Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation

• Full understanding and willing to provide informed consent to study enrolment

• Age ≥ 18 years

Locations
Other Locations
United Kingdom
Royal Victoria Hospital
NOT_YET_RECRUITING
Belfast
Royal Papworth
NOT_YET_RECRUITING
Cambridge
Castle Hill Hull
RECRUITING
Cottingham
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Dr. Javaid Iqbal, MRCP, PhD
J.Iqbal@sheffield.ac.uk
7788438471
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 250
Treatments
Severe aortic valve stenosis
Hydra transcatheter aortic valve (THV) series
Sponsors
Leads: Sahajanand Medical Technologies Limited
Collaborators: Psephos Biomedica

This content was sourced from clinicaltrials.gov