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Prevention of complications during atrial fibrillation ablation with the second-generation cryoballoon

Prevention of complications during atrial fibrillation ablation with the second-generation cryoballoon - Optimal ablation protocol second-generation cryoballoon

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41330
Enrollment
75
Registered
2014-05-21
Start date
2014-06-16
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atrial fibrillation cardiac arrhythmia

Interventions

The 3 groups undergo cryoballoon ablation with the new balloon, with a duration of cryoenergy application of 90, 120 or 150 seconds after PVI.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Any patient with atrial fibrillation scheduled for a first ablation procedure

Exclusion criteria

Exclusion criteria: Previous catheter or surgical ablation for atrial fibrillation, (longstanding) persistent atrial fibrillation, a diameter of one or more pulmonary veins > 28 mm and > 3 veins on the right side

Design outcomes

Primary

MeasureTime frame
The incidence of dormant conduction during the ablation procedure will be established en compared for three different ablation timeframes including 90, 120 or 150 seconds of additional cryoballoon ablation after acute PV isolation

Secondary

MeasureTime frame
1. The efficacy of AF ablation with the second-generation cryoballoon at 1 year follow-up will be investigated and also compared for the three different ablation timeframes 2. The incidence of (transient) phrenic nerve injury for the three groups will be registered and compared. The influence of the distance measured on CT scan between the RSPV ostium and the right phrenic nerve on the incidence will be assessed. 3. The incidence of esophageal lesions for the three groups will be established with gastroendoscopy and compared. The influence of minimal luminal esophageal temperature (LET) and cryoballoon temperature, duration of cryoenergy application and mean LET decrease on the formation of thermal lesions will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)