nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF

Atrial Fibrillation Clinical Trial

Official title:

Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00950092
• Other study ID #: VAL-1116(C)
• Status: Terminated
• Phase: N/A
• First received: July 29, 2009
• Last updated: April 2, 2014
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: September 2013
• Source: nContact Surgical Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.

Description:

The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age > 18 years; < 80 years

• Left atrium =< 6.0 cm

• Documented persistent or longstanding persistent AF

• History of AF =< 10 years

• Scheduled for a concomitant cardiac procedure

• Coronary bypass surgery (CABG)

• Mitral valve repair/replacement

• Aortic valve replacement

• ASD repair

• Tricuspid valve repair/replacement

• Myxoma

• Any combination of the above procedures

• Provided written informed consent

Exclusion Criteria:

• Left atrial size > 6.0 cm (pre-op TTE - parasternal 4 chamber view)

• History of AF > 10 years

• Left ventricular ejection fraction < 30%

• Pregnant or planning to become pregnant during study

• Co-morbid medical conditions that limit one year life expectancy

• History of coagulopathy

• Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)

• Previous cardiac surgery

• History of pericarditis

• Previous cerebrovascular accident (CVA)

• Patients who have active infection or sepsis

• Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance

• Patients who are being treated for ventricular arrhythmias

• Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)

• Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment.

• Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Numeris-AF Tethered Coagulation System with VisiTrax
Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System

Locations

Country	Name	City	State
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Venice Regional Medical Center	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
nContact Surgical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.		9 months	Yes
Secondary	Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.		9 months	Yes
Secondary	Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.		9 months	Yes