Trial Outcomes & Findings for Evaluation Of New Onset Postoperative Atrial Fibrillation (NCT NCT01247974)

Last Updated: 2023-07-27

Results Overview

A composite endpoint consisting of the following procedure- related serious adverse events occurring within 30 days postprocedure: * Death * Myocardial Infarction (MI) * Stroke * Mediastinal Reoperation * Percutaneous Coronary Intervention (PCI)

Recruitment status

COMPLETED

Study phase

Target enrollment

439 participants

Primary outcome timeframe

30 days postprocedure

Results posted on

2023-07-27

Participant Flow

One subject, Subject 011-006, was randomized in error to the ECM treatment group, but did not provide informed consent. This deviation was discovered prior to the surgery.

Participant milestones

Participant milestones
Measure	CorMatrix® ECM® CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure	Control Pericardium is not closed
Overall Study STARTED	217	222
Overall Study COMPLETED	191	203
Overall Study NOT COMPLETED	26	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation Of New Onset Postoperative Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CorMatrix® ECM® n=217 Participants CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure	Control n=222 Participants No closure of pericardium	Total n=439 Participants Total of all reporting groups
Age, Customized 18Y and older	217 participants n=5 Participants	222 participants n=7 Participants	439 participants n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	169 Participants n=7 Participants	335 Participants n=5 Participants
Region of Enrollment United States	217 participants n=5 Participants	222 participants n=7 Participants	439 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days postprocedure

Population: Performed with the FAS population using multiple imputation methods to impute values for missing or incomplete data. FAS population was defined as subjects in the ITT population who had CABG surgery and received their assigned treatment.

Outcome measures

Outcome measures
Measure	CorMatrix ECM for Pericardial Closure n=217 Participants Pericardial closure with CorMatrix ECM	Control n=222 Participants No Pericardial Closure
Primary Safety Endpoint	3.9 percentage of participants	3.6 percentage of participants

PRIMARY outcome

Timeframe: 7 days postoperatively or hospital discharge, whichever is sooner

Population: Primary analysis was based upon the ITT population using multiple imputation to impute missing values. The ITT population was defined as all subjects who provided informed consent and were randomized in the trial.

Rate of new onset postoperative atrial fibrillation during the first seven days postoperatively or prior to hospital discharge, whichever was sooner.

Outcome measures

Outcome measures
Measure	CorMatrix ECM for Pericardial Closure n=217 Participants Pericardial closure with CorMatrix ECM	Control n=222 Participants No Pericardial Closure
Primary Effectiveness Endpoint	40.0 percentage of participants	35.9 percentage of participants

Adverse Events

CorMatrix ECM

Serious events: 76 serious events

Other events: 190 other events

Deaths: 0 deaths

Control

Serious events: 54 serious events

Other events: 189 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CorMatrix ECM n=208 participants at risk CorMatrix ECM for Pericardial Closure	Control n=220 participants at risk Pericardium is not closed
Cardiac disorders Atrial fibrillation	5.8% 12/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	5.0% 11/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Cardiac disorders Angina pectoris	4.8% 10/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	2.7% 6/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Cardiac disorders Cardiac failure congestive	3.4% 7/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	2.7% 6/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
General disorders Event led to Death	3.4% 7/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	4.5% 10/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Infections and infestations Pneumonia	2.4% 5/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	0.91% 2/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Infections and infestations Urinary tract infection	1.4% 3/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	1.4% 3/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Nervous system disorders Cerebrovascular accident	1.4% 3/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	1.8% 4/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Renal and urinary disorders Renal failure acute	2.9% 6/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	1.8% 4/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.3% 11/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	1.4% 3/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.8% 8/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	1.8% 4/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.
Vascular disorders Hypotension	1.9% 4/208 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.	0.45% 1/220 • 2 years The adverse events are summarized using the Full Analysis Set population, which includes 428 subjects (208 subjects in the ECM group and 220 subjects in the control group. AEs were only collected from the treated population.

Other adverse events

Additional Information

Director, Clinical Development

CorMatrix Cardiovascular

Phone: 240-247-1170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multi-site publication is not submitted within twenty-four (24) months after conclusion of the Study at all sites, Institution and/or the Principal Investigator may publish the results from Institution's site individually, subject to Sponsor's rights
Publication restrictions are in place

Restriction type: OTHER