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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01246466
First received: November 22, 2010
Last updated: June 16, 2014
Last verified: June 2014

November 22, 2010
June 16, 2014
November 2010
December 2012   (final data collection date for primary outcome measure)
  • composite of pre-specified safety endpoints occurring in the first 30 days post-index procedure or hospital discharge, whichever is longer. [ Time Frame: Within the first 30 days post-index procedure or hospital discharge ] [ Designated as safety issue: Yes ]
  • Absence of atrial fibrillation [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    Absence of atrial fibrillation (AF) at twelve month follow-up based on an auto trigger event monitor, while off all Class I and III antiarrhythmic therapy.
Same as current
Complete list of historical versions of study NCT01246466 on ClinicalTrials.gov Archive Site
  • Overall Serious Device or Procedure Related Adverse Event Rate [ Time Frame: 12 month follow-up ] [ Designated as safety issue: Yes ]
  • Acute Procedure Success [ Time Frame: Upon completion of the index procedure ] [ Designated as safety issue: No ]
  • Absence of atrial fibrillation [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Absence of atrial fibrillation after the 3 month blanking period through twelve month follow-up based on auto trigger event monitor.
  • Incidence of Reintervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of DC cardioversion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Improvement in AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Improvement in AF Symptom Checklist Frequency and Severity Scores.
  • Duration of procedure [ Time Frame: index procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dual Epicardial Endocardial Persistent Atrial Fibrillation (AF) Study
Feasibility Trial of a Hybrid Approach for Treatment of Patients With Persistent or Longstanding Persistent Atrial Fibrillation With Radiofrequency Ablation

The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac surgery is using the AtriCure Bipolar System combined with a catheter ablation procedure in treating AF, and how effective this combined procedure is using the AtriCure System in treating AF. The AtriCure Bipolar System will be used to perform the less invasive cardiac surgery and a standard electrophysiology catheter, currently available, will be used to perform the catheter ablation procedure. This surgical procedure is considered less invasive because it is done through tiny surgical punctures on the sides of the chest near the ribs instead of one large surgical incision of the breast bone to completely open the chest and access the heart, and it also avoids the need for the heart-lung bypass machine.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
Device: Hybrid ablation procedure
AtriCure Bipolar System plus a catheter ablation
Experimental: AtriCure Bipolar System combined with a catheter ablation
procedure using the AtriCure Bipolar System plus a catheter ablation
Intervention: Device: Hybrid ablation procedure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age > 18 years
  2. Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue) persistent or longstanding persistent AF Persistent
  3. Patient is willing and able to provide written informed consent.
  4. Patient has a life expectancy of at least 2 years.
  5. Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

  1. Prior Cardiothoracic Surgery.
  2. Patient has NYHA Class IV heart failure.
  3. Evidence of underlying structural heart disease requiring surgical treatment.
  4. Ejection fraction < 30%
  5. Measured left atrial diameter > 6.0 cm
  6. Renal Failure
  7. Stroke within previous 6 months.
  8. Known carotid artery stenosis greater than 80%.
  9. Evidence of significant active infection or endocarditis.
  10. Pregnant woman or women desiring to become pregnant in the next 24 months.
  11. Presence of thrombus in the left atrium determined by echocardiography.
  12. History of blood dyscrasia.
  13. Contraindication to anticoagulation, based on Investigator's opinion.
  14. Mural thrombus or tumor.
  15. Moderate to Severe COPD
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01246466
CP2009-1
Yes
AtriCure, Inc.
AtriCure, Inc.
Not Provided
Not Provided
AtriCure, Inc.
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP