Trial Outcomes & Findings for RESPOND Post Market Study (NCT NCT02031302)

NCT ID: NCT02031302

Last Updated: 2021-11-19

Results Overview

The primary endpoint is all-cause mortality at 30 days after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). All-cause mortality at 30 days after the implant procedure will be compared to a pre-specified performance goal.

Recruitment status

COMPLETED

Target enrollment

1064 participants

Primary outcome timeframe

30 Days

Results posted on

2021-11-19

Participant Flow

There were 1014 subjects enrolled at 41 centers in Germany, UK, Italy, Colombia, Finland, The Netherlands, Poland, Spain, Israel, New Zealand, Norway, Sweden and Switzerland between 27 May 2014 and 01 Feb 2016. 50 subjects were enrolled in the cohort with the Lotus Depth Guard valve between 13 Jun 2016 and 31 Oct 2016.

Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.

Participant milestones

Participant milestones
Measure	Lotus Valve All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement. These are the 1 year outcome.	Lotus With Depth Guard All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement. These are the 30 days outcome. Study ended at 30 days. No 1 year data collected.
Overall Study STARTED	1014	50
Overall Study COMPLETED	850	50
Overall Study NOT COMPLETED	164	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotus Valve All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement. These are the 1 year outcome.	Lotus With Depth Guard All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement. These are the 30 days outcome. Study ended at 30 days. No 1 year data collected.
Overall Study Death	115	0
Overall Study Not treated with study valve system	18	0
Overall Study Missed Follow Up	27	0
Overall Study Lost to Follow-up	4	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotus Valve n=996 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard n=50 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Total n=1046 Participants Total of all reporting groups
Age, Continuous	80.8 years STANDARD_DEVIATION 6.5 • n=996 Participants	80.9 years STANDARD_DEVIATION 8.2 • n=50 Participants	80.8 years STANDARD_DEVIATION 6.6 • n=1046 Participants
Sex: Female, Male Female	506 Participants n=996 Participants	23 Participants n=50 Participants	529 Participants n=1046 Participants
Sex: Female, Male Male	490 Participants n=996 Participants	27 Participants n=50 Participants	517 Participants n=1046 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
European System for Cardiac Operative Risk Evaluation (EuroSCORE 2011)	8.0 units on a scale STANDARD_DEVIATION 8.4 • n=996 Participants	3.3 units on a scale STANDARD_DEVIATION 1.7 • n=50 Participants	7.8 units on a scale STANDARD_DEVIATION 8.2 • n=1046 Participants
New York Heart Association (NYHA) Classification NYHA I	34 participants n=996 Participants	1 participants n=50 Participants	35 participants n=1046 Participants
New York Heart Association (NYHA) Classification NYHA II	248 participants n=996 Participants	22 participants n=50 Participants	270 participants n=1046 Participants
New York Heart Association (NYHA) Classification NYHA III	577 participants n=996 Participants	25 participants n=50 Participants	602 participants n=1046 Participants
New York Heart Association (NYHA) Classification NYHA IV	66 participants n=996 Participants	1 participants n=50 Participants	67 participants n=1046 Participants
New York Heart Association (NYHA) Classification Not done	71 participants n=996 Participants	1 participants n=50 Participants	72 participants n=1046 Participants
Society of Thoracic Surgeons (STS) Risk Score	6.0 units on a scale STANDARD_DEVIATION 6.9 • n=996 Participants	4.4 units on a scale STANDARD_DEVIATION 3.1 • n=50 Participants	5.9 units on a scale STANDARD_DEVIATION 6.6 • n=1046 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: The primary endpoint analysis is based on the ITT population (1014) through 30 days; 9 subjects out of 1014 subjects are excluded from the analysis because they don't have sufficient follow up, their last follow up days are less than 23 days.

Outcome measures

Outcome measures
Measure	Lotus Valve n=1005 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard n=50 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
All-cause Mortality	26 Participants	0 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: The primary endpoint analysis is based on the ITT population (1014) through 1 year; 12 subjects out of 1014 subjects are excluded from the analysis because they don't have sufficient follow up, their last follow up days are less than 320 days.

The primary endpoint is all-cause mortality at 1 year after the implant procedure. The primary safety endpoint will be evaluated on an intention-to-treat (ITT) basis (all subjects enrolled, whether or not a Lotus Valve is implanted). A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 4 additional patients died but were not treated with the study valve system (ITT population). The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

Outcome measures

Outcome measures
Measure	Lotus Valve n=1002 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
All-cause Mortality	120 Participants	—

SECONDARY outcome

Timeframe: 30 Days and 1 year

Population: The Safety composite of all-cause mortality and disabling stroke analysis is based on the as treated population for the Lotus valve arm (996) through 1 year; 8 subjects out of 996 subjects are excluded from the analysis because they don't have sufficient follow up; their last follow up days are less than 320 days.

All subjects who are candidates for transcatheter aortic valve implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve will be evaluated for enrollment in this study (as treated population) The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

Outcome measures

Outcome measures
Measure	Lotus Valve n=988 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard n=50 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke 30 day outcome	41 Participants	1 Participants
Percentage of Participants With Events Included in the Safety Composite Endpoint of All-Cause Mortality and Disabling Stroke 1 year outcome	135 Participants	0 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 2 days

Population: The In-hospital till discharge analysis is based on the as treated population for the Lotus valve arm (996). In the Lotus with Depth Guard arm are all patients treated with the device.

In-hospital mortality till discharge

Outcome measures

Outcome measures
Measure	Lotus Valve n=996 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard n=50 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
In-hospital Mortality	18 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year. 443 patients had no Echo analysis and therefore no data available.

The VARC efficacy composite at 1 year, including all-cause mortality; all stroke (disabling and non-disabling); re-hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); and prosthetic valve-related dysfunction (mean aortic valve gradient ≥20 mmHg, effective orifice area (EOA) ≤0.9-1.1 cm2 and/or Doppler velocity index (DVI) \<0.35 m/s, AND/OR moderate or severe prosthetic valve aortic regurgitation)

Outcome measures

Outcome measures
Measure	Lotus Valve n=553 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Percentage of Participants With Events Included in the VARC Efficacy Composite Endpoint	200 Participants	—

SECONDARY outcome

Timeframe: 1 Year

Population: The analysis of patients with valve safety composite outcomes at 1 year is based on the as treated population for the Lotus valve arm (996) through 1 year; 8 subjects out of 996 subjects are excluded from the analysis because they don't have sufficient follow up; their last follow up days are less than 320 days.

Time related valve safety composite outcomes at 1 year, including structural valve deterioration (valve-related dysfunction requiring repeat procedure \[TAVI or SAVR\]); prosthetic valve endocarditis; prosthetic valve thrombosis; thromboembolic events (e.g. stroke) and VARC bleeding, unless clearly unrelated to valve therapy based on investigator assessment (e.g. trauma). The Lotus Valve cohort is an ongoing study in it's 4 year follow up. The Lotus with Depth Guard cohort ended after 30 day follow up, therefore we have no data at 1 year.

Outcome measures

Outcome measures
Measure	Lotus Valve n=988 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Patients With Valve Safety Composite Outcomes at 1 Year	219 Participants	—

SECONDARY outcome

Timeframe: 30 Days

Population: The analysis of patients with valve safety composite outcomes at 30 days based on the as treated population for the Lotus valve arm (996) through 30 days. In the Lotus with Depth Guard arm are all patients treated with the device.

Patients with VARC safety composite outcomes at 30 days. VARC safety composite endpoints are defined as: * Life-threatening bleeding * Acute kidney injury-Stage 2 or 3 (including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR) * New conduction disturbances (LBBB, AVB, RBBB) and need for permanent pacemaker implantation

Outcome measures

Outcome measures
Measure	Lotus Valve n=996 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard n=50 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Patients With VARC Safety Composite Outcomes at 30 Days	334 Participants	10 Participants

SECONDARY outcome

Timeframe: Duration of hospital stay, an expected average of 2 days

Population: 62 patients had no data available for the analysis in the Lotus Valve arm. 13 patients had no data for the analysis in the Lotus with Depth Guard arm.

Grade of paravalvular aortic valve regurgitation pre-discharge as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory. The moderate and severe paravalvular aortic regurgitation rate will be compared to a pre-specified performance goal. We don't have a powered analysis for the PVL for RESPOND study.

Outcome measures

Outcome measures
Measure	Lotus Valve n=934 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard n=37 Participants All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Patients With Moderate and Severe Paravalvular Aortic Valve Regurgitation	179 Participants	13 Participants

Adverse Events

Lotus Valve (30 Day Follow Up)

Serious events: 426 serious events

Other events: 96 other events

Deaths: 22 deaths

Lotus Valve (1 Year Follow Up)

Serious events: 525 serious events

Other events: 99 other events

Deaths: 116 deaths

Lotus With Depth Guard (30 Day Follow Up)

Serious events: 14 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Lotus Valve (30 Day Follow Up) n=1014 participants at risk All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus Valve (1 Year Follow Up) n=1014 participants at risk All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus Valve. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.	Lotus With Depth Guard (30 Day Follow Up) n=50 participants at risk All subjects who are candidates for Transcatheter Aortic Valve Implantation (TAVI), signed the Informed Consent Form (ICF) and are selected to receive a Lotus with Depth Guard. Lotus Valve System: The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area \[AVA\] of \<1.0 cm2 or index of \<0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
Cardiac disorders Bundle branch block left	8.4% 85/1014 • Number of events 86 • 1 year for the LOTUS valve group. The Lotus Depth guard group was only assessed up to 30 days. Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.	8.7% 88/1014 • Number of events 89 • 1 year for the LOTUS valve group. The Lotus Depth guard group was only assessed up to 30 days. Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.	8.0% 4/50 • Number of events 4 • 1 year for the LOTUS valve group. The Lotus Depth guard group was only assessed up to 30 days. Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.
General disorders Catheter site haematoma	1.1% 11/1014 • Number of events 11 • 1 year for the LOTUS valve group. The Lotus Depth guard group was only assessed up to 30 days. Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.	1.1% 11/1014 • Number of events 11 • 1 year for the LOTUS valve group. The Lotus Depth guard group was only assessed up to 30 days. Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.	6.0% 3/50 • Number of events 3 • 1 year for the LOTUS valve group. The Lotus Depth guard group was only assessed up to 30 days. Lotus Valve cohort: 1 subject had the 1 year visit on 25SEP2015, but died on 02OCT2015, that's why the disposition table only shows 115 subjects died prior to 1 year Follow-up performed . A total of 116 subjects died through 1 year (365 days) post procedure (as treated population). 120 of 1002 patients died according to the ITT population.

Additional Information

Blessie Concepcion, Director Clinical Trials

Boston Scientific Corp.

Phone: 408-385-8604

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor
Publication restrictions are in place

Restriction type: OTHER