Clinical Evidence

Clinical progress across Pivot Bridge and Pivot Extend.

In its first‑in‑human study, Pivot Bridge® reduced tricuspid regurgitation, improved right‑heart structure, and eased symptoms in patients with severe secondary TR. Building on this clinical foundation, Pivot Extend® is being evaluated in an ongoing Early Feasibility Study in Australia, expected to conclude by the end of 2026. Tau Medical is also expanding clinical and compassionate‑use experience across key regions.

Study overview

Pivot Bridge first‑in‑human study

A multicenter study of short-term Pivot Bridge implantation in patients with severe, symptomatic secondary tricuspid regurgitation.

Pivot Bridge device
Study design
Multicenter, single-arm, short-term implantation study
Sites
11 hospitals in Korea
Enrollment
15 patients enrolled of 19 screened
Population
Severe, symptomatic secondary TR
Implant duration
Up to 7 days (temporary)
Imaging analysis
Echocardiography and cardiac CT with core-lab review
Link
NCT05854095
Publication
Catheter Cardiovasc Interv. 2026;107:2069–2077

Study overview

Pivot Extend Australia EFS

A first‑in‑human Early Feasibility Study evaluating the safety, feasibility, and preliminary clinical response of permanent Pivot Extend implantation in patients with severe, symptomatic tricuspid regurgitation.

Pivot Extend device
Study design
Prospective, single-site, open-label, single-arm, first‑in‑human EFS
Site
1 site in Australia
Enrollment
10 planned implants (7 completed to date)
Population
Severe, symptomatic TR
Implant
Permanent transcatheter spacer system
Primary endpoint
Device- or procedure-related MACE through Day 30
Follow-up
Through Day 365 after implantation
Imaging analysis
Serial echocardiography and cardiac CT with independent core-lab analysis
Link
NCT06877520

Results

What the study showed.

Pivot Bridge, pre-operative stabilization, 1-week post implant.

Procedural outcomes

100%

procedural success (15/15)*

47 min

mean procedure time

0

serious adverse events during implantation

TR reduction

−50%

mean vena contracta width

−50%

mean EROA

Effective regurgitant orifice area
15/15

patients with at least one-grade TR reduction

Anatomical stabilization

−10.2%

mean change in tricuspid annulus area**

3D TTE
−8.1%

RV end-diastolic volume**

Cardiac CT

Clinical stabilization

−1.5 kg

body weight

p<0.05
+10%

eGFR

p<0.05
NYHA class, average before and after implantationp<0.05

Results from a single-arm study of 15 patients with temporary implantation; there was no control group. Values are study averages. Pivot Bridge is an investigational device, and its safety and effectiveness have not been established.

*Procedural success as reported by the study investigators; see the original publication for the definition.

**Tricuspid annulus area 21.5 ± 5.0 → 19.3 ± 2.7 cm² (3D TTE); RV end-diastolic volume 320.2 ± 93.7 → 294.4 ± 81.1 mL (cardiac CT). Mean ± SD, baseline → follow-up.

EROA: effective regurgitant orifice area. RV: right ventricle. eGFR: estimated glomerular filtration rate. NYHA: New York Heart Association. TTE: transthoracic echocardiography.

Source: Catheter Cardiovasc Interv. 2026;107:2069–2077. NCT05854095. NYHA class, eGFR, and body weight: data on file, Tau Medical.

First page of the Pivot-Bridge first-in-human article in Catheterization and Cardiovascular InterventionsView publication

Clinical program

A growing clinical program.

Clinical and compassionate-use programs for Pivot Extend and Pivot Bridge are expanding to medical institutions in seven regions.

  • Korea
  • Australia
  • Canada
  • USA
  • Japan
  • India
  • EU
World map marking the seven regions with clinical and compassionate-use programsKoreaJapanIndiaEUCanadaUSAAustralia
50+ patients treated across clinical and compassionate-use programs (as of August 2026)
Pivot Bridge

First-in-human study

South Korea

Multicenter, single-arm, implantation for up to 7 days

CompletedNCT05854095
Pivot Bridge

Acute safety and efficacy study

South Korea

Self-controlled comparison of medical therapy alone with Pivot Bridge plus medical therapy, in massive or greater functional TR

RecruitingNCT07385625
Pivot Bridge

EU CE Mark pivotal study

EU + Switzerland

Multicenter

PlanningTBA
Pivot Extend

SPACER early feasibility study, Australia

Australia

Safety, device success, and procedural success in severe, symptomatic TR

RecruitingNCT07172477
Pivot Extend

SPACER early feasibility study, Georgia

Georgia

Permanent implant for the treatment of TR

RegisteredNCT06877520
Pivot Extend

SPACER early feasibility study, US

USA

Safety, device success, and procedural success in severe, symptomatic TR

PlanningTBA
Pivot Extend

SPACER early feasibility study, Japan

Japan

Multicenter, single-arm, investigator-initiated research (IIR)

RecruitingjRCTs032260313
Pivot Extend

EU CE Mark pivotal study

EU + Switzerland

Multicenter

PlanningTBA
MTR Combo

First-in-human study

TBA

Single-center

PlanningTBA
Pivot‑TR

First-in-man temporary implantation

South Korea

One-hour temporary implantation; results presented at EuroPCR 2023

PresentedNCT05648838

Status as last listed on ClinicalTrials.gov or reported by Tau Medical. Check each registry record for the current status.

Compassionate-use experience

Challenging anatomy. Complex patients.

Pivot Extend has been used under compassionate-use pathways in patients with severe tricuspid regurgitation and challenging anatomical or clinical characteristics, including those previously considered untreatable.

No limit to annular dimension

Largest coaptation gap to date was ~42 mm.

Pacemaker leads

multiple lead-associated TR cases

3 regions and counting

EU, Oceania, Asia

High-risk profile

cases with RV dysfunction, pulmonary hypertension, renal impairment, or prior interventions

Explore the research.

Browse all publications behind the Pivot‑TR® platform, or follow the latest clinical updates.

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