Population | Patients with symptomatic HFrEF/HFmrEF (LVEF 20-50%) and moderate-severe or severe secondary (functional) MR despite guideline-directed medical therapy |
| Intervention | Transcatheter edge-to-edge repair (MitraClip or Pascal device) plus guideline-directed medical therapy |
| Comparator | Guideline-directed medical therapy alone |
| Background / rationale | Not recorded — this object holds no background field, and an introduction generated without one would be argument that no source in this review supports |
| Eligibility criteria | not recorded on the page this object was built from |
| Information sources | 0 source layers, listed on the Extraction tab |
| Search strategy | The executed strings, datetimes, filters and hit counts are on the Search tab |
| Study selection process | Not recorded — no screening record was recoverable from the page this object was extracted from, so who screened and how cannot be stated |
| Number of screeners | Not recorded — this object records no screener count |
| Data extraction items | Extracted per trial on this object: registry id; primary publication; arms; per-arm counts and the published effect. Fields not listed here were not extracted. |
| Outcomes and prioritisation | Three different registered composites, at 12 and at 24 months |
| Risk of bias method | Not recorded — no per-domain RoB-2 assessment exists yet |
| Synthesis methods | Not recorded — no outcome on this object carries a pooled estimate, so no synthesis method was applied |
| Subgroup analyses | Not recorded — this object records no subgroup-analysis field at all, so whether any were prespecified is UNKNOWN -- which is not the same as none having been |
| Meta-bias assessment | Not recorded — no funnel, Egger or Peters value is held on this object, so no meta-bias assessment is claimed |
| Certainty assessment | Not recorded — no GRADE record was recoverable from the page this object was extracted from |
| Funding | Not recorded — no funding statement is recorded for this review |
| Competing interests | Not recorded — no declaration is recorded |
| Built | 2026-08-18T00:00Z |
| Schema | 2-authored-from-source |
not recorded on the page this object was built from
In this section: Extracted values, and where each came from · References · Included studies · Regulatory documents · Methods and guidance · Sources · Three different registered composites, at 12 and at 24 months · Three different registered composites, at 12 and at 24 months · What was measured · Pooled result · Contributing trials · Endpoint definitions, read from the registry
One row per extracted value. Every row carries the value, the verbatim sentence it was read from, a resolvable link to the source, and whether the number was read or derived. Where any of those is absent the row says so rather than omitting the value.
| Trial / outcome | Value as extracted | Verbatim source sentence | Source links | Read or derived |
|---|---|---|---|---|
| COAPT primary | no effect value held for this outcome | no source sentence recorded — this value cannot be checked against a quoted line here | NCT01626079 · source | DERIVED by us from not carried forward -- the estimate is withdrawn The counts above are what the page held for this trial. The endpoint definition beside them is verbatim from the registry, and is what the withdrawal turns on. |
| MITRA-FR primary | no effect value held for this outcome | no source sentence recorded — this value cannot be checked against a quoted line here | NCT01920698 · source | DERIVED by us from not carried forward -- the estimate is withdrawn The counts above are what the page held for this trial. The endpoint definition beside them is verbatim from the registry, and is what the withdrawal turns on. |
| RESHAPE-HF2 primary | no effect value held for this outcome | no source sentence recorded — this value cannot be checked against a quoted line here | NCT02444338 · source | DERIVED by us from not carried forward -- the estimate is withdrawn The counts above are what the page held for this trial. The endpoint definition beside them is verbatim from the registry, and is what the withdrawal turns on. |
| Layer | Source | How it was obtained |
|---|
| Comparator | guideline-directed medical therapy |
|---|---|
| Estimand | first or recurrent event — random-effects |
| Effect scale | reported on the log scale; nothing is pooled on this outcome |
What this does not establish: not that transcatheter mitral repair does not help in functional mitral regurgitation, and not that COAPT and MITRA-FR disagreeing was a mistake by either. Those two trials enrolled different populations and measured different things over different horizons, which is the leading published explanation for their divergence and is visible directly in their registrations. The trials here measure heart-failure hospitalisation, death and quality of life on three different definitions, and nothing on this page estimates a single quantity across them. What is confirmed: the NOT-POOLABLE verdict was correct before this re-verification and is correct after it -- this is the one topic in the cardiology set that reached the right answer without a detector, by a human noticing that two headline numbers were not comparable. All three identities are correct. The replacement question is parked: reshape-HF2 and COAPT share a 24-month horizon and both count heart-failure hospitalisation, so a synthesis restricted to that component is conceivable -- but one counts recurrent events and the other first events, and reconciling those is an estimand decision needing each trial's own results record.
Three different registered composites, at 12 and at 24 months. k = 3.
Authored on re-verification of a NOT-POOLABLE verdict that was already correct and is now sourced.
What each trial COUNTED, in its own registry record's words, before anything here was pooled. A sentence saying what HAPPENED is not a sentence saying what was COUNTED, and only the second one licenses a pool. Read from the registry on 2026-08-18. Follow the registration link to disagree with any row.
| Trial | Rank in its own trial | Registered outcome measure | Description, verbatim | Analysis set / window |
|---|---|---|---|---|
| COAPT NCT01626079 | PRIMARY -- primaryOutcomes[1] on this registration | Primary Effectiveness Endpoint | Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up | 24 months. Note that the safety primary is measured at 12 months and the effectiveness primary at 24, within one registration. |
| MITRA-FR NCT01920698 | PRIMARY -- primaryOutcomes[0] on this registration | All-cause mortality and unplanned hospitalizations for heart failure | no description registered | 12 months -- half the horizon of the other two trials. |
| RESHAPE-HF2 NCT02444338 | PRIMARY -- primaryOutcomes[0] on this registration | Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months | Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death within 24 months | 24 months for the two event primaries, 12 months for the quality-of-life primary. Its first primary counts recurrent events, not first events. |
In this section: Three different registered composites, at 12 and at 24 months · Risk of bias · GOSH · Trial-sequential analysis · Meta-regression
⬇ SVG (vector) 1 KB
Only the vector format is offered for this figure, by choice: it is line art — discrete marks, glyphs and labels — which SVG reproduces exactly at any size, so a raster would add weight without adding fidelity. The build was able to rasterise; it was asked not to.
Not drawn, because there is nothing to draw it from.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x540 80 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: dd33d4f986f7c7c5), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — gosh.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — gosh.tiff, 5,537 KB.
Deliberately not drawn. Every subset meta-analysis of 3 trials is 7 points; a cloud that small cannot show the multimodality GOSH exists to reveal, and a reader would take the picture as evidence of its absence.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x650 87 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 25ed9800fdf56614), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — tsa.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — tsa.tiff, 6,665 KB.
TSA boundaries depend entirely on a target information size that must be pre-specified. This review's protocol registers none, so any boundary drawn here would be a parameter chosen after seeing the data -- which is the practice TSA exists to protect against.
⬇ SVG (vector) 1 KB ⬇ PNG 3500x540 87 KB
All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 2316b730fa24744e), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — bubble.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — bubble.tiff, 5,537 KB.
The protocol pre-specifies no moderator, and at k = 3 a meta-regression would be fitted on 3 points. Not drawn rather than drawn with a caveat: a bubble plot invites reading a slope, and there is no slope here that any reader should read.
In this section: Summary of findings · Reproducibility artifact · Other recorded qualifications
| Outcome | k | Pooled effect | Certainty |
|---|---|---|---|
| Three different registered composites, at 12 and at 24 months | 3 | not pooled | See comment12 |
| Canonical object | — |
|---|---|
| Registered at | — — |
| Schema | 2-authored-from-source |
| Object last updated | 2026-08-18T00:00Z |
| Source object SHA-256, first 16 hex characters | 575ed7cc8b074785 |
| Page generated | 2026-08-28 07:29 UTC |
| Generator build | 59b484ca7. The standard this page was built to is NOT ESTABLISHED: this object carries no build_stamp, so the version above is the standard that exists now, not the one this page was built against. |
This page CANNOT be rebuilt from what is recorded here: no canonical object is recorded and no registered commit is recorded. Each figure on the Analysis tab downloads as an SVG carrying exactly the values shown.
Statements this review records about the limits of what it establishes, which are not shown elsewhere on this page. They are reproduced from the object verbatim and are not summarised.
| Components as the registry states them | the registered primary effectiveness endpoint. This registration also declares a primary safety endpoint -- 'Percentage of Participants With Freedom From Device Related Complications at 12 Months' -- so it carries two primaries of opposite kind. |
|---|---|
| Analysis set as the registry states it | 24 months. Note that the safety primary is measured at 12 months and the effectiveness primary at 24, within one registration. |
| Components as the registry states them | All-cause mortality and unplanned hospitalisations for heart failure. A two-component composite whose death component is ALL-CAUSE. |
| Components as the registry states them | Three registered primaries: (1) composite rate of recurrent heart-failure hospitalisations and cardiovascular death within 24 months; (2) rate of total, first and recurrent, HF hospitalisations within 24 months; (3) change in quality of life, the KCCQ overall score, at 12 months -- a continuous outcome. |
| Analysis set as the registry states it | 24 months for the two event primaries, 12 months for the quality-of-life primary. Its first primary counts recurrent events, not first events. |
In this section: Summary
Question. Three trials of transcatheter mitral repair in functional regurgitation, registering three different composites at two different time horizons.
What was checked. ClinicalTrials.gov protocol records, read 2026-08-18
What was found. 3 registered trials:
| Registration | Trial |
|---|---|
| NCT01626079 | COAPT |
| NCT01920698 | MITRA-FR |
| NCT02444338 | RESHAPE-HF2 |
Why no result is pooled. Not poolable, and the registry now says why in the trials' own words. The three registrations declare three different primary outcomes at two different horizons. Mitra-fr registers 'All-cause mortality and unplanned hospitalizations for heart failure' at 12 months. Reshape-hf2 registers a 'Composite rate of recurrent heart failure hospitalizations and cardiovascular (cv) death within 24 months' -- cardiovascular death, not all-cause, and recurrent events rather than first events, which is a different counting rule altogether.
Whether these trials study this subject. Checked against each registration's arm structure on 2026-08-25. 3 could NOT be decided this way, because the registered arm names do not name the intervention the way this review does. That is not a pass: they remain unverified, and no other check has looked.
What would change this. A pooled result becomes possible when trials reporting a shared, comparably measured outcome are available.
No pooled estimate, risk-of-bias assessment or certainty rating is published for this question, because there is no combined result for them to describe.
UNSTAMPED — unknown-version. This page carries no build_stamp, so the standard it was built to cannot be established. That is a statement about the record, not a claim that the page is below standard.
Every number on this page is projected from a single canonical object, and each measured cell names the source analysis it was read from. That is what is machine-checked. It does not establish that the underlying sources are right, only that this page faithfully reports them.