AtriCure Minimally Invasive Surgical Ablation for Atrial... | NCT00571779

Studies
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIB

NCT00571779

Sponsor

AtriCure, Inc.

Status

Withdrawn

Last Update Posted

Feb 21, 2011Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Atrial Fibrillation

Interventions

AtriCure Bipolar System

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 10, 2007

First Submission Date that Met QC Criteria

Dec 10, 2007

First Posted Date

Dec 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2011

Last Update Posted Date

Feb 21, 2011Estimated

Description Module

Brief Summary

Feasibility study arm to evaluate the safety of adding the left atrial linear connecting lesions of the Cox-Maze lesion set to the current RESTORE SR II IDE study procedure of performing pulmonary vein isolation, selected left atrial autonomic ganglionated plexi (GP) ablation, and optional left atrial appendage (LAA) excision/exclusion on a beating heart for patients with permanent or persistent Atrial Fibrillation (AF).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
AtriCure Bipolar System	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of performing the operation by demonstrating the ability to consistently isolate the left and right pulmonary veins and to confirm conduction block across the roof, anterior and LAA linear lesions.
The primary safety endpoint will be determined by assessing the rate of serious adverse events.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient between 18 and 80 years of age
Patient with documented symptomatic persistent or permanent AF and failure or intolerance of one or more Class I or Class III antiarrhythmic drugs.
- Persistent AF: AF that is not self-terminating or is terminated electrically or pharmacologically.
- Longstanding AF: Persistent AF of 12 months (or longer) duration.
- Permanent AF: Longstanding AF in which electrical or pharmacological cardioversion has failed or has not been attempted.
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.

Exclusion Criteria:

Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
Myocardial infarction within 8 weeks.
Prior cardiac surgery.
Patient requires cardiac surgery for treatment other than for AF.
Class IV NYHA heart failure symptoms, unless due to uncontrolled AF
Cerebrovascular accident within previous 6 months
Known carotid artery stenosis greater than 80%
Evidence of significant active infection
Patient unable to undergo TEE
Pregnant woman
Patient requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
Presence of thrombus in the left atrium
Co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
Patient is enrolled in another cardiac clinical trial
Left ventricular ejection fraction < 30%
Left atrial transverse diameter >6.0
Patient has undergone previous thoracic targeted radiation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes