The TransCatheter Valve and Vessels Trial

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    328
  • sponsor
    Maatschap Cardiologie Zwolle
Updated on 11 April 2021
stenosis
stroke
myocardial infarction
infarct
coronary artery bypass graft
aortic valve replacement
transcatheter aortic valve implantation

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.

Details
Condition Coronary artery bypass graft, Aortic Stenosis, VALVULAR HEART DISEASE, Protein C Inhibitor, Percutaneous Coronary Intervention, Multi Vessel Coronary Artery Disease, Fractional Flow Reserve, TAVI, Heart Valve Disease, aortic valve stenosis, transcatheter aortic valve implant, cabg, coronary artery bypass, coronary bypass, coronary artery bypass surgery, prophylactic cranial irradiation
Treatment FFR-guided PCI and TAVI, CABG and SAVR
Clinical Study IdentifierNCT03424941
SponsorMaatschap Cardiologie Zwolle
Last Modified on11 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 70 yrs?
Gender: Male or Female
Do you have any of these conditions: Aortic Stenosis or Protein C Inhibitor or Coronary artery bypass graft or TAVI or Fractional Flow Reserve or Multi Vessel Coronary Artery Disease?
Do you have any of these conditions: Multi Vessel Coronary Artery Disease or transcatheter aortic valve implant or Aortic Stenosis or Percutaneous Coronary Intervention or Protein C Inhib...?
Do you have any of these conditions: Fractional Flow Reserve or prophylactic cranial irradiation or cabg or Aortic Stenosis or coronary artery bypass or coronary artery bypass surgery or ...?
Do you have any of these conditions: aortic valve stenosis or cabg or Aortic Stenosis or transcatheter aortic valve implant or prophylactic cranial irradiation or coronary artery bypass o...?
Do you have any of these conditions: prophylactic cranial irradiation or coronary artery bypass surgery or Coronary artery bypass graft or coronary bypass or TAVI or Aortic Stenosis or Pe...?
Do you have any of these conditions: VALVULAR HEART DISEASE or Heart Valve Disease or cabg or coronary bypass or aortic valve stenosis or TAVI or coronary artery bypass or Protein C Inhib...?
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
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