Back to resultsTRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial (TRACS)
Primary Purpose
Aortic Stenosis, Severe
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TAVI WITHOUT ON-SITE SURGERY
TAVI WITH ON-SITE SURGERY
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Stenosis, Severe
Eligibility Criteria
Inclusion Criteria: Severe aortic stenosis Indication to TAVI confirmed by the Study Heart Team AND one of the following: Inoperable due to prohibitive operative risk High surgical risk as defined as STS score >8% The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery: Porcelain aorta or severely atherosclerotic aorta Frailty/Reduced physical performance Cognitive impairment, dementia, or Parkinson's disease Severe liver disease/cirrhosis Hostile chest Internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum Severe pulmonary hypertension and/or severe right ventricular dysfunction Severe Chronic Obstructive Pulmonary Disease (COPD) Age ≥85 years Exclusion Criteria: Unsuitable for transfemoral TAVI Emergent TAVI Noncardiovascular comorbidity reducing life expectancy to <1 year Any factor precluding 1-year follow-up Refusal informed consent
Sites / Locations
- Azienda Unità Sanitaria LocaleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY
CONTROL ARM: TAVI WITH ON-SITE SURGERY
Arm Description
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI within 7-10 days in their hospital without on-site surgery
After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter
Outcomes
Primary Outcome Measures
Primary efficacy endpoint
1-year cumulative occurrence of all-cause death, stroke and hospital readmission for CV cause To test if the outcome of TAVI procedures performed by experienced operators in the center without onsite cardiac surgery is non inferior to that of TAVI procedures performed by the same team in the center with on-site cardiac surgery
Primary safety endpoint
To test whether mortality due to periprocedural complications actionable by emergent cardiac surgery differs between the TAVI procedures performed in the center without on-site cardiac surgery and the TAVI procedures performed by the same team in the center with on-site cardiac surgery
Secondary Outcome Measures
Secondary efficacy endpoints
All-cause death Cardiovascular death Myocardial infarction Hospital admission for cardiovascular cause Hospital admission for heart failure Cerebrovascular accident Ischemic stroke Hospital admission for pneumonia (± respiratory failure) Need for balloon aortic valvuloplasty for emergent condition Quality of life measured with the Eq-5D and KCCQ-12 scales Time spent on the waiting list before TAVI
Other safety endpoints
Cardiac tamponade Bleeding Kidney failure (requirement for renal replacement therapy) Severe aortic regurgitation (aortic regurgitation according to current guidelines) Multiorgan failure (failure of at least two organ systems) Vascular access site and access related complications Conduction disturbances and arrhythmias Endocarditis Valve thrombosis Valve malpositioning Valve embolization Ectopic valve deployment TAV-in-TAV deployment
Full Information
NCT ID
NCT05751577
First Posted
February 21, 2023
Last Updated
May 9, 2023
Sponsor
Azienda Usl di Bologna
Collaborators
Azienda Ospedaliero Universitaria di Ferrara, Azienda Ospedaliera di Reggio Emilia, Università degli Studi di Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT05751577
Brief Title
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Acronym
TRACS
Official Title
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 1, 2026 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Usl di Bologna
Collaborators
Azienda Ospedaliero Universitaria di Ferrara, Azienda Ospedaliera di Reggio Emilia, Università degli Studi di Ferrara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.
Detailed Description
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE). The TRACS trial will involve centers without on-site cardiac surgery, but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery. Thus, participating centers and their study TAVI operators must follow selective criteria for eligibility. Participants will be recruited after Heart Team indication to TAVI procedure. The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team. Study patients will be randomized in a 2:1 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Severe
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
TRACS is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (PROBE)
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL ARM: TAVI WITHOUT ON-SITE SURGERY
Arm Type
Experimental
Arm Description
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI within 7-10 days in their hospital without on-site surgery
Arm Title
CONTROL ARM: TAVI WITH ON-SITE SURGERY
Arm Type
Active Comparator
Arm Description
After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter
Intervention Type
Procedure
Intervention Name(s)
TAVI WITHOUT ON-SITE SURGERY
Intervention Description
After randomization, study TAVI operators of the participating center will schedule the patient for TAVI within 7-10 days in their hospital without on-site surgery
Intervention Type
Procedure
Intervention Name(s)
TAVI WITH ON-SITE SURGERY
Intervention Description
After randomization, the patient will immediately be placed on the waiting list of the referring center with on-site cardiac surgery. Study TAVI operators of the participating center will perform the TAVI procedure in the hospital with on-site surgery according to the waiting list schedule of the latter
Primary Outcome Measure Information:
Title
Primary efficacy endpoint
Description
1-year cumulative occurrence of all-cause death, stroke and hospital readmission for CV cause To test if the outcome of TAVI procedures performed by experienced operators in the center without onsite cardiac surgery is non inferior to that of TAVI procedures performed by the same team in the center with on-site cardiac surgery
Time Frame
1-year
Title
Primary safety endpoint
Description
To test whether mortality due to periprocedural complications actionable by emergent cardiac surgery differs between the TAVI procedures performed in the center without on-site cardiac surgery and the TAVI procedures performed by the same team in the center with on-site cardiac surgery
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Secondary efficacy endpoints
Description
All-cause death Cardiovascular death Myocardial infarction Hospital admission for cardiovascular cause Hospital admission for heart failure Cerebrovascular accident Ischemic stroke Hospital admission for pneumonia (± respiratory failure) Need for balloon aortic valvuloplasty for emergent condition Quality of life measured with the Eq-5D and KCCQ-12 scales Time spent on the waiting list before TAVI
Time Frame
1-year
Title
Other safety endpoints
Description
Cardiac tamponade Bleeding Kidney failure (requirement for renal replacement therapy) Severe aortic regurgitation (aortic regurgitation according to current guidelines) Multiorgan failure (failure of at least two organ systems) Vascular access site and access related complications Conduction disturbances and arrhythmias Endocarditis Valve thrombosis Valve malpositioning Valve embolization Ectopic valve deployment TAV-in-TAV deployment
Time Frame
1-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe aortic stenosis
Indication to TAVI confirmed by the Study Heart Team
AND one of the following:
Inoperable due to prohibitive operative risk
High surgical risk as defined as STS score >8%
The presence of at least one clinical factor that, by unanimous judgment of the Study Heart Team, compromises the benefit/risk ratio in the case of emergent cardiac surgery:
Porcelain aorta or severely atherosclerotic aorta
Frailty/Reduced physical performance
Cognitive impairment, dementia, or Parkinson's disease
Severe liver disease/cirrhosis
Hostile chest
Internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum
Severe pulmonary hypertension and/or severe right ventricular dysfunction
Severe Chronic Obstructive Pulmonary Disease (COPD)
Age ≥85 years
Exclusion Criteria:
Unsuitable for transfemoral TAVI
Emergent TAVI
Noncardiovascular comorbidity reducing life expectancy to <1 year
Any factor precluding 1-year follow-up
Refusal informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianmarco Iannopollo, Md
Phone
0513138704
Email
gianmarco.iannopollo@ausl.bologna.it
Facility Information:
Facility Name
Azienda Unità Sanitaria Locale
City
Bologna
ZIP/Postal Code
40100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianmarco Iannopollo, Md
Phone
0513138704
Email
gianmarco.iannopollo@ausl.bologna.it
First Name & Middle Initial & Last Name & Degree
Gianmarco Iannopollo, Md
First Name & Middle Initial & Last Name & Degree
Gianni Casella, Md
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial
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