Valved Graft PMCF Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04754217
• Collaborator: (none)
• Enrollment: 260
• Locations: 21
• Anticipated Duration (Months): 97.6
• Patients Per Site: 12.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease; Ascending Aorta Abnormality; Aortic Dissection	Device: VAVGJ; Device: CAVGJ

Study Design

• Study Type: Observational
• Anticipated Enrollment: 260 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Valved Graft Post-Market Clinical Follow-up Study
• Actual Study Start Date: Jul 13, 2021
• Anticipated Primary Completion Date: Jul 1, 2029
• Anticipated Study Completion Date: Sep 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Group 1 VAVGJ	Device: VAVGJ; Replacement of the aortic valve and ascending aorta
Group 2 CAVGJ	Device: CAVGJ; Replacement of the aortic valve and ascending aorta

Outcome Measures

Primary Outcome Measures

1. annualized event rate of all-cause mortality [5 Years]

   Primary Safety Endpoint

2. annualized event rate of reintervention [5 Years]

   Primary Effectiveness Endpoint

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement

Exclusion Criteria:

• anticoagulation therapy intolerant

• active endocarditis

• anatomical or medical, surgical, psychological or social contraindications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48104
2	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
3	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
4	Klinik Floridsdorf	Vienna		Austria	1012
5	Rigshospitalet	Copenhagen		Denmark	2100
6	CHU de Besancon - Jean Minjoz	Besançon		France	25030
7	CHRU Lille	Lille		France	59037
8	Groupe Hospitalier Bichat - Claude Bernard	Paris		France	75877
9	Herz-und Diabetes Zentrum NRW	Bad Oeynhausen		Germany	32545
10	Deutsches Herzzentrum Berlin	Berlin		Germany	13353
11	Klinikum Links der Weser	Bremen		Germany	28277
12	Medizinische Hochschule Hannover	Hannover		Germany	30625
13	Policlinico S.Orsola-Malpighi	Bologna		Italy	40138
14	Ospedale San Raffaele	Milan		Italy	20132
15	Policlinico San Donato	San Donato Milanese		Italy	20097
16	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Krakow		Poland	31-202
17	The Cardinal Stefan Wyszynski Institute of Cardiology	Warsaw		Poland	04-628
18	Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi	Łódź		Poland	92-213
19	Hospital Universitario del Vinalopó	Elche		Spain	03293
20	Hospital Universitario Son Espases	Palma De Mallorca		Spain	07120
21	James Cook University Hospital	Middlesbrough		United Kingdom	TS43BW

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT04754217
• Other Study ID Numbers: ABT-CIP-10386
• First Posted: Feb 15, 2021
• Last Update Posted: Jun 8, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Abbott Medical Devices: Aortic Root Replacement; Ascending Aorta Replacement; Valved Graft; CAVGJ; VAVGJ
• Additional relevant MeSH terms: Aneurysm, Dissecting; Aortic Valve Disease

Study Results

No Results Posted as of Jun 8, 2022