Trial Outcomes & Findings for Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP) (NCT NCT01661205)

Last Updated: 2017-05-17

Results Overview

Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

30 days post-index procedure or hospital discharge

Results posted on

2017-05-17

Participant Flow

First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.

Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.

Participant milestones

Participant milestones
Measure	AtriCure Bipolar System Combined With a Catheter Ablation Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	AtriCure Bipolar System Combined With a Catheter Ablation Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Overall Study Physician Decision	2

Baseline Characteristics

Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=26 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants
Age, Continuous	61.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	24 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
Height	71.0 inches STANDARD_DEVIATION 3.9 • n=5 Participants
Weight	220.9 Lbs. STANDARD_DEVIATION 35.8 • n=5 Participants
Body Mass Index (BMI)	30.8 kg/m2 STANDARD_DEVIATION 3.9 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-index procedure or hospital discharge

Population: Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=25 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.	3 Participants

PRIMARY outcome

Timeframe: 12 month follow-up

Population: Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.

Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=23 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number of Subjects With Absence of Atrial Fibrillation	18 Participants

SECONDARY outcome

Timeframe: 12 month follow-up

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=25 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number Subjects With Serious Device or Procedure Related Adverse Event Rate Epicardial AF Procedure	6 Participants
Number Subjects With Serious Device or Procedure Related Adverse Event Rate Investigational Device	0 Participants

SECONDARY outcome

Timeframe: Day 0

Defined as subject meeting all of the following criteria upon completion of the index-EP procedure 1. Isolation/block of all pulmonary veins (e.g. 4 of 4 veins); 2. Bi-directional cavotricuspid isthmus block; 3. Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines); 4. Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=25 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number of Subjects With Acute Procedure Success	19 Participants

SECONDARY outcome

Timeframe: 6 and 12 month follow-up

AF free with or without the need of antiarrhythmic drugs

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=23 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number of Subject Without Atrial Fibrillation 6-Months Follow-Up	17 Participants
Number of Subject Without Atrial Fibrillation 12-Months Follow-Up	19 Participants

SECONDARY outcome

Timeframe: 12 month follow-up

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=25 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number of Subjects With Reinterventions	8 Participants

SECONDARY outcome

Timeframe: 12 month follow-up

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=25 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Number of Subjects With Direct Current (DC) Cardioversion	6 Participants

SECONDARY outcome

Timeframe: 12 month follow-up

Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline. 1. This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology. 2. The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology. 3. Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .

Outcome measures

Outcome measures
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=23 Participants Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores Checklist Frequency Score	-16.3 percentage of from baseline Standard Deviation 8.6
Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores Checklist Severity Score	-12.6 percentage of from baseline Standard Deviation 7.0

Adverse Events

AtriCure Bipolar System Combined With a Catheter Ablation

Serious events: 12 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=26 participants at risk Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Cardiac disorders Atrial fibrillation	3.8% 1/26 • Number of events 1 • 24-months
Cardiac disorders Atrial tachycardia	3.8% 1/26 • Number of events 1 • 24-months
Cardiac disorders Atrioventricular block complete	3.8% 1/26 • Number of events 1 • 24-months
Cardiac disorders Cardiac tamponade	3.8% 1/26 • Number of events 1 • 24-months
Cardiac disorders Pericarditis	7.7% 2/26 • Number of events 2 • 24-months
Cardiac disorders Ventricular fibrillation	3.8% 1/26 • Number of events 1 • 24-months
Gastrointestinal disorders Multi-organ failure	3.8% 1/26 • Number of events 1 • 24-months
Injury, poisoning and procedural complications Device lead damage	3.8% 1/26 • Number of events 1 • 24-months
Injury, poisoning and procedural complications Procedural hypotension	3.8% 1/26 • Number of events 1 • 24-months
Investigations Liver function test abnormal	3.8% 1/26 • Number of events 1 • 24-months
Metabolism and nutrition disorders Fluid overload	3.8% 1/26 • Number of events 1 • 24-months
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	3.8% 1/26 • Number of events 1 • 24-months
Nervous system disorders Convulsion	3.8% 1/26 • Number of events 1 • 24-months
Nervous system disorders Unresponsive to stimuli	3.8% 1/26 • Number of events 1 • 24-months
Nervous system disorders Vocal cord paralysis	3.8% 1/26 • Number of events 1 • 24-months
Renal and urinary disorders Renal failure	7.7% 2/26 • Number of events 2 • 24-months
Respiratory, thoracic and mediastinal disorders Atelectasis	3.8% 1/26 • Number of events 1 • 24-months
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	7.7% 2/26 • Number of events 2 • 24-months
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 1/26 • Number of events 1 • 24-months
Surgical and medical procedures Ankle operation	3.8% 1/26 • Number of events 1 • 24-months
Surgical and medical procedures Heart valve operation	3.8% 1/26 • Number of events 1 • 24-months
Vascular disorders Thrombophlebitis	3.8% 1/26 • Number of events 1 • 24-months

Other adverse events

Other adverse events
Measure	AtriCure Bipolar System Combined With a Catheter Ablation n=26 participants at risk Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
Cardiac disorders Atrial fibrillation	7.7% 2/26 • Number of events 4 • 24-months
Cardiac disorders Pericardial effusion	23.1% 6/26 • Number of events 6 • 24-months
Metabolism and nutrition disorders Fluid overload	7.7% 2/26 • Number of events 2 • 24-months
Renal and urinary disorders Renal Failure	7.7% 2/26 • Number of events 3 • 24-months
Respiratory, thoracic and mediastinal disorders Diaphragmatic paralysis	7.7% 2/26 • Number of events 2 • 24-months
Vascular disorders Deep vein thrombosis	7.7% 2/26 • Number of events 2 • 24-months

Additional Information

Vice President, Clinical Operations

AtriCure, Inc.

Phone: 513-755-4562

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place