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NCT01611701 · ClinicalTrials.gov registry record · Phase 3

Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF

A Phase 3 study, sponsored by Meshalkin Research Institute of Pathology of Circulation.

Completed
Registry status
Phase 3
Development phase
80
Enrollment target

NCT01611701: Completed Phase 3 study, sponsored by Meshalkin Research Institute of Pathology of Circulation.

NCT01611701 is a Phase 3 study that has completed, run by Meshalkin Research Institute of Pathology of Circulation. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01611701, a Phase 3 study, has completed, sponsored by Meshalkin Research Institute of Pathology of Circulation.

COMPLETED
Registry status
Phase 3
Development phase
80 participants
Enrollment target

Study Summary

The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.

Interventions

  • PROCEDURE Radiofrequency ablation
  • PROCEDURE cryoballoon ablation

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2009-10
Est. Completion 2012-02
Phase Phase 3

What the finished NCT01611701 record still lists

NCT01611701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Radiofrequency ablation is the first listed.

NCT01611701 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01611701 about?

NCT01611701 is a clinical study titled "Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF". The aim of this prospective randomized double-blind study was to compare the efficacy and safety of cryoballoon ablation with the RF approach in the treatment of paroxysmal AF after failed first radiofrequency ablation.

What is the current status of trial NCT01611701?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2009-10. Estimated completion is 2012-02.

What interventions are being tested in trial NCT01611701?

The interventions under investigation include: Radiofrequency ablation (PROCEDURE), cryoballoon ablation (PROCEDURE).

Who is sponsoring clinical trial NCT01611701?

This trial is sponsored by Meshalkin Research Institute of Pathology of Circulation, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01611701's enrollment target sits among peer trials

80 1755th of 2000 higher than 233 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01611701, the US trial registry maintained by the National Library of Medicine. NCT01611701 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.