EffecTAVI Registry

Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry

Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.

For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time.

This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVI
• Intervention / Treatment: Device: Transcatheter heart valve (THV) with CE approval

Detailed Description

Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears.

For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI.

This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.

EffectTAVI is an observational, monocentric registry promoted by Department of Advanced Biomedical Sciences of University of Naples Federico II.

The aim is to collect clinical, procedural, echocardiographic data and to evaluate the clinical outcomes of TAVI procedure.

Study population: consecutive patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to current guidelines recommendations.

Severe AS will be defined according to the following echocardiographic criteria:

• Aortic valve area: < 1 cm2
• Indexed aortic valve area: < 0,6 cm2/m2
• Mean aortic valve gradient: ≥ 40 mmHg
• Peak aortic jet velocity: ≥ 4,0 m/sec

TAVI can be performed using several arterial access: transfemoral, transapical, trans-subclavian and trans-aortic.

Written informed consent will be obtained for all patients for participation in this registry.

After hospital discharge, clinical follow-up will be performed at 30-day, 6 months and 1-year after TAVI. All adverse events were systematically collected and classified according to the definitions of the Valve Academic Research Consortium (VARC)-3 criteria.

Clinical, procedural and follow-up data will be anonymously entered in a web-based database RedCap (https://www.redcap.unina.it/redcap/). Patients will be entered with a pseudonym generated by the data collection system.

The pseudonym does not allow the identification of the patient and, therefore, meets the European criteria for the acquisition of data online.

The access to the online database is allowed through the use of a personal password, provided to the Primary Investigator and to the Co-Investigators involved in the study.

Data analysis will be performed by the investigators of the Department of Advanced Biomedical Sciences.

The extensive case studies that investigators expect to collect will be useful to establish clinical, procedural and follow-up data in short, medium and long term of patients with severe aortic stenosis undergoing TAVI.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Anna Franzone, MD, PhD; Phone Number: +390817464325; Email: anna.franzone@unina.it
• Study Contact Backup: Name: Giovanni Esposito, MD, PhD; Phone Number: +390817463075; Email: espogiov@unina.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Federico II University of Naples
    • Contact: Anna Franzone, MD,PhD; Phone Number: 0039 0817464325; Email: anna.franzone@unina.it
    • Contact: MD, PhD; Phone Number: 0039 0817464325; Email: anna.franzone@unina.it
    • Principal Investigator: Giovanni Esposito, MD, PhD
    • Principal Investigator: Anna Franzone, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic severe AS candidate to TAVI, established by the multi-disciplinary Heart Team according to the current guidelines.

Description

Inclusion Criteria:

1. Patients with symptomatic severe AS or degenerated bioprosthetic aortic valve and suitable for TAVI according to Heart Team evaluation;
2. Ability to provide informed consent.

Exclusion Criteria:

1. Contraindications to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis;
2. Poor adherence to scheduled follow-up;
3. Unable to understand and follow study-related instructions.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with symptomatic severe AS undergoing TAVI.	Device: Transcatheter heart valve (THV) with CE approval; TAVI trough femoral access or alternative routes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	All cause mortality	30 days
All cause mortality	All cause mortality	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	Cardiovascular mortality	30 days
Cardiovascular mortality	Cardiovascular mortality	1 year
Number of participants with neurological events	Neurological events	30 days
Number of participants with neurological events	Neurological events	1 year
Number of participants with bleeding events	Bleeding events	30 days
Number of participants with bleeding events	Bleeding events	1 year
Vascular and access-related complications	Vascular and access-related complications	30 days
Vascular and access-related complications	Vascular and access-related complications	1 year
Number of participants with new conduction disturbances and arrhythmias	New conduction disturbances and arrhythmias	30 days
Number of participants with new conduction disturbances and arrhythmias	New conduction disturbances and arrhythmias	1 year
Number of participants with acute kidney injury	Acute kidney injury	30 days
Number of participants with acute kidney injury	Acute kidney injury	1 year
Number of participants with myocardial infarction	Myocardial infarction	30 days
Number of participants with myocardial infarction	Myocardial infarction	1 year
Hospitalization or re-hospitalization	Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.	30 days
Hospitalization or re-hospitalization	Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.	1 year
Cardiac structural complications	Any cardiac structure occurring during the procedure involving the aortic annulus, left ventricle outflow tract, ventricular septum, left or right ventricle, left or right atrium, mitral valve apparatus, tricuspid valve apparatus, coronary sinus, and pericardial effusion.	30 days
Cardiac structural complications	Any cardiac structure occurring during the procedure involving the aortic annulus, left ventricle outflow tract, ventricular septum, left or right ventricle, left or right atrium, mitral valve apparatus, tricuspid valve apparatus, coronary sinus, and pericardial effusion.	1 year
Number of participants with bioprosthetic valve dysfunction	Bioprosthetic valve dysfunction	30 days
Number of participants with bioprosthetic valve dysfunction	Bioprosthetic valve dysfunction	1 year
Number of participants with leaflet thickening	Hypo-attenuated leaflet thickening (HALT)	30 days
Number of participants with leaflet thickening	Hypo-attenuated leaflet thickening (HALT)	1 year
Number of participants with leaflet reduced motion	Reduced leaflet motion (RLM)	30 days
Number of participants with leaflet reduced motion	Reduced leaflet motion (RLM)	1 year
Number of participants with clinically significant valve thrombosis	Clinically significant valve thrombosis	30 days
Number of participants with clinically significant valve thrombosis	Clinically significant valve thrombosis	1 year

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Giovanni Esposito, MD, PhD, Federico II University

Publications and helpful links

General Publications

• Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
• Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.
• Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchetche D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.
• VARC-3 WRITING COMMITTEE; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research. Eur Heart J. 2021 May 14;42(19):1825-1857. doi: 10.1093/eurheartj/ehaa799.
• Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;143(5):e35-e71. doi: 10.1161/CIR.0000000000000932. Epub 2020 Dec 17. Erratum In: Circulation. 2021 Feb 2;143(5):e228. Circulation. 2021 Mar 9;143(10):e784.
• Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Blanke P, Leipsic JA, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Herrmann HC, Szeto WY, Genereux P, Pershad A, Lu M, Webb JG, Smith CR, Pibarot P; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar 9;77(9):1149-1161. doi: 10.1016/j.jacc.2020.12.052.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 9, 2021
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVI
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: 231/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No