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

• ClinicalTrials.gov Identifier: NCT02732691
• Recruitment Status: Active, not recruiting
• First Posted: April 11, 2016
• Last Update Posted: March 23, 2022
• Sponsor: JenaValve Technology, Inc.
• Information provided by (Responsible Party): JenaValve Technology, Inc.

Tracking Information

• First Submitted Date: March 18, 2016
• First Posted Date: April 11, 2016
• Last Update Posted Date: March 23, 2022
• Actual Study Start Date: February 2016
• Actual Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 28, 2019)

All-Cause Mortality at 30 Days [ Time Frame: 30 days ]

All-cause mortality rate at 30 days

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: October 28, 2019)

• Mortality [ Time Frame: up to 5 years ]
  All cause mortality and cardiovascular mortality
• Myocardial Infarction [ Time Frame: up to 5 years ]
  Peri-procedural and spontaneous myocardial infarction
• Neurological Complications [ Time Frame: up to 5 years ]
  TIA and stroke
• Bleeding & Vascular Complications [ Time Frame: up to 5 years ]
  Major and minor bleeding

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: THE ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study
• 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)
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Aortic Valve Stenosis
• Heart Valve Diseases
• Heart Diseases
• Cardiovascular Diseases
• Ventricular Outflow Obstruction

Intervention

Device: JenaValve Pericardial TAVR System

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Study Arms

Experimental: Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.

Intervention: Device: JenaValve Pericardial TAVR System

• Publications *: Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: November 4, 2018): 90
• Original Enrollment: Not Provided
• Estimated Study Completion Date: June 2025
• Actual Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Netherlands, New Zealand, United States

Administrative Information

• NCT Number: NCT02732691
• Other Study ID Numbers: CP-0003; P02C220_JV06EFS_CIP ( Other Identifier: JenaValve Technology Inc. ); CA-0001 EU ( Other Identifier: JenaValve Technology Inc. ); CA-0001 Germany ( Other Identifier: JenaValve Technology Inc. ); CA-0010 ( Other Identifier: JenaValve Technology Inc. )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: JenaValve Technology, Inc.
• Original Responsible Party: [Redacted]
• Current Study Sponsor: JenaValve Technology, Inc.
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

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

• PRS Account: JenaValve Technology, Inc.
• Verification Date: March 2022