Atrial FibrillationAmulet™PMSNCT02447081
Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
An observational study of Atrial Fibrillation and Thromboembolism, run by Abbott Medical Devices at 51 sites in 16 countries.
Trial summary
This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Thromboembolism, Stroke
- What is being tested?
- Subjects implanted with Amulet Device
- Type of treatment
- Medical device
- How many people
- 1,088 participants
- Where
- 51 sitesin 16 countries
- Study dates
- 1 Jun 2015to 23 Oct 2018
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients with non-valvular atrial fibrillation
Who may be able to join
- Subject with history of paroxysmal, persistent or permanent NVAF
- Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
- Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
- Subject who is willing and capable of providing informed consent, participating in all associated study activities
Who cannot join
- Subject with evidence of an intracardiac thrombus
- Subject with active infection or active endocarditis or other infections producing bacteremia
- Subject where the placement of the device would interfere with any intracardiac or intravascular structures
- Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
- Subject with LAA anatomy that does not accommodate a device per the sizing guidelines
Trial locations and contacts
51 sites in 16 countries.
51 sites in 16 countries
Germany17 sites
Zentralklinik Bad Berka Gmbh
Bad Berka, Thuringia, 99437
Zentralklinik Bad Berka
Bad Berka
Segeberger Kliniken Gmbh
Bad Segeberg, 23795
Segeberger Kliniken GmbH
Bad Segeberg
Charité - Universitätsmedizin Berlin (CBF)
Berlin, 12203
St. Marien Hospital Bonn
Bonn, 53115
Klinikum Coburg
Coburg, Bavaria, 96450
Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt
Darmstadt, Hesse, 64287
Herzzentrum Dresden
Dresden
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphal, 40225
Cardioangiologisches Centrum Bethanien
Frankfurt, 60431
Klinikum Frankfurt Höchst
Frankfurt, 65929
CardioVaskuläres Centrum St. Katharinen
Frankfurt am Main, Hesse, 60389
Internistische Klinik Dr. Müller, München-Thalkirchen
Munich, Bavaria, 81379
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg
Universitaetsklinikum Ulm
Ulm, Bavaria, 89081
Rems-Murr-Klinikum Winnenden
Winnenden, 71364
Italy8 sites
Nuovo Ospedale Civile Sant'Agostino Estense
Baggiovara, Modena, 41126
Azienda Ospedaliera S. Anna e S. Sebastiano
Caserta, 81100
Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio
Massa
Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia
Mestre, Veneto, 30174
Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan
Milan
San Raffaele Hospital
Milan
Ospedale Luigi Sacco
Milan, 20157
Università degli Studi di Padova
Padova, Veneto, 35128
Spain6 sites
Hospital Universitario Infanta Cristina
Badajoz, Extremadura, 6080
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalonia, 08025
Hospital Clinic I Provincial de Barcelona
Barcelona, 8028
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Island, 07120
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41007
France4 sites
CHU d'Amiens
Amiens, Picardy, 80054
CHU du Bocage
Dijon, Burgundy, 21034
CHRU Lille
Lille, North-Calais, 59037
Hopital Haut Leveque
Pessac, Aquitaine, 33600
United Kingdom3 sites
The Royal Sussex Country Hospital
Brighton, South East England
Liverpool Heart and Chest Hospital
Liverpool, Northwest England
St Thomas Hospital
London, SE1 7EH
Finland2 sites
Helsinki University Central Hospital
Helsinki, Uusimaa
Turku University Hospital
Turku
Poland2 sites
Slaskie Centrum Chorob Serca
Warsaw, 01-785
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628
About this study
Official title: Amplatzer™Amulet™ Observational Post-Market Study
This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."
Read the detailed description
A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.
The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.
Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Being tested
- Subjects implanted with Amulet Device
- Medical subject headings
- Atrial Fibrillation, Thromboembolism, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjects implanted with Amulet DeviceDevice
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
| Study group | Role | What they receive |
|---|---|---|
| Subjects implanted with Amulet Device | All subjects who receive the Amulet device will be followed. Receives: Device: Subjects implanted with Amulet Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Acute Serious Adverse Events
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Measured: 0 to 7 days post procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Late adverse events were defined as those serious events with an onset date > 7 days post-procedure
Measured: 7 days through 2 years
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Measured: Implant through 2 years
Number of Participants With Major Bleeding Events
Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
Measured: Implant through 2 years
Secondary outcomes (7)
Number of Participants With Technical Success
Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).
Measured: During implant procedure, approximately 30 to 60 minutes
Number of Participants With Procedural Success
Procedural success is based on Amulet device being implanted day 0 through hospital discharge, on average one night stay (day 1). Amulet device implanted and subject discharged the following day without an adverse event
Measured: During the implant procedure and hospital stay, approximately 1 or 2 days
Number of Participants With Oral Anti-coagulation Usage
Measured: At discharge, approximately 1 or 2 days after the procedure
Number of Participants With Oral Anti-coagulation Usage
Measured: At 1 to 3 months
Number of Participants With Oral Anti-coagulation Usage
Measured: At 6 months
Number of Participants With Oral Anti-coagulation Usage
Measured: At 12 months
Number of Participants With Oral Anti-coagulation Usage
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study start1 Jun 2015
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- 1,088 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Hildick-Smith, MD, Principal investigator, Brighton and Sussex University HospitalsClaudio Tondo, MD PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447081
- Sponsor's protocol ID
- SJM-CIP-10053
- Acronym
- Amulet™PMS
- Status last verified
- Dec 2019
- First submitted
- 27 Apr 2015
- Last updated
- 30 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
De Caterina AR, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Fischer S, Lund J, Montorfano M, Gage R, Lam SCC, Berti S. Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer Amulet Observational Study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100848. doi: 10.1016/j.ijcha.2021.100848. eCollection 2021 Aug.
PubMed 34381870Piayda K, Hellhammer K, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Gage R, Zeus T. Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study. BMJ Open. 2021 Mar 24;11(3):e040455. doi: 10.1136/bmjopen-2020-040455.
PubMed 33762228Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Lam SCC, Freixa X, Gage R, Diener HC, Schmidt B. Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study. EuroIntervention. 2021 Oct 20;17(9):774-782. doi: 10.4244/EIJ-D-20-01309.
PubMed 33495144Tarantini G, D'Amico G, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Lam SCC, Cruz-Gonzalez I, Gage R, Zhao H, Omran H, Odenstedt J, Nielsen-Kudsk JE. The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study. JACC Cardiovasc Interv. 2020 Sep 28;13(18):2099-2108. doi: 10.1016/j.jcin.2020.06.003.
PubMed 32972570
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplatzer™Amulet™ Observational Post-Market Study
- ClinicalTrials.gov ID
- NCT02447081
- Acronym / sponsor ID
- Amulet™PMS / SJM-CIP-10053
- Conditions
- Atrial Fibrillation, Thromboembolism, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,088 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Posted 30 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."
Detailed description
A total of 1088 subjects were enrolled in the study at 61 sites internationally, outside the United States.
The study assessed acute and late serious adverse events and reports the rate of stroke and bleeding events through 2 years. No formal hypothesis were tested for this observational post-market study.
Each patient was followed at study visits at baseline, implant, 1-3 months, 6 months, 12 months, and 24 months post implant."
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects implanted with Amulet Device | – | Device: Subjects implanted with Amulet DeviceAll subjects who receive the Amulet device will be followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-valvular atrial fibrillation
Key inclusion criteria (4 listed)
- Subject with history of paroxysmal, persistent or permanent NVAF
- Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
- Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
- Subject who is willing and capable of providing informed consent, participating in all associated study activities
Key exclusion criteria (6 listed)
- Subject with evidence of an intracardiac thrombus
- Subject with active infection or active endocarditis or other infections producing bacteremia
- Subject where the placement of the device would interfere with any intracardiac or intravascular structures
- Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subjects implanted with Amulet DevicePercutaneous Left Atrial Appendage occlusion with successful implant of occlusion device. | Device | Subjects implanted with Amulet Device |
Primary outcome
Number of Participants With Acute Serious Adverse Events
Time frame: 0 to 7 days post procedure
Acute adverse events were defined as those serious events with an onset date ≤ 7 days post-procedure
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Time frame: 7 days through 2 years
Late adverse events were defined as those serious events with an onset date > 7 days post-procedure
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Time frame: Implant through 2 years
Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years
Number of Participants With Major Bleeding Events
Time frame: Implant through 2 years
Clinical events were adjudicated by the CEC as major bleeding events if they met the definition of Type 3 or greater on the Bleeding Academic Research Consortium (BARC) scale.
7 secondary outcomes
Number of Participants With Technical Success
Time frame: During implant procedure, approximately 30 to 60 minutes
Number of Participants With Procedural Success
Time frame: During the implant procedure and hospital stay, approximately 1 or 2 days
Number of Participants With Oral Anti-coagulation Usage
Time frame: At discharge, approximately 1 or 2 days after the procedure
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 1 to 3 months
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 6 months
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 12 months
Number of Participants With Oral Anti-coagulation Usage
Time frame: At 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34381870De Caterina AR, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Fischer S, Lund J, Montorfano M, Gage R, Lam SCC, Berti S. Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer Amulet Observational Study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100848. doi: 10.1016/j.ijcha.2021.100848. eCollection 2021 Aug.
- Derived from this study: PubMed 33762228Piayda K, Hellhammer K, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Gage R, Zeus T. Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study. BMJ Open. 2021 Mar 24;11(3):e040455. doi: 10.1136/bmjopen-2020-040455.
- Derived from this study: PubMed 33495144Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Lam SCC, Freixa X, Gage R, Diener HC, Schmidt B. Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study. EuroIntervention. 2021 Oct 20;17(9):774-782. doi: 10.4244/EIJ-D-20-01309.
- Derived from this study: PubMed 32972570Tarantini G, D'Amico G, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Lam SCC, Cruz-Gonzalez I, Gage R, Zhao H, Omran H, Odenstedt J, Nielsen-Kudsk JE. The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study. JACC Cardiovasc Interv. 2020 Sep 28;13(18):2099-2108. doi: 10.1016/j.jcin.2020.06.003.
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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.
David Hildick-Smith, MD principal investigator
Brighton and Sussex University Hospitals
Claudio Tondo, MD PhD principal investigator
University of Milan
51 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Thromboembolism, run by Abbott Medical Devices at 51 sites in 16 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 6 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: finished, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Germany, Italy, Spain, France, United Kingdom and 11 more countries. 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?
Yes. Results are posted in the registry (first posted 30 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Acute Serious Adverse Events (time frame: 0 to 7 days post procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02447081, which also lists 4 linked publications.
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 30 Dec 2019; AzTrials last refreshed its copy on 31 Oct 2026.