The ASCEND study Version B
Research type
Research Study
Full title
Assessment of the safety and performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a multi- center post-market study (ASCEND)
IRAS ID
294358
Contact name
Reuben Jeganathan
Contact email
Sponsor organisation
HARPOON Medical, an indirect wholly-owned subsidiary of Edwards Lifesciences Corporation
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 20 days
Research summary
Research Summary
Mitral valve disease is the second most common valvular heart disorder requiring surgery in Europe, with nearly 8 million Europeans estimated to have severe mitral valve regurgitation (MR) (AGENAS, 2015).
The HARPOON™ System - a beating Heart Mitral Valve Repair System - is indicated to reduce the degree of mitral regurgitation in patients with severe mitral regurgitation caused by mid-segment posterior leaflet prolapse as a result of degenerative mitral valve disease by delivering and anchoring ePTFE chords to the prolapsed mitral valve leaflet in a beating heart.
This study will evaluate the long-term safety and performance of the Harpoon™ System in patients with severe degenerative mitral regurgitation due to mid-segment posterior leaflet prolapse in the post-market phase. \n\n250 patients in up to 25 research centres in Europe will be treated in this single-arm, prospective, multicentre non-randomised and open-label post market study. Patients treated with the Harpoon™ System will be followed-up at 7 days or discharge from hospital (whichever occurs first), at 30 days, and at 6, 12, 18, 36, 48 and 60 months post-treatment.
Summary of Results
The objective of the ASCEND study was to assess the safety and performance of the HARPOON Mitral Valve Repair System in patients experiencing severe mitral regurgitation due to mid-segment posterior leaflet prolapse. This is the final report for the ASCEND study, which was terminated when the decision was made to no longer market the HARPOON device.
Between 2 October 2020 (first enrollment) to 25 December 2022 (last patient study exit date), 42 subjects were enrolled (enrolled cohort) at ten sites. Of these enrolled subjects, 41 passed study screening and entered the HARPOON MVRS procedure (attempted cohort), of which 40 have been implanted with at least one ePTFE chord.
In the attempted cohort, 24 subjects reached their 12-month follow-up visit. Compliance with protocol-required follow-ups was ≥ 87.5%. Five major protocol deviations and 64 minor protocol deviations were reported.
The primary safety endpoint was 97.6% freedom from all-cause mortality, disabling stroke, and life-threatening bleeding at 30 days post-implant. The primary performance endpoint was 68.4% (26/38) procedure success at 30 days post-implant.
Technical success of the HARPOON Mitral Valve Repair System (MVRS), defined as implantation of at least three chords, leaving the operating room, and no conversion to open heart surgery, was achieved in 92.7% (38/41) of the attempted cohort.
Freedom from events at 1 year post-implant were 70.5% from major device- or procedure-related SAE, 100% from ePTFE chord rupture as reported by the Echo Core Lab analysis of submitted TTE images, 96.7% from reintervention due to ePTFE chord rupture as adjudicated by the CEC, 84.0% from reintervention on the mitral valve, and 52.5% from greater than or equal to moderate MR.
In the ASCEND study, 12 major device or procedure-related SAE occurred in nine subjects. No USADE were reported.
Change from baseline NYHA classification was positive in 58.8% (10/17), same in 35.3% (6/17) and worsened in 5.9% (1/17) of subjects at 12 months.
One death occurred in the ASCEND study. The CEC adjudicated that the death was possibly procedure-related, but unlikely to be device-related, with cause of death likely due to sudden respiratory failure leading to cardiac arrest. Four subjects required reinterventions on their mitral valve, two of which received additional HARPOON ePTFE chords during the reintervention.
Surgical repair of mitral valves is associated with excellent outcomes.3F4,4F5,5F6 As a result, the American College of Cardiology and American Heart Association guidelines indicate that mitral valve repair is preferable to mitral valve replacement, when possible.6F7 The HARPOON mitral valve repair system is a novel minimally invasive approach for repair of the mitral chordae. This beating heart method allows for repair of the mitral valve without the need to place the patient on cardiopulmonary bypass. Minimally invasive approaches such as this have potential to provide new treatment options for patients with degenerative MR.
The risk of the HARPOON MVRS to existing patients is monitored through Vigilance Reporting requirements. No risk to future patients is anticipated because HARPOON MVRS is no longer on the market. No future studies are planned.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0077
Date of REC Opinion
28 Jun 2021
REC opinion
Favourable Opinion