NCT04009434

Brief Summary

To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

3.7 years

First QC Date

July 3, 2019

Last Update Submit

February 3, 2020

Conditions

Aortic StenosisMitral Regurgitation

Keywords

Aortic StenosisAortic DiseaseTranscatheter Aortic Valve ImplantationMitral RegurgitationMitral Valve RegurgitationMitral DiseaseMitral valve clippingMitraClipHeart Valve Diseases

Outcome Measures

Primary Outcomes (1)

  • Death from any cause and heart failure hospitalization

    Composite endpoint of time to heart failure hospitalization or death from any cause

    1 year

Secondary Outcomes (5)

  • Death from any cause

    1, 2, 3, 4 years

  • Need for mitral valve reintervention

    1, 2, 3, 4 years

  • Mitral regurgitation severity

    1 year

  • 6 Minute Walk Test

    1 year

  • New York Heart Association Functional Class

    1, 3, 6 months and 1, 2, 3, 4 years

Other Outcomes (1)

  • Number of patients with AEs, SAEs.

    1, 2, 3, 4 years

Study Arms (2)

TAVI

OTHER

Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy

Device: TAVI

TAVI/MitraClip

EXPERIMENTAL

Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.

Device: Mitral Valve ClippingDevice: TAVI

Interventions

Mitral Valve ClippingDEVICE

Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.

TAVI/MitraClip
TAVIDEVICE

Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.

TAVITAVI/MitraClip

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
  • Moderate to severe mitral regurgitation
  • Symptom status NYHA II-III
  • Age ≥ 18 and \< 90 years
  • Written informed consent

You may not qualify if:

  • MR mechanism/anatomy precluding MitraClip therapy
  • Groin blood vessels are not eligible for TAVI procedure
  • Massive or torrential tricuspid regurgitation
  • Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
  • Life expectancy \< 1 year due to non-cardiac conditions
  • LVEF ≤ 25%
  • Hypotension (systolic pressure \< 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support
  • Cardiomyopathy other than dilated cardiomyopathy
  • Fixed pulmonary artery systolic pressure \> 70 mm Hg
  • Any prior mitral valve surgery or transcatheter mitral valve procedure
  • Stroke or transient ischemic event within 6 months prior to randomization
  • Severe symptomatic carotid stenosis
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart-Center Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Valve StenosisMitral Valve InsufficiencyAortic DiseasesDiseaseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Axel Linke, MD

    Technische Universitaet Dresden, HEART CENTER

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Linke, MD

CONTACT

+49 351 4501704mitavi@mailbox.tu-dresden.de

Stephan Haussig, MD

CONTACT

+49 351 4501704mitavi@mailbox.tu-dresden.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 5, 2019

Study Start

December 1, 2019

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

DE(1)