Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

NCT05261204 | Enrolling By Invitation

• 1 other identifier: CN-22-25
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

The mechanical intervention is treating aortic valve stenosis (AVS) which may be performed using the standard open surgical approach for aortic valve replacement (AVR) or transcatheter aortic valve implantation (TAVI). The key question of this study is to establish the difference in all-cause and cause-specific (cardiac vs noncardiac) mortality, all hospitalizations for heart failure within 24 months of follow-up, left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-diastolic volume (LVEDV), in patients who received the TAVI vs the standard surgical procedure for AVS.

Conditions

Prosthesis Survival; Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Outcome Measures

Primary Outcomes (2)

• Treatment failure

  The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation

  5 years

• Hospitalizations for Heart Failure (HF)

  The secondary endpoint of the study is the evaluation of hospedalization rates for heart failure valve due to structural/ non structural valve deterioration, thromboembolism and recurrent endocarditis

  5 yeras

Secondary Outcomes (7)

• Overall Mortality

  5 years

• Cardiac Death

  5 years

• Non Cardiac Death

  5 years

• Major Adverse Cardiac or Cerebrovascular Events (MACCE)

  5 years

• Echocardiographic Parameter Changes (LVEF)

  5 years

Study Arms (3)

Transcatheter Aortic Valve Implantation

Patients with aortic-valve stenosis at risk to severe valve obstruction who received TAVI with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Device: Transcatheter Aortic Valve Implantation; Procedure: Bioprothesis; Procedure: Sutureless

Bioprosthesis

Patients with aortic-valve stenosis at risk to severe valve obstruction who undervent SAVR with the use of bioprosthesis with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Device: Transcatheter Aortic Valve Implantation; Procedure: Bioprothesis; Procedure: Sutureless

Sutureless

Patients with aortic-valve stenosis at risk to severe valve obstruction who were managed by mean of SAVR with the use of sutureless with or without CABG or PCI. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, aortic valve stenosis, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Device: Transcatheter Aortic Valve Implantation; Procedure: Bioprothesis; Procedure: Sutureless

Interventions

Transcatheter Aortic Valve Implantation DEVICE

Patients who are deemed receive TAVI first underwent evaluation of their peripheral arteries before the procedure, in order to separate those eligible for transfemoral placement (TFP) from those who would require transapical placement. Technological advances achieved in the new platforms for the treatment of SHD have allowed the use of reduced size catheters and sheaths in the new armamentarium, favoring the TFP technique. The transcatheter valve (TV) is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ventricular pacing. The delivery system i traverses the aorta retrograde over a guidewire from its point of insertion in the femoral artery during the use of TFP. Before balloon inflation, the valve and balloon are collapsed on the catheter and fit within the sheath. After balloon inflation, the calcified native valve is replaced by the expanded TV

Also known as: Transcatheter Aortic Valve Repacement

Bioprosthesis; Sutureless; Transcatheter Aortic Valve Implantation

Bioprothesis PROCEDURE

The bioprosthesis is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

Also known as: SAVR

Bioprosthesis; Sutureless; Transcatheter Aortic Valve Implantation

Sutureless PROCEDURE

The sutureless is implanted using the SAVR procedure during median sternotomy in extracorporeal circulation. Minimally invasive procedures using a thoracotomy approach and peripheral cannulation have found widespread use.

Also known as: SAVR

Bioprosthesis; Sutureless; Transcatheter Aortic Valve Implantation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with aortic valve stenosis with or without CAD who were symptomatic of congestive heart failure and unresponsive to medical therapy and who were eligible for mechanical intervention performed with the use of TAVI procedure or surgical aortic valve replacement. The severity of AVS was assessed by transthoracic echocardiography, performed using the European Society of Echocardiography criteria.

You may qualify if:

• Individuals enrolled in TAVI arm were required to have the predicted risk of operative mortality was ≥ 15% and/or a STS score of ≥ 10. A candidate who did not meet the STS score criteria of ≥ 10 was included in the study if a peer review by at least two surgeon investigators concluded and documented that the patient's predicted risk of operative mortality was ≥ 15%. For all group Senile degenerative aortic valve stenosis with echocardiography derived criteria: mean gradient \> 40 mm Hg or jet velocity \> 4.0 m/s or an aortic valve area (AVA) of \< 0.8 cm2 (or AVA index \< 0.5 cm2/m2).

You may not qualify if:

• Patients with evidence of an acute myocardial infarction ≤ 1 month before the intended treatment (defined as Q wave MI, or non-Q wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin level elevation.
• Blood dyscrasias as defined : leukopenia (WBC \< 3000 mm3), acute anemia (Hb \< 9 mg%), thrombocytopenia (platelet count \< 50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
• Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support devices
• Need for emergency surgery for any reason.
• Hypertrophic cardiomyopathy with or without obstruction.
• Severe ventricular dysfunction with LVEF \< 20%.
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
• Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel
• (Plavix), or sensitivity to contrast media, which cannot be adequately pre-medicated.
• For TAVI arm Native aortic annulus size \< 18mm or 25mm as measured by echocardiogram.
• Subject was offered surgery but refused surgery.
• Recent (within 6 months) cerebrovascular accident or transient ischemic attack.
• Renal insufficiency (creatinine \> 3.0mg/dL) and/or end stage renal disease requiring chronic
• dialysis.

Sponsors & Collaborators

• Centre Cardiologique du Nord: lead
• Henri Mondor University Hospital: collaborator
• Universita degli Studi di Genova: collaborator

Study Sites (1)

Francesco Nappi

Saint-Denis, 93200, France

Location

Related Publications (1)

• Nappi F, Bourgois C, Nenna A, Salsano A, Schoell T, El-Dean Z, Fiore A, Spadaccio C. Study protocol for an internahaational prospective non-randomised trial evaluating the long-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement for aortic-valve stenosis in patients at risk to severe valve obstruction: the TAVISAR trial. BMJ Open. 2025 May 24;15(5):e101417. doi: 10.1136/bmjopen-2025-101417.

  PMID: 40413055 DERIVED

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Transcatheter Aortic Valve Replacement; Sutureless Surgical Procedures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Wound Closure Techniques

Study Officials

• Francesco Nappi

  Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2022
• First Posted: March 2, 2022
• Study Start: January 1, 2013
• Primary Completion: May 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)