The TransCatheter Valve and Vessels Trial

Aortic Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03424941
• Other study ID #: 9283
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2018
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: Maatschap Cardiologie Zwolle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 172
• Est. completion date: November 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• CABG
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Fractional Flow Reserve
• Multi Vessel Coronary Artery Disease
• Myocardial Ischemia
• PCI
• TAVI

Intervention

Device:
• FFR-guided PCI and TAVI
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)
• CABG and SAVR
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Austria	General Hospital Vienna	Vienna
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen
France	CHU de Bordeaux	Bordeaux
France	CHRU de Lille	Lille
France	Clinique Pasteur	Toulouse
Germany	Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH	Hamburg
Greece	Onassis Cardiac Surgery Center	Kallithéa
Netherlands	OLVG	Amsterdam
Netherlands	Hagaziekenhuis	Den Haag
Netherlands	UMCG	Groningen
Netherlands	St. Antonius hospital	Nieuwegein
Netherlands	Radboudumc	Nijmegen
Netherlands	HagaZiekenhuis	The Hague
Netherlands	Isala hospital	Zwolle
Poland	Medical University of Silesia	Katowice
Poland	University hospital Opole	Opole
Portugal	Hospital de Santa Cruz	Lisboa
Slovakia	SUSCCH	Banská Bystrica
Spain	Hospital Clinico Universitario San Carlos	Madrid
Spain	Hospital Clínico Valladolid	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Maatschap Cardiologie Zwolle	Medtronic

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Greece,  Netherlands,  Poland,  Portugal,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one year
Secondary	Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year		one year
Secondary	All-cause mortality and all stroke at 30 days and at one year		30 days and one year
Secondary	Life-threatening or disabling bleeding at 30 days and one year		30 days and one year
Secondary	Life-threatening or disabling bleeding and major bleeding at 30 days and at one year		30 days and one year
Secondary	Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year		30 days and one year
Secondary	Access-related complications at 30 days		30 days
Secondary	Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year		30 days and one year
Secondary	Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year		30 days and one year
Secondary	Device success (Valve Academic Research Consortium (VARC) 2 definition)		procedure
Secondary	Early Safety at 30 days (VARC 2 definition)		30 days
Secondary	Early Efficacy at 30 days (VARC 2 definition)		30 days
Secondary	Time Related Valve Safety at 30 days (VARC 2 definition)		30 days
Secondary	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		discharge and at one year
Secondary	Clinically driven revascularisation at 30 days and at one year		30 days and one year
Secondary	Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year		30 days and one year
Secondary	Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year		30 days and one year
Secondary	Quality of life (Short Form (SF)-36) before treatment and at one year		one year