Amplatzer™Amulet™ Post-Market Study (Amulet™PMS)

Stroke Clinical Trial

— Amulet™PMS  

Official title:

Amplatzer™Amulet™ Observational Post-Market Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447081
• Other study ID #: SJM-CIP-10053
• Status: Completed
• Start date: June 1, 2015
• Est. completion date: October 23, 2018

Study information

• Verified date: December 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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."

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1088
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke
• Thromboembolism

Intervention

Device:
• Subjects implanted with Amulet Device
Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.

Locations

Country	Name	City	State
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Belgium	Universitaire Ziekenhuizen Gasthuisberg	Leuven
Chile	Hospital Clinico San Borja Arriaran	Santiago
Denmark	Rigshospitalet	Copenhagen
Finland	Helsinki University Central Hospital	Helsinki	Uusimaa
Finland	Turku University Hospital	Turku
France	CHU d'Amiens	Amiens	Picardy
France	CHU du Bocage	Dijon	Burgundy
France	CHRU Lille	Lille	North-Calais
France	Hopital Haut Leveque	Pessac	Aquitaine
Germany	Zentralklinik Bad Berka	Bad Berka
Germany	Zentralklinik Bad Berka Gmbh	Bad Berka	Thuringia
Germany	Segeberger Kliniken Gmbh	Bad Segeberg
Germany	Segeberger Kliniken GmbH	Bad Segeberg
Germany	Charité - Universitätsmedizin Berlin (CBF)	Berlin
Germany	St. Marien Hospital Bonn	Bonn
Germany	Klinikum Coburg	Coburg	Bavaria
Germany	Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt	Darmstadt	Hesse
Germany	Herzzentrum Dresden	Dresden
Germany	Universitätsklinikum Düsseldorf	Duesseldorf	North Rhine-Westphal
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt
Germany	CardioVaskuläres Centrum St. Katharinen	Frankfurt	Hesse
Germany	Klinikum Frankfurt Höchst	Frankfurt
Germany	Internistische Klinik Dr. Müller, München-Thalkirchen	Muenchen	Bavaria
Germany	Harzklinikum Dorothea Christiane Erxleben GmbH	Quedlinburg
Germany	Universitaetsklinikum Ulm	Ulm	Bavaria
Germany	Rems-Murr-Klinikum Winnenden	Winnenden
Ireland	Mater Hospital	Dublin
Israel	The Chaim Sheba Medical Center	Tel Hashomer
Italy	Nuovo Ospedale Civile Sant'Agostino Estense	Baggiovara, 1355	Modena
Italy	Azienda Ospedaliera S. Anna e S. Sebastiano	Caserta
Italy	Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio	Massa
Italy	Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia	Mestre	Veneto
Italy	Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan	Milan
Italy	San Raffaele Hospital	Milan
Italy	Ospedale Luigi Sacco	Milano
Italy	Università degli Studi di Padova	Padova	Veneto
Netherlands	Amsterdam Academic Medical Centre	Veenendaal
Norway	Ulleval Universitetssykehus	Oslo
Poland	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw
Poland	Slaskie Centrum Chorob Serca	Warszawa
Spain	Hospital Universitario Infanta Cristina	Badajoz	Extremadura
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona	Catalonia
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Balearic Island
Spain	Hospital Universitario de Salamanca	Salamanca	Castile And Leon
Spain	Hospital Universitario Virgen Macarena	Sevilla	Andalusia
Sweden	Karolinska University Hospital Huddinge	Stockholm
United Kingdom	The Royal Sussex Country Hospital	Brighton	South East England
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool	Northwest England
United Kingdom	St Thomas Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Belgium,  Chile,  Denmark,  Finland,  France,  Germany,  Ireland,  Israel,  Italy,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 to 7 days post procedure
Primary	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	7 days through 2 years
Primary	Number of Participants With Ischemic Stroke, Systemic Embolism and Cardiovascular Death	Occurrence of ischemic stroke, systemic embolism, and cardiovascular death through 2 years	Implant through 2 years
Primary	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.	Implant through 2 years
Secondary	Number of Participants With Technical Success	Technical success is defined as successful implantation of the Amulet device in the left arterial appendage (LAA).	During implant procedure, approximately 30 to 60 minutes
Secondary	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	During the implant procedure and hospital stay, approximately 1 or 2 days
Secondary	Number of Participants With Oral Anti-coagulation Usage		At discharge, approximately 1 or 2 days after the procedure
Secondary	Number of Participants With Oral Anti-coagulation Usage		At 1 to 3 months
Secondary	Number of Participants With Oral Anti-coagulation Usage		At 6 months
Secondary	Number of Participants With Oral Anti-coagulation Usage		At 12 months
Secondary	Number of Participants With Oral Anti-coagulation Usage		At 24 months