CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 210 enrolled
Drug / intervention
Class I or III Antiarrhythmic Medications +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00514735
NCT00514735Phase 3Completed
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Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Aug 10, 2007·Updated Oct 16, 2018

In Brief

A Phase 3 clinical trial evaluating Medtronic Cardiac Ablation System and Class I or III Antiarrhythmic Medications for Atrial Fibrillation. Completed, enrolled 210 participants across 24 sites in 2 countries.

Detailed Summary

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesNetherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 10, 2007
Enrollment StartMay 1, 2007
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.9 years ago

Interventions

Medtronic Cardiac Ablation Systemprocedure

Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.

Class I or III Antiarrhythmic Medicationsdrug

Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.