The objective is to assess the effectiveness of the Mammoth Balloon Dilatation Catheter in patients with a significant narrowing of the main heart valve. This will be evaluated in patients undergoing either a balloon dilation to widen the valve or a minimally invasive valve replacement procedure.

A prospective, single-arm, multi-centre, real-world evaluation of the Mammoth Balloon Dilatation Catheter’s performance in patients with severe native aortic stenosis undergoing balloon aortic valvuloplasty alone or dilatation prior to Transcatheter Aortic Valve Implantation. - Mammoth BDC-1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064701

Enrollment

210

Registered

2024-03-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis

Interventions

Intervention1: Mammoth™ Balloon Dilatation Catheter (BDC): The Mammoth BDC has been extensively used for pre-dilatation of native stenotic aortic valve prior to the implantation of a novel balloon exp

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who will be treated with Mammoth BDC as per Investigator’s discretion in severe native aortic stenosis for BAV alone or dilatation prior to the implantation of transcatheter aortic valve. 2. Male and female patients of more than 18 year of age. 3. Patient or his or her legally authorized representative (if applicable) agrees to provide written informed consent as approved by respective Ethics Committee and applicable regulatory authorities.

Exclusion criteria

Exclusion criteria: 1.Patients in whom antiplatelet and or anticoagulant therapy are contraindicated. 2. The patient has had previous aortic valve replacement. 3. Pregnant or lactating women. 4. Any illness or condition which, in the Investigators discretion will compromise patient safety, or interfere with the interpretation of the treatment results.

Design outcomes

Primary

Measure	Time frame
Device successTimepoint: Pre-Procedure	—

Secondary

Measure	Time frame
Serious Adverse Event Peri-Procedure Hemodynamic Changes Post-Procedure Hemodynamic Changes Acute balloon performance Acute technical success of Python Introducer Sheath Feedback Score for Navigator Transcatheter Heart Valve Delivery System Device Success of Navigator Transcatheter Heart Valve Delivery SystemTimepoint: Peri-procedure, Discharge, Immediately after procedure, At Index-procedure	—

Countries

India

Contacts

Public ContactDr John Jose

Christian Medical Centre Vellore

drjohnjose@gmail.com9843593721

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026