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Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation

NCT02344394 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-10-03

No results posted yet for this study

Summary

The overall objective of the study is to compare and assess the clinical outcomes of the standard of care hybrid ablation using epicardial ablation in conjunction with endocardial PVI alone versus epicardial ablation in conjunction with endocardial ablation using PVI with additional RF ablation in a randomized, prospective population of patients with persistent AF of at least 6 months duration. All devices that are used are being utilized under the approved labeling of the devices.

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Medtronic Cryoballoon

For endocardial pulmonary vein Isolation, an Arctic Front Advance Cardiac CryoAblation catheter (Medtronic, Mounds view, MN, USA) will be used.

DEVICE

Thermocool Catheter

For mapping and ablation from endocardium a 3.5 mm irrigated tip catheter (Navistar Thermocool SmartTouch Unidirectional Navigation Catheter, Biosense Webster, Diamond Bar, CA, USA) will be used.

DEVICE

nContact

For Epicardial Ablation (the surgical portion of the Hybrid procedure), we will use the VisiTrax cardiac ablation device (nContact, Morrisville, NC, USA).

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jasbir S Sra, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-12-13
Completion
2017-12-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344394 on ClinicalTrials.gov