Hotline 24/7: 0909384389

Share links:

CONFORM pivotal trial of CLAAS system begins enrolment

Ngày 29/06/2022 08:09 | Lượt xem: 544

Conformal Medical has announced the launch of the CONFORM pivotal trial with the enrolment of the first patients at two US sites.

The investigational device exemption (IDE) study will evaluate the safety and efficacy of the company’s CLAAS system compared to commercially available LAAO devices to support US Food and Drug Administration (FDA) premarket approval.

The first patients were treated at their respective institutions by co-principal investigators of the trial, Shephal Doshi (Pacific Heart Institute, Santa Monica, USA) and William Gray (Lankenau Institute for Medical Research, Philadelphia, USA).

“I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with atrial fibrillation (AF),” stated Gray. “In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal and incidence of device-related thrombus.”

The prospective, multicentre, randomised controlled study will enrol approximately 1,600 patients in the USA, Canada, and Japan. To date, over 75 patients have been successfully implanted with the CLAAS System as part of the company’s early feasibility studies.

“Based on our experience in the Early Feasibility Study, the CLAAS System is highly conformable to accommodate different anatomies,” stated Doshi. “The study is designed to demonstrate the benefits of this technology for both implanting physicians and patients.”

The CLAAS system is designed to seal the LAA in patients with non-valvular AF to reduce the risk of stroke without the need for anticoagulants.

Source CardiovascularNews

Duc Tin Clinic

Tin tức liên quan

Enrolment reaches midway point in trial of Early Bird bleed monitoring system

Eight-fold increased risk of heart attack seen in patients with subclinical obstructive coronary atherosclerosis

ACC 2023: REVIVED-BCIS-2 results challenge “long-held beliefs” on myocardial viability testing prior to PCI

Blood pressure successfully cut in RADIANCE II ultrasound renal denervation trial

New data examine mortality rates and cardiac damage in early-stage aortic stenosis patients

SUPPORT CONSULTANT

CUSTOMER REVIEWS

• I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

  I sincerely thank you !. Tel: 0938303275

• Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

  Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

• As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

• The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

• I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search

News

Customer support