Trial Outcomes & Findings for REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm (NCT NCT01383720)

Last Updated: 2017-06-20

Results Overview

Clinical procedural success defined as successful implantation of a Lotus Valve System (Device Success) without in-hospital Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) through discharge or 7 days post-procedure, whichever comes first.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Discharge or 7 days post-procedure, whichever comes first

Results posted on

2017-06-20

Participant Flow

Patients were identified by their physicians as meeting the study inclusion/exclusion criteria.

Screening materials from patients identified by the investigators as having met the inclusion and exclusion criteria were reviewed by a Case Review Committee to assess and confirm eligibility.

Participant milestones

Participant milestones
Measure	Lotus Valve System Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Overall Study STARTED	11
Overall Study Primary Endpoint (Discharge/7 Days)	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	83.0 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment Australia	11 participants n=5 Participants
General Medical History Diabetes mellitus (current)	5 participants n=5 Participants
General Medical History Hyperlipidemia (medically treated)	8 participants n=5 Participants
General Medical History Hypertension (medically treated)	10 participants n=5 Participants
General Medical History History of peripheral vascular disease	1 participants n=5 Participants
General Medical History Dialysis dependent renal failure	0 participants n=5 Participants
General Medical History Chronic obstructive pulmonary disease	1 participants n=5 Participants
Cardiac History Coronary artery disease	5 participants n=5 Participants
Cardiac History Previous percutaneous coronary intervention	2 participants n=5 Participants
Cardiac History Previous coronary artery bypass graft surgery	0 participants n=5 Participants
Cardiac History History of atrial fibrillation	5 participants n=5 Participants
New York Heart Association Class Class I	0 participants n=5 Participants
New York Heart Association Class Class II	6 participants n=5 Participants
New York Heart Association Class Class III	5 participants n=5 Participants
New York Heart Association Class Class IV	0 participants n=5 Participants
Modified Rankin Scale 0	10 participants n=5 Participants
Modified Rankin Scale 1	0 participants n=5 Participants
Modified Rankin Scale 2	1 participants n=5 Participants
Modified Rankin Scale 3 or higher	0 participants n=5 Participants
Neurological History Transient Ischemic Attack	1 participants n=5 Participants
Neurological History Cerebrovascular Accident	2 participants n=5 Participants
Aortic valve area (effective orifice area)	0.68 cm^2 STANDARD_DEVIATION 0.19 • n=5 Participants
Mean Aortic Valve Gradient	53.9 mmHg STANDARD_DEVIATION 20.9 • n=5 Participants
Left Ventricular Ejection Fraction	62.3 percent of LVEF STANDARD_DEVIATION 7.6 • n=5 Participants
Aortic regurgitation (moderate or severe)	4 participants n=5 Participants
Mitral Regurgitation (moderate or severe)	3 participants n=5 Participants
Body mass index	27.6 kg/m2 STANDARD_DEVIATION 6.0 • n=5 Participants
Serum Albumin	3.9 g/dL STANDARD_DEVIATION 0.4 • n=5 Participants
5-Meter Gait Speed	8.2 seconds STANDARD_DEVIATION 4.9 • n=5 Participants
Maximum Grip Strength Average	15.3 kg STANDARD_DEVIATION 5.7 • n=5 Participants
Katz Index	5.9 units on a scale STANDARD_DEVIATION 0.3 • n=5 Participants
Mini-Cognitive Assessment for Dementia	3.3 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Charlson Comorbidity Index Score	1.8 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants
Society of Thoracic Surgeons (STS) Score	4.9 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants
EuroScore	9.5 units on a scale STANDARD_DEVIATION 4.4 • n=5 Participants

PRIMARY outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Population: Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Clinical Procedural Success	9 participants

SECONDARY outcome

Timeframe: procedure

Population: Patients in whom repositioning of the Lotus Valve was attempted

Successful repositioning of the Lotus Valve System if repositioning is attempted

Outcome measures

Outcome measures
Measure	Lotus Valve System n=4 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Device Performance Endpoint-Repositioning	4 participants

SECONDARY outcome

Timeframe: procedure

Successful retrieval of the Lotus Valve System if retrieval is attempted

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Device Performance Endpoint-Valve Retrieval, if Attempted	NA participants There were no attempts made to retrieve the valve.

SECONDARY outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

As determined by echocardiography

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Central Aortic Regurgitation None	10 participants
Central Aortic Regurgitation Trivial	1 participants
Central Aortic Regurgitation Mild	0 participants
Central Aortic Regurgitation Moderate or Severe	0 participants

SECONDARY outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

As determined by echocardiography

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Paravalvular Aortic Regurgitation None	8 participants
Paravalvular Aortic Regurgitation Trivial	1 participants
Paravalvular Aortic Regurgitation Mild	2 participants
Paravalvular Aortic Regurgitation Moderate or Severe	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Procedure

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Successful Access, Device Delivery, Deployment and Positioning and Retrieval of Delivery System	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of discharge or 7 days post procedure

Aortic valve area \>1.0 cm2 plus either a mean aortic valve gradient \<20 mmHg or peak velocity \<3m/sec, without moderate or severe prosthetic valve aortic regurgitation

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Intended Performance of the Lotus Valve	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: procedure

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Single Valve Implanted in the Proper Anatomical Location	11 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Major adverse cardiovascular or cerebrovascular events include all-cause mortality, periprocedural myocardial infarction ≤72 hours, major stroke, urgent/emergent conversion to surgery or repeat procedure for valve-related dysfunction

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
No Major Adverse Cardiovascular and Cerebrovascular Events Through Discharge	10 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

As determined by echocardiography

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Mean Aortic Valve Gradient	13.7 mm Hg Standard Deviation 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

As determined by echocardiography

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Aortic Valve Area	1.53 cm^2 Standard Deviation 0.18

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Death	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 hours

Peri-Procedural Myocardial Infarction (≤72 hours after the index procedure) * New ischemic symptoms (e.g., chest pain or shortness of breath), or new ischemic signs (e.g. ventricular arrhythmias, new or worsening heart failure, new ST-segment changes, hemodynamic instability, or imaging evidence of new loss of viable myocardium or new wall motion abnormality), AND * Elevated cardiac biomarkers (preferably creatine kinase-myoglobin band) within 72 h after the index procedure, consisting of two or more post-procedure samples that are \> 0.6 to 8 h apart with a 20% increase in the second sample and a peak value exceeding 10X the 99th percentile upper reference limit (URL), or a peak value exceeding 5X the 99th percentile URL with new pathological Q waves in at least 2 contiguous leads

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Peri-procedural Myocardial Infarction	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Confirmed with a Modified Rankin score \>/= 2 at 30 and 90 days

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Major Stroke	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Urgent/Emergent Conversion to Surgery or Repeat Procedure for Valve-related Dysfunction	0 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

* Any thoracic aortic dissection * Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, or compartment syndrome) leading to either death, need for significant blood transfusions (≥4 units), unplanned percutaneous or surgical intervention, or irreversible end-organ damage (e.g. hypogastric artery occlusion causing visceral ischemia or spinal artery injury causing neurologic impairment) * Distal embolization (non-cerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Major Vascular Complication	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
New Conduction Disturbances or Arrhythmias Requiring Permanent Pacemaker	4 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Life-threatening or Disabling Bleeding * Fatal bleeding OR * Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome OR * Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery OR * Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units Major Bleeding * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC AND * Does not meet criteria of life-threatening or disabling bleeding

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Bleeding Life-threatening or disabling	0 participants
Bleeding Major	2 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge or 7 days post-procedure, whichever comes first

Stage 2: Increase in serum creatinine to 200-300% (2.0-3.0 times increase compared with baseline). Stage 3: Increase in serum creatinine to ≥ 300% (\> 3 times increase compared with baseline) or serum creatinine of ≥ 4.0 mg/d (≥ 354 μmol/L) with an acute increase of at least 0.5 mg/dl (44 μmol/L). Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.

Outcome measures

Outcome measures
Measure	Lotus Valve System n=11 Participants Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Acute Kidney Injury - Stage 2 or 3	0 participants

Adverse Events

Lotus Valve System

Serious events: 6 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lotus Valve System n=11 participants at risk Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Cardiac disorders Atrioventricular block complete	18.2% 2/11 • Number of events 2 • After 1 year index procedure
Cardiac disorders Bradycardia	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Cardiac disorders Pericardial effusion	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Cardiac disorders Ventricular fibrillation	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Nervous system disorders Ischaemic stroke	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Renal and urinary disorders Renal failure acute	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Vascular disorders Haematoma	9.1% 1/11 • Number of events 1 • After 1 year index procedure

Other adverse events

Other adverse events
Measure	Lotus Valve System n=11 participants at risk Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
Blood and lymphatic system disorders Anaemia	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Cardiac disorders Bundle branch block left	63.6% 7/11 • Number of events 7 • After 1 year index procedure
Cardiac disorders Myocardial infarction	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • After 1 year index procedure
General disorders Chest discomfort	9.1% 1/11 • Number of events 1 • After 1 year index procedure
General disorders Pyrexia	9.1% 1/11 • Number of events 1 • After 1 year index procedure
General disorders Secretion discharge	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Immune system disorders Drug hypersensitivity	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Infections and infestations Otitis externa	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Infections and infestations Urinary tract infection	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Injury, poisoning and procedural complications Arterial injury	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Investigations Hepatic enzyme increased	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Nervous system disorders Dizziness	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Psychiatric disorders Confusional state	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Psychiatric disorders Delirium	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Skin and subcutaneous tissue disorders Petechiae	9.1% 1/11 • Number of events 1 • After 1 year index procedure
Vascular disorders Haematoma	27.3% 3/11 • Number of events 3 • After 1 year index procedure
Vascular disorders Peripheral artery dissection	9.1% 1/11 • Number of events 1 • After 1 year index procedure

Additional Information

Director of Clinical Trials, Valves

Boston Scientific Corporation

Phone: 408-370-1550

Results disclosure agreements

Principal investigator is a sponsor employee The Principal Investigator (PI) shall have the right to publish the results, provided that before publishing, the PI shall submit copies of any proposed publication or presentation to the Sponsor for review at least 45 days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.
Publication restrictions are in place

Restriction type: OTHER