NCT01627691

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

Completed NA Results posted Last updated 12 May 2020

What this trial tests

NA trial testing Lotus Valve System in Transcatheter Aortic Valve Replacement in 250 participants. Completed in 13 May 2019.

Timeline

8 October 2012

Primary endpoint
30 May 2014

13 May 2019

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	250
Start date	8 October 2012
Primary completion	30 May 2014
Estimated completion	13 May 2019
Sites	20 locations across France, Italy, Netherlands, Sweden, United Kingdom, Germany, Switzerland, Australia

Drugs / interventions tested

• Lotus Valve System

Conditions studied

• Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

70 and older, any sex, with Transcatheter Aortic Valve Replacement. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Device Performance Endpoint: Mean Aortic Valve Pressure Gradient at 30 Days Post Implant Procedure Primary · 30 days

Mean aortic valve pressure gradient at 30 days post implant procedure as measured by echocardiography and assessed by an independent core laboratory.

Group	Value	95% CI
REPRISE II and Extension Overall	11.45	± 5.20

Primary Safety Endpoint: All-cause Mortality at 30 Days Post Implant Procedure Primary · 30 days

Mortality at 30 days from all patients enrolled in the study (ITT population): the proportion of patients who experience an event through 30 days post-procedure out of the patients who have either had an event within 30 days post-procedure or who were event-free with last follow-up at least 23 days post-procedure

Group	Value	95% CI
REPRISE II and Extension Overall	11

Effective Orifice Area Secondary · 30 days

Effective orifice area measured by echocardiography at 30 days and assessed by an independent core laboratory (ITT population)

Group	Value	95% CI
REPRISE II and Extension Overall	1.73	1.66 – 1.79

Device Performance Endpoint: Successful Vascular Access Secondary · Post-procedure

Successful vascular access, delivery and deployment of the Lotus Valve System and successful retrieval of the delivery system as reported from site

Group	Value	95% CI
REPRISE II and Extension Overall	247

Device Performance Endpoint: Successful Retrieval Secondary · Post-procedure

Successful retrieval (complete resheathing of the Lotus valve in the catheter and removal from the body) of the Lotus Valve System if retrieval is attempted, as reported from site

Group	Value	95% CI
REPRISE II and Extension Overall	12

Device Performance Endpoint: Successful Repositioning Secondary · Post-procedure

Successful repositioning (partial or complete resheathing of the Lotus Valve in the catheter and redeployment in a more accurate position within the aortic valve annulus) of the Lotus Valve System if repositioning is attempted for the last valve attempted, as reported from site

Group	Value	95% CI
REPRISE II and Extension Overall	85

Device Success According to the Valve Academic Research Consortium (VARC) Secondary · Post-procedure

Absence of procedural mortality as reported from site AND Correct positioning of a single prosthetic heart valve into the proper anatomical location as reported from site AND Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation as measured from an independent core lab on the post-procedure echocardiography)

Group	Value	95% CI
REPRISE II and Extension Overall	96

Grade of Aortic Valve Regurgitation Secondary · 30 days

Grade of paravalvular aortic valve regurgitation at 30 days as measured by echocardiography and assessed by an independent core laboratory

Group	Value	95% CI
REPRISE II and Extension Overall	159
REPRISE II and Extension Overall	18
REPRISE II and Extension Overall	31
REPRISE II and Extension Overall	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Primary Endpoint (30days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

REPRISE II and Extension Overall

Serious: 152/250 (61%)

Deaths: 11/250

Serious adverse events (138 terms)

Reaction	System	REPRISE II and Extension O…
Total	Cardiac disorders	—
Atrioventricular block complete	Cardiac disorders	—
Total	Vascular disorders	—
Total	General disorders	—
Total	Infections and infestations	—
Total	Nervous system disorders	—
Catheter site haematoma	General disorders	—
Total	Respiratory, thoracic and mediastinal disorders	—
Total	Blood and lymphatic system disorders	—
Total	Injury, poisoning and procedural complications	—
Anaemia	Blood and lymphatic system disorders	—
Total	Gastrointestinal disorders	—
Total	Investigations	—
Atrial fibrillation	Cardiac disorders	—
Bundle branch block left	Cardiac disorders	—
Catheter site haemorrhage	General disorders	—
Atrioventricular block	Cardiac disorders	—
Cardiac tamponade	Cardiac disorders	—
Haemorrhage	Vascular disorders	—
Hypotension	Vascular disorders	—
Cerebrovascular accident	Nervous system disorders	—
Haemoglobin decreased	Investigations	—
Cardiac arrest	Cardiac disorders	—
Femoral artery dissection	Vascular disorders	—
Total	Psychiatric disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	REPRISE II and Extension O…
Total	Cardiac disorders	—
Bundle branch block left	Cardiac disorders	—
Total	General disorders	—
Catheter site haematoma	General disorders	—
Total	Vascular disorders	—
Catheter site haemorrhage	General disorders	—
Pyrexia	General disorders	—
Total	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Hypertension	Vascular disorders	—
Atrioventricular block first degree	Cardiac disorders	—
Hypotension	Vascular disorders	—
Total	Blood and lymphatic system disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Atrial fibrillation	Cardiac disorders	—

Most-reported serious reactions: Total, Atrioventricular block complete, Total, Total, Total, Total, Catheter site haematoma, Total.

Data from ClinicalTrials.gov NCT01627691 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study.
   Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, et al · · 2014 · cited 155× · PMID 25257635 · DOI 10.1016/j.jacc.2014.05.067
2. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study.
   Meredith IT, Walters DL, Dumonteil N, Worthley SG, et al · · 2016 · cited 87× · PMID 26892084 · DOI 10.1016/j.jcin.2015.10.024