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

NCT00950092 | Terminated DMC

• 1 other identifier: VAL-1116(C)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Atrial Fibrillation

Keywords

AF; atrial fibrillation; ablation; surgical ablation; afib; coagulation; RF; epicardial; Arrhythmias

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.

  9 months

Study Arms (1)

Treatment

OTHER

Device: Numeris-AF Tethered Coagulation System with VisiTrax

Interventions

Numeris-AF Tethered Coagulation System with VisiTrax DEVICE

Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System

Also known as: RF Ablation, Coagulation of cardiac tissue, nContact Surgical

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• nContact Surgical Inc.: lead

Study Sites (2)

Venice Regional Medical Center

Venice, Florida, 34285-3298, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Thrombosis; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Edward Garrett, M.D.

  Baptist Memorial Hospital - Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2009
• First Posted: July 31, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 3, 2014

Record last verified: 2013-09

Locations

US (2)