Cryoballoon and Associated Esophageal Effects
Cuvinte cheie
Abstract
Descriere
When treating atrial fibrillation and targeting various areas in the left atrium, electrophysiologists have the choice to perform ablation with RF energy or cryoenergy. Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the investigators would very much like to understand how to completely prevent these occurrences. Cryoenergy has more recently been introduced as an energy source used in the PVI procedure; therefore, for this energy source, rates of esophageal ulceration are not yet well-defined. Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon procedures.
Datele
| Ultima verificare: | 04/30/2018 |
| Primul depus: | 03/24/2016 |
| Inscriere estimată trimisă: | 05/19/2019 |
| Prima postare: | 05/22/2019 |
| Ultima actualizare trimisă: | 05/19/2019 |
| Ultima actualizare postată: | 05/22/2019 |
| Data actuală de începere a studiului: | 11/24/2015 |
| Data estimată de finalizare primară: | 05/01/2018 |
| Data estimată de finalizare a studiului: | 05/01/2018 |
Stare sau boală
Intervenție / tratament
Procedure: Esophageal Effects
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Other: Esophageal Effects To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation. Esophageal temperature probe is used during cryoablation to measure temperatures and then a 4-7 days post procedure esophagoscopy is performed to evaluate the physical effects on the esophagus. | Procedure: Esophageal Effects Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe. |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 18 Years La 18 Years |
| Sexe eligibile pentru studiu | All |
| Acceptă voluntari sănătoși | da |
| Criterii | Inclusion Criteria: 1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned cryoballoon pulmonary vein isolation 2. Age >18 years 3. Planned AF cryoablation procedure Exclusion Criteria: 1. LA diameter >55mm 2. Severe LVH (LV wall ≥ 15mm) 3. LA thrombus 4. Decompensated heart failure 5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins 6. History of previous pulmonary vein isolation 7. Inability to place esophageal temperature probe or TEE probe 8. Previously documented phrenic nerve injury 9. Known esophageal pathology (complete GI history worksheet) |
Rezultat
Măsuri de rezultate primare
1. Rate of temperature decline [Up to 3 years]
2. Associate the development of symptoms [Up to 3 years]
Măsuri de rezultate secundare
1. Phrenic nerve injury [Up to 3 years]
2. Post procedure symptoms [Up to 3 years]
