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Completed

NCT Number: NCT01611701

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

State Research Institute of Circulation Pathology, Novosibirsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous failed first radiofrequency ablation procedure (only circumferential PV isolation without linear lesions) in patients referred for second catheter ablation of AF
  • > 3 months after first PVI

Exclusion criteria

  • Congestive heart failure
  • Ejection fraction <35%
  • Left atrial diameter >60 mm

Treatment and study plan

cryoballoon ablation

Procedure

In Cryo group, 28mm balloon was introduced into the PV ostium with the best possible occlusion of the PV. Every step was controlled by fluoroscopy. Cryoenergy was applied for maximal 6 minutes per application for 2 times, resulting in a circumferential ablation lesion. Before the right superior vein was treated, a quadripolar catheter was placed in the superior vena cava to continuously stimulate the right phrenic nerve during cryoapplication. The application was stopped immediately in the case of diminished diaphragm movements.

Radiofrequency ablation

Procedure

n RF group, reisolation of the PV was performed by identifying the breakthrough site. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s.

Primary outcomes

  1. Recurrence of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a second ablation procedure

    Time frame: 1 year

Secondary outcomes

  1. Percentage of complication after procedure between two groups

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

Cryoballoon Ablation of Pulmonary Veins After Failed Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 5, 2012
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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