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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02447081




Registration number
NCT02447081
Ethics application status
Date submitted
27/04/2015
Date registered
18/05/2015
Date last updated
30/12/2019

Titles & IDs
Public title
Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)
Scientific title
Amplatzer™Amulet™ Observational Post-Market Study
Secondary ID [1] 0 0
SJM-CIP-10053
Universal Trial Number (UTN)
Trial acronym
Amulet™PMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Thromboembolism 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Subjects implanted with Amulet Device

Subjects implanted with Amulet Device - All subjects who receive the Amulet device will be followed.


Treatment: Devices: Subjects implanted with Amulet Device
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Acute Serious Adverse Events
Timepoint [1] 0 0
0 to 7 days post procedure
Primary outcome [2] 0 0
Number of Participants With Late Serious Adverse Events Greater Than 7 Days Post Procedure
Timepoint [2] 0 0
7 days through 2 years
Primary outcome [3] 0 0
Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death
Timepoint [3] 0 0
Implant through 2 years
Primary outcome [4] 0 0
Number of Participants With Major Bleeding Events
Timepoint [4] 0 0
Implant through 2 years
Secondary outcome [1] 0 0
Number of Participants With Technical Success
Timepoint [1] 0 0
During implant procedure, approximately 30 to 60 minutes
Secondary outcome [2] 0 0
Number of Participants With Procedural Success
Timepoint [2] 0 0
During the implant procedure and hospital stay, approximately 1 or 2 days
Secondary outcome [3] 0 0
Number of Participants With Oral Anti-coagulation Usage
Timepoint [3] 0 0
At discharge, approximately 1 or 2 days after the procedure
Secondary outcome [4] 0 0
Number of Participants With Oral Anti-coagulation Usage
Timepoint [4] 0 0
At 1 to 3 months
Secondary outcome [5] 0 0
Number of Participants With Oral Anti-coagulation Usage
Timepoint [5] 0 0
At 6 months
Secondary outcome [6] 0 0
Number of Participants With Oral Anti-coagulation Usage
Timepoint [6] 0 0
At 12 months
Secondary outcome [7] 0 0
Number of Participants With Oral Anti-coagulation Usage
Timepoint [7] 0 0
At 24 months

Eligibility
Key inclusion criteria
1. Subject with history of paroxysmal, persistent or permanent NVAF
2. Subject who is 18 years or older, or of legal age to give informed consent specific to state and national law
3. Subject who is eligible for an Amulet LAA Occluder device according to current international guidelines and per physician discretion
4. Subject who is willing and capable of providing informed consent, participating in all associated study activities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject with evidence of an intracardiac thrombus
2. Subject with active infection or active endocarditis or other infections producing bacteremia
3. Subject where the placement of the device would interfere with any intracardiac or intravascular structures
4. Subject with any medical disorder that would interfere with completion or evaluation of clinical study results
5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
6. Subject with LAA anatomy that does not accommodate a device per the sizing guidelines

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/10/2018
Sample size
Target
Accrual to date
Final
1088
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
WA 6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
Chile
State/province [2] 0 0
Santiago
Country [3] 0 0
Denmark
State/province [3] 0 0
Copenhagen
Country [4] 0 0
Finland
State/province [4] 0 0
Uusimaa
Country [5] 0 0
Finland
State/province [5] 0 0
Turku
Country [6] 0 0
France
State/province [6] 0 0
Aquitaine
Country [7] 0 0
France
State/province [7] 0 0
Burgundy
Country [8] 0 0
France
State/province [8] 0 0
North-Calais
Country [9] 0 0
France
State/province [9] 0 0
Picardy
Country [10] 0 0
Germany
State/province [10] 0 0
Bavaria
Country [11] 0 0
Germany
State/province [11] 0 0
Hesse
Country [12] 0 0
Germany
State/province [12] 0 0
North Rhine-Westphal
Country [13] 0 0
Germany
State/province [13] 0 0
Thuringia
Country [14] 0 0
Germany
State/province [14] 0 0
Bad Berka
Country [15] 0 0
Germany
State/province [15] 0 0
Bad Segeberg
Country [16] 0 0
Germany
State/province [16] 0 0
Berlin
Country [17] 0 0
Germany
State/province [17] 0 0
Bonn
Country [18] 0 0
Germany
State/province [18] 0 0
Dresden
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Quedlinburg
Country [21] 0 0
Germany
State/province [21] 0 0
Winnenden
Country [22] 0 0
Ireland
State/province [22] 0 0
Dublin
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Hashomer
Country [24] 0 0
Italy
State/province [24] 0 0
Modena
Country [25] 0 0
Italy
State/province [25] 0 0
Veneto
Country [26] 0 0
Italy
State/province [26] 0 0
Caserta
Country [27] 0 0
Italy
State/province [27] 0 0
Massa
Country [28] 0 0
Italy
State/province [28] 0 0
Milano
Country [29] 0 0
Italy
State/province [29] 0 0
Milan
Country [30] 0 0
Netherlands
State/province [30] 0 0
Veenendaal
Country [31] 0 0
Norway
State/province [31] 0 0
Oslo
Country [32] 0 0
Poland
State/province [32] 0 0
Warsaw
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Spain
State/province [34] 0 0
Andalusia
Country [35] 0 0
Spain
State/province [35] 0 0
Balearic Island
Country [36] 0 0
Spain
State/province [36] 0 0
Castile And Leon
Country [37] 0 0
Spain
State/province [37] 0 0
Catalonia
Country [38] 0 0
Spain
State/province [38] 0 0
Extremadura
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Sweden
State/province [40] 0 0
Stockholm
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Northwest England
Country [42] 0 0
United Kingdom
State/province [42] 0 0
South East England
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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."
Trial website
https://clinicaltrials.gov/study/NCT02447081
Trial related presentations / 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.
Piayda 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.
Aminian 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.
Tarantini 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.
Public notes

Contacts
Principal investigator
Name 0 0
David Hildick-Smith, MD
Address 0 0
Brighton and Sussex University Hospitals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02447081