Atrial FibrillationPOTTERNCT05273645
PrOgnosis Following Esophageal FisTula FormaTion in Pts Undergoing CathetER Ablation for AF Study
An observational study of Atrial Fibrillation and Atrio-Oesophageal Fistula, run by University of Luebeck at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Atrio-Oesophageal Fistula, PVI
- How many people
- 138 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2022to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing PVI and developing an AOF
Who may be able to join
- Atrio-oesophageal fistula after Ablation
- Indication for AF ablation as per current guidelines
- Performing the ablation at an ablation centre
Who cannot join
- No Atrio-oesophageal fistula after Ablation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation
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.
Read the detailed description
Data about the incidence, optimal management and outcome of AOF is sparse. The largest national and international surveys report on less than 50 AOF. The latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed AOF after atrial fibrillation ablation procedure. In the meanwhile, the total number of AF ablation procedures increased significantly. Additionally, AF ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation.
The study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this AOF. More than 50 patients with AOF following percutaneous catheter ablation will be included in the register.
- Conditions
- Atrial Fibrillation, Atrio-Oesophageal Fistula, PVI, Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AOF following percutaneous catheter ablation
- 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
Measured: 5 year
Secondary outcomes (2)
Diagnosis and management of AOF
Evaluating the diagnosis and management of the AOF
Measured: 5 year
Mortality rate
Analysis of the mortality rate
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start31 Mar 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Richard Tilz, MD, University of Luebeck
- Investigators
- Roland R Tilz, Principal investigator, Universitaet Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273645
- Sponsor's protocol ID
- Potter AF Study
- Acronym
- POTTER
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37062040
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- World-wide Survey on the Incidence, Diagnosis and Prognosis of Atrio-oesophageal Fistula Following Percutaneous Catheter Ablation
- ClinicalTrials.gov ID
- NCT05273645
- Acronym / sponsor ID
- POTTER / Potter AF Study
- Conditions
- Atrial Fibrillation, Atrio-Oesophageal Fistula, PVI, Catheter Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data about the incidence, optimal management and outcome of AOF is sparse. The largest national and international surveys report on less than 50 AOF. The latest worldwide survey was conducted in 2015 and managed to include 31 patients who developed AOF after atrial fibrillation ablation procedure. In the meanwhile, the total number of AF ablation procedures increased significantly. Additionally, AF ablation technology changes significantly with e.g. increasing numbers of cryoballoon ablation and contact force guided radiofrequency ablation.
The study is designed as a worldwide, multi-centre, anonymised registry study to evaluate the incidence, optimal management and outcome of this AOF. More than 50 patients with AOF following percutaneous catheter ablation will be included in the register.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing PVI and developing an AOF
Key inclusion criteria (3 listed)
- Atrio-oesophageal fistula after Ablation
- Indication for AF ablation as per current guidelines
- Performing the ablation at an ablation centre
Key exclusion criteria (1 listed)
- No Atrio-oesophageal fistula after Ablation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of AOF following percutaneous catheter ablation
Time frame: 5 year
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
2 secondary outcomes
Diagnosis and management of AOF
Time frame: 5 year
Mortality rate
Time frame: 5 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 37062040Tilz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland R Tilz principal investigator
Universitaet Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrio-Oesophageal Fistula, run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of AOF following percutaneous catheter ablation (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.