Impact of Postdilatation With the InterValve V8 Aortic Valvuloplasty Balloon Following TAVI Procedure

NCT02472106 | Completed DMC

• 1 other identifier: 1302-001
• Study Type: observational
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to monitor the safety and performance of the V8 balloon when used as a postdilatation balloon in self-expanding Transcatheter Aortic Valve Implantation (TAVI) device procedures. The study product is CE marked for balloon aortic valvuloplasty (BAV), and is being investigated for an expanded intended use.

Conditions

Aortic Valve Stenosis

Keywords

Aortic Valve; TAVI; Stenosis

Outcome Measures

Primary Outcomes (2)

• Efficacy Endpoint: V8 Device Performance

  Rate of successful V8 balloon fixation within the TAVI prosthesis: during rapid ventricular pacing, proximal and distal balloon segments are securely fixed on either side of the native aortic valve annulus following inflation

  Intra-Procedure

• Safety Endpoint: Serious Adverse Events (SAE)

  The composite of SAEs as defined by the Valve Academic Research Consortium (VARC II)

  Intra-procedure until discharge or 7 days post-procedure, whichever comes first. (Typical discharge is expected to be within 7 days.)

Secondary Outcomes (5)

• Efficacy Endpoint: Degree of Paravalvular Leak (PVL)

  Intra-Procedure

• Efficacy Endpoint: Procedural Parameter - V8 Dimension

  Intra-Procedure

• Efficacy Endpoint: Procedural Parameter - CoreValve Dimension

  Intra-Procedure

• Efficacy Endpoint: Procedural Parameter - Aortic Valve Measurement

  Intra-Procedure

• Safety Endpoint: 24hr Complication

  24 hours post-procedure

Interventions

Post-dilatation DEVICE

Post-dilatation in self-expanding TAVI device procedures

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic - Patients at each enrolling clinic who are to be treated with the Medtronic CoreValve or other self-expanding TAVI device are eligible for enrollment.

You may qualify if:

• Subjects with severe symptomatic aortic stenosis (AS) indicated and scheduled for a transcatheter aortic valve implant (TAVI) with the Medtronic CoreValve or another self-expanding TAVI device.
• The TAVI device size is determined preoperatively with CTA according to standard guidelines. Patients may undergo transfemoral, subclavian, or transaortic approach.
• Balloon postdilatation (BPD) is carried out after CoreValve or other self-expanding TAVI device implantation if, based on operator's judgment, BPD is indicated because of presence of paravalvular leak (PVL).
• Hemodynamically stable for 3 - 10 minutes after the TAVI procedure.
• Probable survival to hospital discharge.
• Subject is competent, willing to comply with evaluations, understands risks, benefits and alternatives and has signed the Informed Consent Form.

You may not qualify if:

• Cardiogenic shock, as defined by a consistent systolic blood pressure \<80 mmHg off vasopressors or \<90 mmHg on vasopressors.
• PVL occurring secondary to excessively high or low valve positioning.
• Trauma or significant structural damage to underlying native tissue calls for emergent intervention or threatens long-term outcome prior to the BPD.
• Patients receiving two valves (i.e. aortic THV valve in valve).
• Patients with AS secondary to congenital valve disease including bicuspid aortic valve.
• PVL occurring due to TAVI device under sizing. Example of determining the undersizing is to calculate the Cover Index which represents the percent of over sizing of the nominal transcatheter heart valve (THV) area compared to the measured native valve annulus area. Under sizing is defined as TAVI screening CTA with a pre procedure cover index by area of \<5%.
• Vulnerable subjects and any subjects incapable of giving consent, including patients with incurable diseases, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and subjects with cognitive impairment, such as persons with a mental illness or dementia.

Sponsors & Collaborators

• InterValve, Inc.: lead

MeSH Terms

Conditions

Aortic Valve Stenosis; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 15, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08