Trial Outcomes & Findings for The PEARL 8.0 Post-Approval Study (NCT NCT01845103)

NCT ID: NCT01845103

Last Updated: 2016-10-06

Results Overview

• Recruitment status: TERMINATED
• Target enrollment: 1 participants
• Primary outcome timeframe: 30 day
• Results posted on: 2016-10-06

Participant Flow

Participant milestones

Measure	PEARL 8.0 Received TMR with PEARL 8.0
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The PEARL 8.0 Post-Approval Study

Baseline characteristics by cohort

Measure	PEARL 8.0 n=1 Participants
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	1 Participants n=5 Participants
Age, Continuous	75 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 day

Outcome measures

Measure	PEARL 8.0 n=1 Participants
Mortality	0 percentage of participants

SECONDARY outcome

Timeframe: 30 day

MACCE includes:

Cardiac related death, CVA, Myocardial Infarction, Serious arrhythmia, CHF

Outcome measures

Measure	PEARL 8.0 n=1 Participants
Major Adverse Coronary and Cerebrovascular Events (MACCE)	0 percentage of participants

Adverse Events

PEARL 8.0

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	PEARL 8.0 n=1 participants at risk
Respiratory, thoracic and mediastinal disorders Serious Adverse Event required hospitalization	100.0% 1/1 • Number of events 1 • 30 days

Other adverse events

Adverse event data not reported

Additional Information

Scott Capps, MS/ Vice President, Clinical Research

CryoLife, Inc.

Phone: 800-438-8285

Email: clinicaltrialregistration@cryolife.com

Results disclosure agreements

• Principal investigator is a sponsor employee Site and Investigator agree not to publish or present results prior to Sponsor's final report, but in no event shall Site or Investigator be restricted after the expiration of 12m from Project completion. Publication or disclosure made by Site or Investigator shall not contain Sponsor Confidential Information (CI) and text shall be submitted for Sponsor CI review and comment 30d prior to submission or disclosure and can be deferred, not exceeding 90d for the Sponsor to protect its rights in CI.
• Publication restrictions are in place

Restriction type: OTHER