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Atrial Fibrillation Progression Trial

NCT01570361 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2025-02-04

Study results available
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Summary

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

Conditions

Interventions

DEVICE

Catheter Ablation

Treat subjects with Paroxysmal Atrial Fibrillation (PAF)

DRUG

Drug Treatment

Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Principal Investigators

  • Karl-Heinz Kuck, MD · Asklepios Klinik St. Georg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-13
Primary Completion
2018-12-19
Completion
2018-12-19
FDA Device
Yes

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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 NCT01570361 on ClinicalTrials.gov