Trial Outcomes & Findings for Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach (NCT NCT02393885)

Last Updated: 2024-12-19

Results Overview

Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting \>30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed AADs at doses not exceeding those previously failed).

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit

Results posted on

2024-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Overall Study STARTED	90
Overall Study COMPLETED	85
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System n=90 Participants AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=5 Participants
Age, Categorical >=65 years	42 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	90 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment Netherlands	7 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit

Population: Modified Intent to Treat (mITT)

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System n=85 Participants AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Primary Effectiveness Endpoint	61 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: Safety Population

The primary safety endpoint is a composite endpoint consisting of any one or more of the events if they were adjudicated by the CEC to be serious adverse events (SAEs) and related to device/procedures as follows: 1. The AtriCure Bipolar System and/or the AtriClip Pro LAA Exclusion System, within 30 days following the epicardial surgical ablation procedure; or 2. The epicardial surgical ablation procedure within 30 days following the epicardial procedure; or 3. The endocardial index procedure (or a repeat endocardial ablation procedure performed during the blanking period) within 7 days following an endocardial ablation procedure.

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System n=90 Participants AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Primary Safety Endpoint	6 Participants

Adverse Events

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System

Serious events: 24 serious events

Other events: 23 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System n=90 participants at risk AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Cardiac disorders Acute myocardial infarction	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Atrial fibrillation	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Atrial flutter	3.3% 3/90 • Number of events 4 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Atrial tachycardia	2.2% 2/90 • Number of events 3 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Atrioventricular block	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Bradycardia	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Pulseless electrical activity	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Cardiac disorders Sick sinus syndrome	2.2% 2/90 • Number of events 2 • 24 months All adverse events that occurred within 24 months post procedure were collected
Gastrointestinal disorders Gastrointestinal haemorrhage	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Gastrointestinal disorders Intestinal obstruction	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Gastrointestinal disorders Large intestine polyp	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Infections and infestations Bursitis infective	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Infections and infestations Clostridium difficile colitis	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Infections and infestations Pneumococcal sepsis	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Infections and infestations Pneumonia	2.2% 2/90 • Number of events 2 • 24 months All adverse events that occurred within 24 months post procedure were collected
Infections and infestations Sepsis	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Injury, poisoning and procedural complications Atrio-oesophageal fistula	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Injury, poisoning and procedural complications Diaphragmatic injury	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Injury, poisoning and procedural complications Postoperative ileus	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Metabolism and nutrition disorders Fluid overload	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Metabolism and nutrition disorders Hyponatraemia	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Nervous system disorders Cerebrovascular accident	2.2% 2/90 • Number of events 2 • 24 months All adverse events that occurred within 24 months post procedure were collected
Nervous system disorders Hypoxic-ischaemic encephalopathy	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Nervous system disorders Ischaemic stroke	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Nervous system disorders Lumbar radiculopathy	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Nervous system disorders Metabolic encephalopathy	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Nervous system disorders Transient ischaemic attack	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Apnoea	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Pharyngeal haematoma	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Pulmonary mass	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Vascular disorders Air embolism	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Vascular disorders Aortic aneurysm	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected
Vascular disorders Femoral artery aneurysm	1.1% 1/90 • Number of events 1 • 24 months All adverse events that occurred within 24 months post procedure were collected

Other adverse events

Other adverse events
Measure	AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System n=90 participants at risk AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure. AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Cardiac disorders Pericarditis	5.6% 5/90 • Number of events 5 • 24 months All adverse events that occurred within 24 months post procedure were collected
General disorders Chest pain	3.3% 3/90 • Number of events 3 • 24 months All adverse events that occurred within 24 months post procedure were collected
General disorders Oedema peripheral	3.3% 3/90 • Number of events 3 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.4% 4/90 • Number of events 4 • 24 months All adverse events that occurred within 24 months post procedure were collected
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.4% 4/90 • Number of events 4 • 24 months All adverse events that occurred within 24 months post procedure were collected
Vascular disorders Hypertension	4.4% 4/90 • Number of events 4 • 24 months All adverse events that occurred within 24 months post procedure were collected

Additional Information

Nfii Ndikintum

AtriCure, Inc.

Phone: 1-513-755-4100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER