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Atrial Fibrillation Ablation and Autonomic Modulation Via Thorascopic Surgery

NCT01091389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-04-25

No results posted yet for this study

Summary

This study aims at investigating the role of autonomic modulation of AF. Therefore, totally thoracoscopic PV isolation with additional ablation of ganglionated plexi (GP) will be studied against PV isolation alone. Two groups of patients (paroxysmal AF with or without structural heart disease and persistent AF with or without heart disease) of 110 patients each will be studied.

Conditions

Interventions

PROCEDURE

Totally Thoracoscopic PV isolation

Surgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF.

Sponsors & Collaborators

  • Netherlands Heart Foundation

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • J.R. De Groot, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-02-23
Completion
2017-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT01091389 on ClinicalTrials.gov