Trial Outcomes & Findings for The SOLACE-AU Clinical Trial (NCT NCT01675596)

Last Updated: 2019-04-16

Results Overview

The primary endpoint is a VARC-2 Composite. It comprises of 1. All cause mortality 2. All stroke 3. Life-threatening bleeding 4. Acute kidney injury - Stage 3 (including renal replacement therapy) 5. Coronary artery obstruction requiring intervention 6. Major vascular complications 7. Valve related dysfunction (requiring repeat procedure) A composite endpoint is an endpoint that is a combination of multiple components.

Recruitment status

COMPLETED

Study phase

Target enrollment

199 participants

Primary outcome timeframe

30 days

Results posted on

2019-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	TAVR With SAPIEN XT THV SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
Overall Study STARTED	199
Overall Study COMPLETED	191
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	TAVR With SAPIEN XT THV SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
Overall Study Death	6
Overall Study Exit with other reason	1
Overall Study Missed Visit	1

Baseline Characteristics

The SOLACE-AU Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAVR With SAPIEN XT THV n=199 Participants SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
Age, Continuous	85.5 Years STANDARD_DEVIATION 4.51 • n=5 Participants
Sex: Female, Male Female	108 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants
STS Score	5.9 units on a scale STANDARD_DEVIATION 2.59 • n=5 Participants
NYHA I/II	43 Participants n=5 Participants
NYHA III/IV	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	TAVR With SAPIEN XT THV n=199 Participants SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
VARC-2 Composite Safety Endpoint	12.1 percentage of patients

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	TAVR With SAPIEN XT THV n=199 Participants SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
All Cause Mortality	2.5 percentage of patients

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	TAVR With SAPIEN XT THV n=199 Participants SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
All Cause Mortality	8.5 percentage of participants

Adverse Events

TAVR With SAPIEN XT THV

Serious events: 73 serious events

Other events: 182 other events

Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure	TAVR With SAPIEN XT THV n=199 participants at risk SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
Investigations Abnormal lab value	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Dissection	2.0% 4/199 • Number of events 4 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Distal embolization (noncerebral)	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Failure of percutaneous access site closure	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Hematoma	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Pseudoaneurysm	1.5% 3/199 • Number of events 3 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Rupture	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Access site and access related vascular injury - Ventricular rupture (Apical rupture)	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Metabolism and nutrition disorders Anemia/Hemolytic anemia	2.0% 4/199 • Number of events 4 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Angina/Cardiac chest pain	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Arrhythmia/Conduction system injury (defect)	8.5% 17/199 • Number of events 21 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Vascular disorders Bleeding - Hemorrhage	4.0% 8/199 • Number of events 8 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Cardiac tamponade/Pericardial effusion	1.5% 3/199 • Number of events 3 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Device migration/malposition requiring intervention	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Injury, poisoning and procedural complications Embolization including air/calcific valve material or Thrombus	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Gastrointestinal disorders Gastro Intestinal event - Non-hemorrhagic	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Heart failure/CHF/Low output failure	3.0% 6/199 • Number of events 6 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Vascular disorders Hypertension	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Vascular disorders Hypotension	3.5% 7/199 • Number of events 7 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Infections and infestations Infection - Respiratory infection	2.5% 5/199 • Number of events 5 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Infections and infestations Infection - Urinary tract infection	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Myocardial Infarction	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Psychiatric disorders Mental state change (not neurological) - Confusion	1.5% 3/199 • Number of events 3 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Investigations Miscellaneous - Other	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Investigations Multi organ failure	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Nervous system disorders Neurological - Hemorrhagic stroke	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Nervous system disorders Neurological - Ischemic stroke	1.5% 3/199 • Number of events 3 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Nervous system disorders Neurological - Other	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Nervous system disorders Neurological - Other new neurological sign consistent with stroke	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Nervous system disorders Neurological - TIA	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Renal and urinary disorders Renal insufficiency or renal failure	2.0% 4/199 • Number of events 4 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Respiratory event - Aspiration	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Respiratory event - Dyspnea	1.5% 3/199 • Number of events 4 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Respiratory event - Other	1.0% 2/199 • Number of events 2 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Respiratory event - Pulmonary edema	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Respiratory, thoracic and mediastinal disorders Respiratory event - Respiratory failure	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Vascular disorders Syncope	1.5% 3/199 • Number of events 3 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Investigations Unknown cause of death	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Investigations Other	5.0% 10/199 • Number of events 11 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Renal and urinary disorders Genito-Urinary event - Non-hemorrhagic	0.50% 1/199 • Number of events 1 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Cardiac arrest	1.0% 2/199 • Number of events 3 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.

Other adverse events

Other adverse events
Measure	TAVR With SAPIEN XT THV n=199 participants at risk SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems. TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects
Injury, poisoning and procedural complications Access site and access related vascular injury - Hematoma	25.6% 51/199 • Number of events 58 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Metabolism and nutrition disorders Anemia/Hemolytic anemia	10.6% 21/199 • Number of events 21 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Arrhythmia/Conduction system injury (defect)	32.7% 65/199 • Number of events 91 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Vascular disorders Bleeding - Hemorrhage	29.1% 58/199 • Number of events 68 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Vascular disorders Hypotension	14.1% 28/199 • Number of events 29 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Musculoskeletal and connective tissue disorders Musculoskeletal - Pain	9.0% 18/199 • Number of events 19 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Investigations Other	50.3% 100/199 • Number of events 160 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Blood and lymphatic system disorders Abnormal Labs	6.5% 13/199 • Number of events 15 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Renal and urinary disorders Genito-Urinary event - Non-hemorrhagic	6.5% 13/199 • Number of events 13 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Cardiac disorders Hypertension	7.5% 15/199 • Number of events 15 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Infections and infestations Infection - Respiratory infection	5.5% 11/199 • Number of events 12 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Psychiatric disorders Mental state change (not neurological) - Confusion	5.5% 11/199 • Number of events 12 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
Renal and urinary disorders Renal insufficiency or renal failure	6.0% 12/199 • Number of events 12 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.
General disorders Miscellaneous - Other	5.5% 11/199 • Number of events 11 • All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented. All Adverse Events are site-reported.

Additional Information

Tenley Koepnick

Edwards Lifesciences

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place