Early Feasibility Study of the Capstan Medical TMVR System

NCT07917208, Not applicable, Recruiting, Capstan Medical

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Early Feasibility Study of the Capstan Medical TMVR System	ClinicalTrials.gov
NCT number	NCT07917208	ClinicalTrials.gov
Status	Recruiting	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	15 participants, estimated	ClinicalTrials.gov
Lead sponsor	Capstan Medical	ClinicalTrials.gov
Conditions	Mitral Regurgitation (MR)	ClinicalTrials.gov
Interventions	Capstan Compass Robotic System for Transcatheter Mitral Valve Replacement	ClinicalTrials.gov
First posted	2026-11-04	ClinicalTrials.gov
Last updated	2026-11-09	ClinicalTrials.gov

Registered outcomes 14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Primary Safety Endpoint	30 Days	Evaluate serious adverse events associated with the delivery and/or implantation of the device.	ClinicalTrials.gov
Primary	Primary Performance Endpoint	At the end of the procedure	Successful insertion, delivery, deployment, and retrieval of the delivery catheter defined as the proportion of patients presented as n/N (%) with device successfully inserted, delivered, deployed, and retrieved as defined by MVARC.	ClinicalTrials.gov
Primary	Primary Performance Endpoint	At the end of the procedure	Successful deployment of the implant in the intended target location defined as the proportion of patients presented as n/N (%) with implant successfully deployed in the intended target location as defined by MVARC.	ClinicalTrials.gov
Primary	Primary Performance Endpoint	At the end of the procedure	Freedom from emergency surgery related to the investigational device or procedure based upon reported adverse events.	ClinicalTrials.gov
Primary	Primary Performance Endpoint	30 Days	Freedom from device- or procedure-related mortality based upon reported adverse events.	ClinicalTrials.gov
Primary	Primary Performance Endpoint	30 Days	Freedom from emergency surgery related to the investigational device or procedure based upon reported adverse events.	ClinicalTrials.gov
Primary	Primary Performance Endpoint	30 Days	Freedom from device- or procedure-related reintervention based upon reported adverse events.	ClinicalTrials.gov
Secondary	Secondary Safety Endpoint	30 Days	Rate of hemolysis and hemolytic anemia from reported adverse events.	ClinicalTrials.gov
Secondary	Secondary Safety Endpoint	30 Days	Rate of anaphylactic reactions from reported adverse events.	ClinicalTrials.gov
Secondary	Secondary Performance Endpoint	Through 5 Years	Reduction in mitral regurgitation grade from echo analysis.	ClinicalTrials.gov
Secondary	Secondary Performance Endpoint	Through 5 Years	The degree of improvement in symptoms and Quality of Life as measured by NYHA functional class.	ClinicalTrials.gov
Secondary	Secondary Performance Endpoint	Through 5 Years	The degree of improvement in symptoms and Quality of Life as measured by KCCQ-12.	ClinicalTrials.gov
Secondary	Secondary Performance Endpoint	Through 5 Years	The degree of improvement in symptoms and Quality of Life as measured by 6MWT.	ClinicalTrials.gov
Secondary	Secondary Performance Endpoint	At the end of the procedure	Robotic Technical Success defined as the absence of manual conversion.	ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units	Source

Participant flow 0

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted	Source

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source

Adverse event totals 0

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)