NCT04259411

Brief Summary

The MitraClip System is the first commercially available catheter-based option for the treatment of MR. The MitraClip System was developed as an alternate percutaneous technology which may serve as a viable therapeutic option for open-heart surgery. Treatment with the MitraClip device allows patients to undergo a less invasive procedure that can mechanistically reduce MR and allow for improved quality of life. The MitraClip procedure is performed under general anesthesia without the use of a heart-lung machine, with recovery typically lasting two to three days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 6, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

September 23, 2019

Results QC Date

November 11, 2025

Last Update Submit

December 12, 2025

Conditions

Mitral Regurgitation

Keywords

MRMitral RegurgitationMitraClip

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants With Acute Procedural Success (APS)

    APS is defined as successful implantation of the MitraClip device(s) with resulting MR severity of 2+ or less as determined by the ECL assessment of a discharge echocardiogram (30-day echocardiogram will be used if discharge echocardiogram is unavailable or uninterpretable).

    Discharge/30days

  • Percentage of Participants With Freedom From Major Adverse Event (MAE)

    A Major Adverse Event (MAE) was determined as the composite of death, stroke, myocardial infarction (MI), renal failure, and non-elective cardiovascular surgery for device- or procedure-related adverse events occurring after the femoral vein puncture for transseptal access.

    30 days

Study Arms (1)

MitraClip

EXPERIMENTAL

Subject will receive MitraClip procedure with MitraClip NTR System or MitraClip XTR System.

Device: MitraClip procedure

Interventions

MitraClip procedureDEVICE

MitraClip procedure with MitraClip NTR System or MitraClip XTR System

MitraClip

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects is eligible to receive the MitraClip per the current approved MitraClip System IFU. (If any update or amendment on the IFU, the latest version of IFU shall be followed.)
  • Subject is 18 years-old or above.
  • Subjects who give consent for study procedure.

You may not qualify if:

  • Subject cannot tolerate procedural anticoagulation or anti-platelet regimen.
  • Subject with active endocarditis of mitral valve.
  • Subject with rheumatic mitral valve disease.
  • Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus.
  • Subject is unlikely to survive the protocol follow up period of 12-months after device implant.
  • Subject has insufficient or lost ability to maintain their will and rights.
  • Subject is illiterate.
  • Pregnant or nursing subjects and those who plan pregnancy during the study follow-up period
  • Subject participates in another clinical study that may impact the follow-up or results of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Fuwai Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361008, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

The 2nd Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Janani Aiyer/ Clinical Scientist II
Organization
Abbott Structural Heart
Janani.aiyer@abbott.com
+1(669)287-4507

Study Officials

  • Kyle J Brunner

    Abbott Structural Heart

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2019

First Posted

February 6, 2020

Study Start

December 6, 2021

Primary Completion

May 29, 2024

Study Completion

March 7, 2025

Last Updated

December 15, 2025

Results First Posted

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)