NCT05273645

Brief Summary

Pulmonary vein isolation emerged as an effective and safe strategy to treat atrial fibrillation patients. Atrio-oesophageal fistula (AOF) represents a rare but devastating complication of AF ablation procedure. This complication (0.016-0.07%) requires an international effort to allow for better understanding of the factors contributing to its occurrence and the best management strategies. A worldwide, retrospective, multicenter registry focusing on the incidence, diagnosis and management of this complication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

March 31, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

February 21, 2022

Last Update Submit

September 16, 2024

Conditions

Atrial FibrillationAtrio-Oesophageal FistulaPVICatheter Ablation

Outcome Measures

Primary Outcomes (1)

  • Incidence of AOF following percutaneous catheter ablation

    1\. Evaluating the Incidence of atrio-oesophageal fistula after percutaneous catheter ablation in patients with atrial fibrillation, as well as the more detailed analysis of the incidence of AOF after PVI with Cryo Balloon or RF Contact Force

    5 year

Secondary Outcomes (2)

  • Diagnosis and management of AOF

    5 year

  • Mortality rate

    5 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing PVI and developing an AOF

You may qualify if:

  • Atrio-oesophageal fistula after Ablation
  • Indication for AF ablation as per current guidelines
  • Performing the ablation at an ablation centre

You may not qualify if:

  • No Atrio-oesophageal fistula after Ablation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Rhythmologie

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (1)

  • Tilz RR, Schmidt V, Purerfellner H, Maury P, Chun KRJU, Martinek M, Sohns C, Schmidt B, Mandel F, Gandjbakhch E, Laredo M, Gunawardene MA, Willems S, Beiert T, Borlich M, Iden L, Futing A, Spittler R, Gaspar T, Richter S, Schade A, Kuniss M, Neumann T, Francke A, Wunderlich C, Shin DI, Meininghaus DG, Foresti M, Bonsels M, Reek D, Wiegand U, Bauer A, Metzner A, Eckardt L, Popescu SS, Krahnefeld O, Sticherling C, Kuhne M, Nguyen DQ, Roten L, Saguner AM, Linz D, van der Voort P, Mulder BA, Vijgen J, Almorad A, Guenancia C, Fauchier L, Boveda S, Greef Y, Da Costa A, Jais P, Derval N, Milhem A, Jesel L, Garcia R, Poty H, Khoueiry Z, Seitz J, Laborderie J, Mechulan A, Brigadeau F, Zhao A, Saludas Y, Piot O, Ahluwalia N, Martin C, Chen J, Antolic B, Leventopoulos G, Ozcan EE, Yorgun H, Cay S, Yalin K, Botros MS, Mahmoud AT, Jedrzejczyk-Patej E, Inaba O, Okumura K, Ejima K, Khakpour H, Boyle N, Catanzaro JN, Reddy V, Mohanty S, Natale A, Blessberger H, Yang B, Stevens I, Sommer P, Veltmann C, Steven D, Vogler J, Kuck KH, Merino JL, Keelani A, Heeger CH. A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study. Eur Heart J. 2023 Jul 14;44(27):2458-2469. doi: 10.1093/eurheartj/ehad250.

    PMID: 37062040DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roland R Tilz

    Universitaet Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Roland Richard Tilz

Study Record Dates

First Submitted

February 21, 2022

First Posted

March 10, 2022

Study Start

March 31, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)