Transcatheter Aortic Valve ImplantationFOLLOWNCT03613246
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
An observational study of Transcatheter Aortic Valve Implantation, run by NVT GmbH at 14 sites in 6 countries.
Trial summary
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Implantation
- How many people
- 346 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 20 Feb 2019to 26 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.
Who may be able to join
- Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve
- Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use)
- High risk for surgery as assessed by the heart team
- Has signed the Patient Informed Consent Form >= 18 years
Who cannot join
- General:
- Echocardiographic evidence of intracardiac thrombus or vegetation
- Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF
- Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible
- Severe ventricular dysfunction with LVEF <20%
- Evidence of active endocarditis or other acute infections
Show all 19Show fewer
- Renal failure requiring continuous renal replacement therapy
- Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to nitinol alloy or to bovine tissue
- Life expectancy ≤ 12 months due to other medical illness
- Currently participating in another investigational drug or device study
- Patients with native aortic valve disease:
- Unicuspid or bicuspid aortic valve
- Non-calcified aortic stenosis
- Combined aortic valve disease with predominant aortic regurgitation > 3
- Distance between aortic valve basal plane and the orifice of the lowest coronary artery < 8 mm
- Patients with degenerated surgical bioprosthetic aortic valves:
- Low position of the coronary ostia, especially in combination with shallow sinuses
- Internal diameter of the bioprosthesis is ≤16 mm or >28 mm
- Partially detached leaflets that in the aortic position may obstruct a coronary ostium
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Germany5 sites
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, 29549
Schuechtermann-klinik
Bad Rothenfelde
Kath. Marienkrankenhaus
Hamburg, 22087
MH Hannover
Hanover, 30625
SLK-Kliniken Heilbronn
Heilbronn, 74078
Spain4 sites
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Alvaro Cunqueiro
Vigo, 36213
Italy2 sites
Ospedale San Raffaele
Milan, 20132
Clinica Mediterranea Neapel
Naples
Netherlands1 site
Heartcentre Catharina Hospital Eindhoven
Eindhoven, 5623 EJ
About this study
Official title: Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population With Elevated Surgical Risk
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Conditions
- Transcatheter Aortic Valve Implantation
- Keywords
- TAVI, Aortic valve stenosis, ALLEGRA
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Patients who undergo TAVI for symptomatic severe stenosed aortic heart valves | Not described | |
| Cohort 2: | patients undergoing a VIV procedure in failing surgical bioprostheses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
Measured: 30 days post-index procedure
Secondary outcomes (8)
All-cause mortality
Measured: up to five years
Technical success of implantation
Technical success of implantation, as defined by:
- absence of procedural mortality AND
- correct positioning of a single prosthetic heart valve into the proper anatomical location AND
- no prosthesis - patient mismatch AND
- mean aortic valve gradient <20 mmHg, AND
- no moderate or severe prosthetic valve regurgitation
Measured: day of procedure
Assesment of NYHA classification
Measured: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
Safety profile according to VARC II
Early Safety
- All-cause mortality
- All stroke (disabling and non-disabling)
- Life-threatening bleeding
- Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
- Coronary artery obstruction requiring intervention
- Major vascular complication
- Valve-related dysfunction requiring repeat procedure
Time-related valve safety
- Structural valve deterioration as defined by
- Requiring repeat procedure (transcatheter or surgical heart valve replacement)
- Valve-related dysfunction defined by
- mean aortic valve gradient ≥20 mmHg and
- no moderate or severe prosthetic valve regurgitation
- Prosthetic valve endocarditis
- Prosthetic valve thrombosis
- Thrombo-embolic events (e.g. stroke)
- VARC bleeding, unless clearly unrelated to valve therapy
Measured: 30 days
In-hospital mortality
Measured: date of procedure till date of estimated discharge, assessed up to two weeks
Quality of life (EQ5D 5L)
Measured: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
New pacemaker implantation
Measured: up to five years
assessment of mean aortic gradient post-implantation
Measured: up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start20 Feb 2019
- Primary completion20 Dec 2024
- Study completion26 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- NVT GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulrich Schäfer, MD, Principal investigator, Herz-und Gefäßzentrum Bad Bevensen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613246
- Sponsor's protocol ID
- NVT04FOL
- Acronym
- FOLLOW
- Status last verified
- Nov 2025
- First submitted
- 6 Jul 2018
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of the NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population With Elevated Surgical Risk
- ClinicalTrials.gov ID
- NCT03613246
- Acronym / sponsor ID
- FOLLOW / NVT04FOL
- Conditions
- Transcatheter Aortic Valve Implantation
- Keywords
- TAVI, Aortic valve stenosis, ALLEGRA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 346 participants (actual)
- Lead sponsor
- NVT GmbHIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 26 Jan 2029 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Patients who undergo TAVI for symptomatic severe stenosed aortic heart valves | – | – |
| Cohort 2: | – | –patients undergoing a VIV procedure in failing surgical bioprostheses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic patients with elevated surgical risk and candidate for TAVI with severe calcified and stenotic aortic valves or failing surgical bioprosthetic aortic valves.
Key inclusion criteria (4 listed)
- Symptomatic degeneration of severe calcified aortic heart valve OR failing surgical aortic bioprosthetic valve
- Acceptable candidate for elective treatment with the ALLEGRA TAVI System TF (according to the most recent version of the ALLEGRA Instructions For Use)
- High risk for surgery as assessed by the heart team
- Has signed the Patient Informed Consent Form >= 18 years
Key exclusion criteria (19 listed)
- Echocardiographic evidence of intracardiac thrombus or vegetation
- Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF
- Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible
- Severe ventricular dysfunction with LVEF <20%
- Evidence of active endocarditis or other acute infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular death
Time frame: 30 days post-index procedure
8 secondary outcomes
All-cause mortality
Time frame: up to five years
Technical success of implantation
Time frame: day of procedure
Assesment of NYHA classification
Time frame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
Safety profile according to VARC II
Time frame: 30 days
In-hospital mortality
Time frame: date of procedure till date of estimated discharge, assessed up to two weeks
Quality of life (EQ5D 5L)
Time frame: 30 days, 12 month, 24 month, 36 month, 48 month, 60 month
New pacemaker implantation
Time frame: up to five years
assessment of mean aortic gradient post-implantation
Time frame: up to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Transcatheter Aortic Valve Implantation
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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
RecruitingObservational study
Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis.
Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Schäfer, MD principal investigator
Herz-und Gefäßzentrum Bad Bevensen, Germany
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation, run by NVT GmbH at 14 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Spain, Italy, Finland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death (time frame: 30 days post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.