Mediastinal and esophageal alterations after pulmonary vein isolation

Mediastinal and esophageal alterations after pulmonary vein isolation - MADE-PVI (Mediastino-esophageal Alterations Detected Endosonographically after Pulmonary Vein Isolation)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016006

Enrollment

200

Registered

2018-12-17

Start date

2018-01-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I48.0 I48.1 I48.2

Interventions

Group 1: Esophagogastroscopy and endosonography before and after PVI (Pulmonary Vein Isolation)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Full legal capacity of the patient, clinical indication for pulmonary vein isolation, voluntary participation and signed written informed consent

Exclusion criteria

Exclusion criteria: esophageal pathologies, prior pulmonary vein Isolation, contraindication for esophagogastroscopy / endosonography, pregnancy or breast-feeding, refusal of participation

Design outcomes

Primary

Measure	Time frame
Esophageal, paraesophageal and mediastinal alterations and complications after pulmonary vein isolation	—

Secondary

Measure	Time frame
Atrio-esophago Fistula, esophageal ulceration, mediastinal fibrosis, mediastinal edema, hospitalisation within 30 days after PVI, 30-days mortality, cardial complications, post-procedure femural access site complications	—

Countries

Germany

Contacts

Public ContactLars Eckardt

Universitätsklinikum Münster; Klinik für Kardiologie II - Rhythmologie

Lars.Eckardt@ukmuenster.de0049 (0) 251 83 47637 oder 47851

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 23, 2026