NCT02787408

Brief Summary

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
5 countries

11 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

April 11, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

October 25, 2022

Completed
Last Updated

October 25, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

April 11, 2016

Results QC Date

September 21, 2021

Last Update Submit

April 4, 2022

Conditions

Tricuspid Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • All-cause Mortality

    The primary endpoint for the study will assess the all-cause mortality of the as treated cohort at 30 days compared to a literature derived Performance Goal based on high-risk surgical outcomes for tricuspid repair/replacement. Due to the early termination of the study, the desired statistical power was not attained and thus this comparison analysis was not performed. All-cause mortality is presented below as a number of deaths and percentage of patients only.

    At 30 days.

Secondary Outcomes (10)

  • Technical Success

    Implant Procedure

  • Device Success

    At 1 month, 6 months, 1, 2, and 3 years

  • Procedural Success

    At 1 month

  • Clinical Outcomes [Heart Failure Re-Hospitalization Rates]

    At 1 month, 6 months, 1, 2 and 3 years

  • Clinical Outcomes [Tricuspid Regurgitation Re-Intervention Rates]

    At 1 month, 6 months, 1, 2 and 3 years

  • +5 more secondary outcomes

Study Arms (1)

EW Tricuspid Transcatheter Repair System

EXPERIMENTAL

Edwards (EW) Tricuspid Transcatheter Repair System

Device: EW Tricuspid Transcatheter Repair System

Interventions

EW Tricuspid Transcatheter Repair SystemDEVICE

Treatment with the EW Tricuspid Transcatheter Repair System

EW Tricuspid Transcatheter Repair System

Eligibility Criteria

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

You may qualify if:

  • Signed and dated Ethics Committee (EC) approved study consent form prior to study related procedures
  • Eighteen years of age or older
  • Clinically significant, symptomatic (New York Heart Association (NYHA) Functional Class II or greater), tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team
  • Functional tricuspid regurgitation as the primary etiology
  • New York Heart Association (NYHA) Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
  • Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement and the benefit-risk analysis supports utilization of the investigational device
  • Willing to attend study follow-up assessments for up to 3 years

You may not qualify if:

  • Tricuspid valve/right heart anatomy not suitable for the study device:
  • Native tricuspid annulus area \< 2.14 cm2 (9 mm device) or \< 2.63 cm2 (12 mm device) or \< 3.27cm2 (15 mm device) as measured by transthoracic echocardiography
  • Sub-valvular structures/anatomy that would preclude from proper anchor or coaptation device placement, positioning and retrieval
  • Access pathway vessel diameter less than 7.1 mm (9, 12 mm and 15 mm devices)
  • Moderate or greater tricuspid valve stenosis
  • Untreated clinically significant coronary artery disease requiring immediate revascularization
  • Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
  • Patients not already receiving dialysis with renal insufficiency (eGFR \<25) per lab test ≤ 48 hours prior to scheduled implant procedure
  • Myocardial infarction within 30 days of scheduled implant procedure
  • Hemodynamic instability within 30 days of scheduled implant procedure
  • Patient requiring surgery under general anesthesia for any reason within 90 days of scheduled implant procedure
  • Severe left ventricular dysfunction with ejection fraction \< 25% within 90 days of scheduled implant procedure
  • Patients with pulmonary artery systolic pressure \> 70 mmHg via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 90 days
  • Concomitant clinically significant valve (aortic, mitral, or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
  • Active endocarditis or infection within 3 months of scheduled implant procedure
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

St. Paul's Hospital, Providence Health Care Research Institute

Vancouver, British Columbia, V6E 1M7, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval

Québec, G1V 4G5, Canada

Location

Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

Hōpital Charles Nicolle

Rouen, 76031, France

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Charite-Universitätsmedzin Berlin

Berlin, 10117, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Munich University Clinic, Ludwig-Maximilian University

Munich, 81377, Germany

Location

Hygeia Hospital

Athens, 15123, Greece

Location

Inselspital, Universitätsspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Ted Feldman, MD
Organization
Edwards Lifesciences
Feldman_Info@edwards.com
949-250-2500

Publication Agreements

PI is Sponsor Employee
No
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

April 11, 2016

First Posted

June 1, 2016

Study Start

September 14, 2016

Primary Completion

January 30, 2018

Study Completion

December 14, 2020

Last Updated

October 25, 2022

Results First Posted

October 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)DE(4)FR(2)GR(1)CH(1)