THE ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study

• Sponsor: JenaValve Technology, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02732691
• Collaborator: (none)
• Enrollment: 90
• Locations: 14
• Arm: 1
• Anticipated Duration (Months): 112
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction	Device: JenaValve Pericardial TAVR System	N/A

Detailed Description

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: THE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR) Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.	Device: JenaValve Pericardial TAVR System; Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Outcome Measures

Primary Outcome Measures

1. All-Cause Mortality at 30 Days [30 days]

   All-cause mortality rate at 30 days

Secondary Outcome Measures

1. Mortality [up to 5 years]

   All cause mortality and cardiovascular mortality

2. Myocardial Infarction [up to 5 years]

   Peri-procedural and spontaneous myocardial infarction

3. Neurological Complications [up to 5 years]

   TIA and stroke

4. Bleeding & Vascular Complications [up to 5 years]

   Major and minor bleeding

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient with severe degenerative native aortic stenosis (AS).

• Patient at high risk for open surgical valve replacement

• Patient symptomatic according to NYHA functional class II or higher

Exclusion Criteria:

• Congenital uni- or bicuspid aortic valve morphology

• Previous prosthetic aortic valve (bioprosthesis or mechanical) implant

• Endocarditis or other active infection

• Need for urgent or emergent TAVR procedure for any reason

• Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
2	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Emory University Hospital	Atlanta	Georgia	United States	30322
4	University of Michigan	Ann Arbor	Michigan	United States	48109
5	Columbia University Medical Center	New York	New York	United States	10032
6	University of Washington	Seattle	Washington	United States	98195
7	Deutsches Herzzentrum Berlin	Berlin		Germany	13353
8	Universitätsklinikum Halle	Halle (Saale)		Germany	6120
9	Universitäres Herzzentrum Hamburg	Hamburg		Germany	20246
10	Herzzentrum der Universität zu Köln	Köln		Germany	50937
11	Leiden University Medical Center	Leiden		Netherlands	2333
12	St. Antonius Hospital	Nieuwegein		Netherlands	3435
13	Erasmus University Medical Center	Rotterdam		Netherlands	3062
14	Waikato Hospital	Hamilton		New Zealand	3240

Sponsors and Collaborators

• JenaValve Technology, Inc.

Investigators

• Study Chair: Martin B Leon, MD, New York-Presbyterian Hospital/Columbia University Medical Center, USA
• Principal Investigator: Torsten Vahl, MD, New York-Presbyterian Hospital/Columbia University Medical Center, USA
• Principal Investigator: Vinod Thourani, MD, Emory University School of Medicine, USA
• Principal Investigator: Hendrik Treede, MD, University Hospital Bonn, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JenaValve Technology, Inc.
• ClinicalTrials.gov Identifier: NCT02732691
• Other Study ID Numbers: CP-0003; P02C220_JV06EFS_CIP; CA-0001 EU; CA-0001 Germany; CA-0010
• First Posted: Apr 11, 2016
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by JenaValve Technology, Inc.: Valvular Heart Disease; Critical/Severe Aortic Stenosis; High risk symptomatic patients
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Diseases; Aortic Valve Stenosis; Heart Valve Diseases; Ventricular Outflow Obstruction; Constriction, Pathologic

Study Results

No Results Posted as of Mar 23, 2022