N/A
N=26
Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01661205 ↗Enrolled (actual)
26
Serious AEs
46.2%
Results posted
May 2017
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ablation procedure staged catheter ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer. |
3 | — |
| PRIMARY Number of Subjects With Absence of Atrial Fibrillation |
18 | — |
| SECONDARY Number Subjects With Serious Device or Procedure Related Adverse Event Rate |
6; 0 | — |
| SECONDARY Number of Subjects With Acute Procedure Success |
19 | — |
| SECONDARY Number of Subject Without Atrial Fibrillation |
17; 19 | — |
| SECONDARY Number of Subjects With Reinterventions |
8 | — |
| SECONDARY Number of Subjects With Direct Current (DC) Cardioversion |
6 | — |
| SECONDARY Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores |
-16.3; -12.6 | — |
Summary
The purpose of this study is to assess the safety and technical feasibility of treating subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar System, with mapping and additional lesion creation/ gap closure (as needed) provided by currently approved catheter technology, when the epicardial and endocardial phases are performed in a staged manner within 1-10 days apart, during the same hospitalization.
Eligibility Criteria
Inclusion Criteria
- Age > 18 year
- Patients with symptomatic persistent or longstanding persistent AF refractory to a minimum of one Class I or III antiarrhythmic drug (AAD).
- Patients with failed catheter ablation attempts are eligible if the patients are symptomatic with persistent or longstanding persistent AF. (catheter ablation procedure must be more than 3 months prior to index procedure)
- Life expectancy of at least two years
- Patient will and able to provide informed consent
- Patient is willing and able to attend the scheduled follow-up visits
Exclusion Criteria
- Prior Cardiothoracic Surgery
- Patient has NYHA (New York Heart Association) Class IV heart failure
- Evidence of underlying structural heart disease requiring surgical treatment
- Surgical procedure within the 30 days prior to the index procedure
- Ejection fraction 6.0 cm
- Renal Failure
- Stroke within previous 6 months
- Known carotid artery stenosis greater than 80%
- Evidence of significant active infection or endocarditis
- Pregnant woman or women desiring to become pregnant in the next 24 months
- Presence of thrombus in the left atrium determined by echocardiography
- History of blood dyscrasia
- Contraindication to anticoagulation, based on Investigator's opinion
- Mural thrombus or tumor
- Moderate to Severe COPD
Data sourced from ClinicalTrials.gov (NCT01661205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.