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The TransCatheter Valve and Vessels Trial (TCW)

Primary Purpose

Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FFR-guided PCI and TAVI
CABG and SAVR
Sponsored by
Maatschap Cardiologie Zwolle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic Stenosis (AS), Multi Vessel Coronary Artery Disease (MVD), TransCatheter Aortic Valve Implantation (TAVI), Coronary Artery By-pass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Fractional Flow Reserve (FFR), Surgical Aortic Valve Replacement (SAVR)

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity >4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team)
  2. Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision)
  3. Patients willing and capable to provide written informed consent

Exclusion Criteria:

  1. Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics <48 hours before procedure
  2. Left ventricular ejection fraction <30%
  3. Concomitant presence of other than aortic valve disease requiring intervention
  4. Previous CABG, SAVR, TAVI or thoracotomy for any other reason
  5. Bicuspid or unicuspid aortic valve
  6. Recent myocardial infarction (less than 2 weeks)
  7. Involvement of left main trifurcation (all three branches being larger than 2 mm)
  8. Expected total stent length more 60mm per vessel
  9. FFR measurement judged impossible
  10. Life expectancy <1 year
  11. Known malignancy
  12. Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months
  13. Reduced renal function (Glomerular Filtration Rate (GFR) <29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
  14. Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries
  15. Participation in other investigational clinical trials

Sites / Locations

  • Medical University of GrazRecruiting
  • General Hospital ViennaRecruiting
  • Rigshospitalet, Copenhagen University HospitalRecruiting
  • CHU de BordeauxRecruiting
  • CHRU de LilleRecruiting
  • Clinique Pasteur
  • University Hospital Frankfurt - Goethe University
  • Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbHRecruiting
  • Onassis Cardiac Surgery CenterRecruiting
  • OLVGRecruiting
  • HagaziekenhuisRecruiting
  • UMCG
  • Medisch Centrum Leeuwarden
  • St. Antonius hospitalRecruiting
  • RadboudumcRecruiting
  • HagaZiekenhuisRecruiting
  • Isala hospitalRecruiting
  • Medical University of Silesia
  • University hospital Opole
  • Hospital de Santa CruzRecruiting
  • SUSCCHRecruiting
  • Hospital Clinico Universitario San CarlosRecruiting
  • Hospital Clínico ValladolidRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FFR-guided PCI and TAVI

CABG and SAVR

Arm Description

FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO

CABG and SAVR

Outcomes

Primary Outcome Measures

The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year

Secondary Outcome Measures

Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year
All-cause mortality and all stroke at 30 days and at one year
Life-threatening or disabling bleeding at 30 days and one year
Life-threatening or disabling bleeding and major bleeding at 30 days and at one year
Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year
Access-related complications at 30 days
Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year
Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year
Device success (Valve Academic Research Consortium (VARC) 2 definition)
Early Safety at 30 days (VARC 2 definition)
Early Efficacy at 30 days (VARC 2 definition)
Time Related Valve Safety at 30 days (VARC 2 definition)
Echocardiographic assessment of prosthetic valve performance at discharge and at one year using the following measures: a) transvalvular mean gradient, b) Effective Orifice Area (EOA), c) degree of prosthetic aortic valve regurgitation
Clinically driven revascularisation at 30 days and at one year
Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year
Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year
Quality of life (Short Form (SF)-36) before treatment and at one year

Full Information

First Posted
January 9, 2018
Last Updated
July 8, 2022
Sponsor
Maatschap Cardiologie Zwolle
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT03424941
Brief Title
The TransCatheter Valve and Vessels Trial
Acronym
TCW
Official Title
TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients With Coronary MultiVessel Disease and Aortic Valve Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maatschap Cardiologie Zwolle
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.
Detailed Description
Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR. Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG, PCI, Fractional Flow Reserve
Keywords
Aortic Stenosis (AS), Multi Vessel Coronary Artery Disease (MVD), TransCatheter Aortic Valve Implantation (TAVI), Coronary Artery By-pass Grafting (CABG), Percutaneous Coronary Intervention (PCI), Fractional Flow Reserve (FFR), Surgical Aortic Valve Replacement (SAVR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
328 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFR-guided PCI and TAVI
Arm Type
Experimental
Arm Description
FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO
Arm Title
CABG and SAVR
Arm Type
Active Comparator
Arm Description
CABG and SAVR
Intervention Type
Device
Intervention Name(s)
FFR-guided PCI and TAVI
Intervention Description
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for FFR-guided PCI and TAVI (Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO)
Intervention Type
Device
Intervention Name(s)
CABG and SAVR
Intervention Description
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR
Primary Outcome Measure Information:
Title
The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year
Time Frame
one year
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year
Time Frame
one year
Title
All-cause mortality and all stroke at 30 days and at one year
Time Frame
30 days and one year
Title
Life-threatening or disabling bleeding at 30 days and one year
Time Frame
30 days and one year
Title
Life-threatening or disabling bleeding and major bleeding at 30 days and at one year
Time Frame
30 days and one year
Title
Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year
Time Frame
30 days and one year
Title
Access-related complications at 30 days
Time Frame
30 days
Title
Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year
Time Frame
30 days and one year
Title
Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year
Time Frame
30 days and one year
Title
Device success (Valve Academic Research Consortium (VARC) 2 definition)
Time Frame
procedure
Title
Early Safety at 30 days (VARC 2 definition)
Time Frame
30 days
Title
Early Efficacy at 30 days (VARC 2 definition)
Time Frame
30 days
Title
Time Related Valve Safety at 30 days (VARC 2 definition)
Time Frame
30 days
Title
Echocardiographic assessment of prosthetic valve performance at discharge and at one year using the following measures: a) transvalvular mean gradient, b) Effective Orifice Area (EOA), c) degree of prosthetic aortic valve regurgitation
Time Frame
discharge and at one year
Title
Clinically driven revascularisation at 30 days and at one year
Time Frame
30 days and one year
Title
Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year
Time Frame
30 days and one year
Title
Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year
Time Frame
30 days and one year
Title
Quality of life (Short Form (SF)-36) before treatment and at one year
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity >4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team) Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision) Patients willing and capable to provide written informed consent Exclusion Criteria: Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics <48 hours before procedure Left ventricular ejection fraction <30% Concomitant presence of other than aortic valve disease requiring intervention Previous CABG, SAVR, TAVI or thoracotomy for any other reason Bicuspid or unicuspid aortic valve Recent myocardial infarction (less than 2 weeks) Involvement of left main trifurcation (all three branches being larger than 2 mm) Expected total stent length more 60mm per vessel FFR measurement judged impossible Life expectancy <1 year Known malignancy Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months Reduced renal function (Glomerular Filtration Rate (GFR) <29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5) Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries Participation in other investigational clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Postma, PhD
Phone
+31 384262999
Email
TCW.trial@diagram-zwolle.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
prof. Elvin Kedhi, MD, PhD
Organizational Affiliation
Hopital Erasme, Brussels, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabor Toth, MD, PhD
Facility Name
General Hospital Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Martin Andreas, MD, PhD
Facility Name
Rigshospitalet, Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Thomas Engstrøm, MD PhD
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
G Bonnet, MD, PhD
Facility Name
CHRU de Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Eric Van Belle, MD, PhD
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Individual Site Status
Terminated
Facility Name
University Hospital Frankfurt - Goethe University
City
Frankfurt
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Lenard Conradi, MD
Facility Name
Onassis Cardiac Surgery Center
City
Kallithéa
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vassilis Voudris, MD, PhD
Facility Name
OLVG
City
Amsterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Amoroso, MD, PhD
Facility Name
Hagaziekenhuis
City
Den Haag
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samer Somi, MD, PhD
Facility Name
UMCG
City
Groningen
Country
Netherlands
Individual Site Status
Terminated
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
St. Antonius hospital
City
Nieuwegein
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Jurriën Ten Berg, MD, PhD
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen Van Wely, MD
Facility Name
HagaZiekenhuis
City
The Hague
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samer Somi, MD PhD
Facility Name
Isala hospital
City
Zwolle
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rik S. Hermanides, MD PhD
Facility Name
Medical University of Silesia
City
Katowice
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W. Wojakowski, MD, PhD
Facility Name
University hospital Opole
City
Opole
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Sacha, MD, PhD
Facility Name
Hospital de Santa Cruz
City
Lisboa
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Teles, MD, PhD
Facility Name
SUSCCH
City
Banská Bystrica
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hudec, MD, PhD
Facility Name
Hospital Clinico Universitario San Carlos
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Nombela-Franco, MD, PhD
Facility Name
Hospital Clínico Valladolid
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ignacio Amat, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The TransCatheter Valve and Vessels Trial

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