RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation

NCT05036018 | Active Not Recruiting DMC

• 1 other identifier: 2021-0165
• Study Type: interventional
• Target: 836
• Locations: 1 country
• Sites: 10

Brief Summary

Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.

Conditions

Aortic Valve Stenosis

Keywords

TAVI; ACURATE neo2; Evolut Pro; local anesthesia; conscious sedation; monitored anesthesia care; minimalist approach

Outcome Measures

Primary Outcomes (2)

• Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up

  Day 30

• Strategy: composite of all-cause mortality vascular complications (major + minor according to VARC-3), bleeding complications (type 1-4 according to VARC-3), infections requiring antibiotic treatment, and neurologic events (NeuroARC type 1-3)

  Day 30

Study Arms (4)

Group 1

ACTIVE COMPARATOR

Patients treated with the ACURATE neo2 valve using a minimalist approach

Device: ACURATE neo2; Procedure: minimalist approach

Group 2

ACTIVE COMPARATOR

Patients treated with the ACURATE neo2 valve under standard of care

Device: ACURATE neo2; Procedure: Standard of care

Group 3

ACTIVE COMPARATOR

Patients treated with the Evolut Pro, Pro+ or FX valve using a minimalist approach

Procedure: minimalist approach; Device: CoreValve Evolut Pro, Pro+ and FX

Group 4

ACTIVE COMPARATOR

Patients treated with the Evolut Pro, Pro+ or FX valve under standard of care

Device: CoreValve Evolut Pro, Pro+ and FX; Procedure: Standard of care

Interventions

ACURATE neo2 DEVICE

The ACURATE neo2 valve will be implanted using a two-step mechanism during transfemoral transcatheter aortic valve implantation (TAVI). Balloon predilatation will be recommended in the ACURATE neo 2 valve group.

Group 1; Group 2

minimalist approach PROCEDURE

Isolated local anesthesia. Central venous lines, additional arterial lines for blood pressure monitoring, and urinary catheters will be avoided. Insertion of temporary pacemakers is optional and should be avoided whenever possible, and peri-procedural pacing can then be performed on the left ventricular wire. Patients will be directly transferred to the cardiology ward after the procedure, which can be postponed in case of complications.

Group 1; Group 3

CoreValve Evolut Pro, Pro+ and FX DEVICE

The Evolut Pro, Pro+ or FX valve is positioned in a controlled manner either without pacing or under 'slow-rapid' pacing with allowance for limited repositioning and is anchored to the annulus and ascending aorta.

Group 3; Group 4

Standard of care PROCEDURE

Sedation should be titrated to a Richmond Agitation Sedation Scale (RASS) of 0 to -2 according to local standard of care.The use of EEG monitoring (i.e. BIS, Sedline) can be applied. Continuous CO2-monitoring via face mask should be established during sedation. All patients will receive supplemental oxygen by face mask to maintain an oxygen saturation of approximately 95%. The use of central venous catheters, additional arterial lines for blood pressure monitoring, and urinary catheters can be implemented according to local institutional standards.

Group 2; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
• Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
• Heart team consensus that the patient is anatomically suitable for both device types
• Suitability for transfemoral vascular access
• Written informed consent

You may not qualify if:

• Life expectancy \<12 months due to comorbidities
• Native aortic valve annulus \<21 mm and \>27 mm
• Bicuspid aortic valve
• Cardiogenic shock or hemodynamic instability
• Active endocarditis
• Contraindications for transfemoral access
• Active peptic ulcer or upper gastro-intestinal bleeding \<2 weeks
• Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
• Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team
• Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
• Active infection requiring antibiotic treatment
• Age \<18 years
• Participation in another interventional trial where the primary endpoint has not been reached

Sponsors & Collaborators

• Leipzig Heart Science gGmbH: lead
• Heart Center Leipzig - University Hospital: collaborator

Study Sites (10)

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

Location

Universitätsklinikum Köln

Cologne, 50937, Germany

Location

St.-Johannes-Hospital Dortmund

Dortmund, 44137, Germany

Location

Universitätsklinikum Gießen

Giessen, 35392, Germany

Location

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Leipzig, 04289, Germany

Location

Herzzentrum München

München, 80636, Germany

Location

LMU Klinikum München

München, 81377, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, 42283, Germany

Location

Related Publications (1)

• Feistritzer HJ, Ender J, Lauten P, Rudolph TK, Rudolph V, Geisler T, Massberg S, Adam M, Baldus S, Sossalla S, Joner M, Mollmann H, Wolf A, Kim WK, Borger MA, Noack T, Magunia H, von Dossow V, Sander M, Vigelius-Rauch U, Feuerecker M, Zakhary W, Boening A, Bleiziffer S, Hohenstein S, Hoesler N, Buske M, Desch S, Abdel-Wahab M, Thiele H; DOUBLE-CHOICE Investigators. Peri-Interventional Anesthesia Strategies for Transcatheter Aortic Valve Implantation: A Multicenter, Randomized, Controlled, Noninferiority Trial. Circulation. 2025 Dec 2;152(22):1526-1537. doi: 10.1161/CIRCULATIONAHA.125.076557. Epub 2025 Aug 29.

  PMID: 40878766 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Patient Reported Outcome Measures; Standard of Care

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Quality Indicators, Health Care

Study Officials

• Holger Thiele, Prof. Dr.

  Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of cardiologists, anesthesiologists and patients is not possible due to the type of interventions.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to one of four treatment groups in a 1:1:1:1 ratio

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 5, 2021
• Study Start: August 30, 2021
• Primary Completion: March 31, 2025
• Study Completion (Estimated): February 1, 2035
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)