Atrial FibrillationPeAF-BOXNCT05045131
PeAF-BOX: Feasibility, Safety and Efficacy of PVI + Box Ablation in Persistent Atrial Fibrillation
A study testing Left atrial combined pulmonary vein isolation and posterior wall isolation in people with Atrial Fibrillation, run by René Husted Worck.
Trial summary
Title: PeAF-Box. Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall (PWI) added to Pulmonary Vein Isolation (PVI) as First-Line Strategy in Treatment of Persistent Atrial Fibrillation (PeAF) Design: A prospective, observational, single center, unblinded, clinical study with 3 years of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Left atrial combined pulmonary vein isolation and posterior wall isolation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2016to 14 Nov 2020
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic persistent atrial fibrillation (EHRA symptom class II or above)
- Prior failed treatment with at last one antiarrhythmic drug (Class I-IV)
- Clinical indication for ablation
- Persistent atrial fibrillation meeting both the following requirements:
- One or more episodes of atrial fibrillation lasting longer than seven days, regardless of mode of termination
- Estimated cumulated time in PeAF more than 3 months and less than 36 months
Who cannot join
- Contraindication for ablation
- Predominantly PAF phenotype
- Valvular Heart disease
- Previous ablation in heart
- Previous heart surgery (including valve surgery and coronary artery bypass grafting - CABG)
- Documented atrial flutter or other arrhythmia requiring ablation besides PVI
Show all 22Show fewer
- Greatly enlarged left atrium on Trans thoracic Echocardiography (TTE ; diameter > 52 mm in males and diameter > 47 mm in females)
- LVEF < 35%
- Implanted pacemaker or defibrillator
- Presence of intramural thombus, tumor or other abnormality precluding catheter introduction
- Pregnancy
- Intolerance to Amiodarone
- Unstable angina pectoris
- Myocardial infarction within 3 months of inclusion
- History of blood clotting or bleeding anomalies
- Malignant disease (non metastatic skin cancer excluded)
- Severe obesity (Mody mass index > 35 kg/m^2)
- Active systemic infection
- Renal insufficiency (serum creatinine > 150 mmoles/liter)
- Psychiatric illness
- Substance abuse
- Participation in other clinical trials
About this study
Official title: PeAF-Box. A Study to Investigate the Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall Adjunctive to Pulmonary Vein Isolation as First-line Therapeutical Strategy in Treatment of Persistent Atrial Fibrillation
Title: PeAF-Box. Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall (PWI) added to Pulmonary Vein Isolation (PVI) as First-Line Strategy in Treatment of Persistent Atrial Fibrillation (PeAF)
Design: A prospective, observational, single center, unblinded, clinical study with 3 years of follow-up and two interventional procedures: An index ablation procedure and a reassessment/ reablation procedure after 6 months.
Read more
Background: In patients with PeAF the effect of first-line ablation with pulmonary vein isolation (PVI) is smaller than in patients with paroxysmal atrial fibrillation (PAF), where PVI alone is effective in reducing symptoms and increasing quality of life. Adding PWI to PVI is increasingly used despite concerns about safety and efficacy.
Objectives: (1) To use PVI + PWI as first-line ablation-strategy in participants with PeAF and to assess the feasibility of obtaining that goal. (2) To assess the safety of applying this lesion set - in terms of heat-induced injury to the esophagus - using esophagoscopy. 3) To asses arrhythmia burden using continuous monitoring for 3 years after ablation. (4) To assess the durability of the PVI + PWI lesion set by a relook/ reablation procedure after 6 months. (5) To follow the effect of PVI + PWI on participants' quality of life over three years.
Study site: Dept of Cardiology - Electrophysiology Laboratory, Gentofte Hospital, University of Copenhagen.
Study population: 24 patients referred for ablation of PeAF are asked for informed consent for these elements that surpass standard treatment in PeAF: (1) Taking amiodarone for 3 weeks prior to the index procedure to 3 weeks after the procedure, (2) Additional ablation with PWI compared to standard first-line therapy with PVI only. (3) Implantation of an implantable cardiac monitor (ICM), (4) Post-procedure esophagoscopy, (5) Regular clinic visits for 3 years post procedure, (6) Undergoing an interventional relook/ reablation procedure 6 months after the index procedure.
Anticoagulation drugs during the procedure and follow up: To prevent thromboses participants are prescribed periprocedural oral anticoagulant treatment to be continued for shorter or longer/lifelong periods according to the participants' risk of thrombosis (the CHA2DS2-VASC score).
Anti-arrhythmic drugs (AADs): Except from periprocedural amiodarone treatment, no AADs are allowed during the follow-up apart from occurrence of otherwise untreatable arrhythmias.
- Conditions
- Atrial Fibrillation
- Being tested
- Left atrial combined pulmonary vein isolation and posterior wall isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left atrial combined pulmonary vein isolation and posterior wall isolationProcedure or surgery
Also called Implantation of a subcutaneous cardiac monitor, Interventional reassessment and ablation (if needed) in the left atrium six months after the index procedure
| Study group | Role | What they receive |
|---|---|---|
| PVI+PWI, 6 months reassessment procedure, 3 year continued rhythm monitoring | Experimental | Single arm experimental, observational study: All participants receive a single-procedure combined PVI + posterior wall isolation (PVI+PWI), loop recorder implantation, esophagoscopy, a mandated interventional reassessment /reablation procedure at six months and continuous rhythm monitoring for three years Receives: Procedure: Left atrial combined pulmonary vein isolation and posterior wall isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of single procedure PVI + PWI
Defined as the incidence of inflammation or other injury to the esophagus detected under mandated esophagoscopy on the day after PVI + PWI with radiofrequency ablation. The endoscopy is carried out, assessed and electronically stored by a board-certified gastroenterologist. Metric: n/N in %.
Measured: Esophagoscopy is carried out at least 20 hours and less than 48 hours after the index ablation procedure
Secondary outcomes (9)
Feasibility of a first-procedure PVI + PWI strategy
Defined as the ability to achieve complete bidirectional isolation of the left atrial posterior wall as well as all pulmonary veins at a reasonable cost in terms of procedure-, ablation and fluoroscopy times and total patient radiation exposure. Electrical isolation is assessed by visual inspection of electrocardiograms and classical electrophysiological pacing- and sensing maneuvers in the left atrium.
Measured: The data are available immediately after the end of the index PVI + PWI procedure
Temperature in the esophagus during radiofrequency ablation
Defined as the maximum temperature measured in degrees Celsius with one decimal and evaluated for each individual ablation during point-by-point ablations to achieve PVI + PWI. Metric: Degrees Celsius.
Measured: The data are available immediately after the end of the index PVI + PWI procedure
Durability of the PVI + PWI lesion set
Defined as the proportions of pulmonary veins and left atrial posterior walls remaining durably isolated when controlled at the six months reassessment procedure. Electrical isolation is assessed by visual inspection of electrocardiograms and classical electrophysiological pacing- and sensing maneuvers in the left atrium. Metric: n/N in %.
Measured: The data are available immediately after the end of the six months reassessment procedure
AF recurrence short term
Defined as the proportion of participants with recurring atrial fibrillation of at least 2 minutes duration and the time to the first recurrence detected during continuous rhythm monitoring by the implanted loop recorder in the time frame of 90 days from end blanking period to 180 days post index procedure (time of scheduled reassessment procedure). Metric: n/N in %.
Measured: The data are available 180 days after the index procedure
AF burden short term
Defined as cumulated time in atrial fibrillation (minutes) divided by the total number of minutes in the 90 days observation period between end blanking period and time of scheduled reassessment procedure. Metric: min/min in %.
Measured: The data are available 180 days after the index procedure
AF recurrence long term
Defined as the proportion of participants with recurring atrial fibrillation of at least 2 minutes duration and the time to the first recurrence detected during continuous rhythm monitoring by the implanted loop recorder in the time frame between the reassessment / reablation procedure at 180 days and full three years (1080 days) observation time after the index procedure. Metric n/N in %.
Measured: The data are available 1080 days after the index procedure
AF burden long term
Defined as cumulated time in atrial fibrillation (minutes) divided by the total number of minutes in the 900 days observation period between the 6 months reassessment/ reablation procedure and full three years observation time (1080 days). Moreover, AF burden is calculated every 3 to 6 months during the entire follow - up period. Metric: min./min. in %
Measured: The data are available 1080 days after the index procedure
Long term efficacy PVI + PWI
Defined as incidence of anti arrhythmic drug therapy and repeat ablations between the the reassessment procedure at 180 days and end follow-up at 1080 days. Metric: number of patients and specification of drug
Measured: The data are available 1080 days after the index procedure
Effect on quality of life by PVI + PWI
Defined as self reported scores obtained by repeat answering of the Atrial Fibrillation Effect on Quality of Life (AFEQT) score system. The questionnaire is administered every three to six months to coincide with clinic visits and calculation of AF burden. Metric: range [0-100]
Measured: Data are available from recruitment to end of follow-up at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start17 Mar 2016
- Primary completion15 Nov 2017
- Study completion14 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The PeAF - Box study is observational and investigates single procedure PVI+PWI. Adding PWI to PVI substantially increases the amount of ablation close to the esophagus raising concerns of the risk of esophageal thermal injury. Accordingly, the study includes a formal analysis of the safety of PVI+PWI in terms of risk of esophageal thermal injury. The study includes 24 participants based on power calculations showing that at least 23 participants were required to illustrate a non-inferior risk of inducing esophageal thermal injury by PVI+PWI compared to relevant recently published data.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- René Husted Worck
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, René Husted Worck, University Hospital, Gentofte, Copenhagen
- Investigators
- René H Worck, MD, Principal investigator, Herlev-Gentofte Hospital, UCPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045131
- Sponsor's protocol ID
- PeAF-BOX study
- Acronym
- PeAF-BOX
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Worck R, Sorensen SK, Johannessen A, Ruwald MH, Hansen ML, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation. Long-term outcomes of a repeat procedure strategy. J Interv Card Electrophysiol. 2023 Jun;66(4):971-979. doi: 10.1007/s10840-022-01402-x. Epub 2022 Nov 3.
PubMed 36327059Worck R, Sorensen SK, Johannessen A, Ruwald M, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy. J Cardiovasc Electrophysiol. 2022 Aug;33(8):1667-1674. doi: 10.1111/jce.15556. Epub 2022 May 31.
PubMed 35598313
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeAF-Box. A Study to Investigate the Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall Adjunctive to Pulmonary Vein Isolation as First-line Therapeutical Strategy in Treatment of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05045131
- Acronym / sponsor ID
- PeAF-BOX / PeAF-BOX study
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- René Husted WorckUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 17 Mar 2016 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 16 Sep 2021 (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.
Title: PeAF-Box. Feasibility, Safety and Efficacy of Isolating the Left Atrial Posterior Wall (PWI) added to Pulmonary Vein Isolation (PVI) as First-Line Strategy in Treatment of Persistent Atrial Fibrillation (PeAF)
Design: A prospective, observational, single center, unblinded, clinical study with 3 years of follow-up and two interventional procedures: An index ablation procedure and a reassessment/ reablation procedure after 6 months.
Background: In patients with PeAF the effect of first-line ablation with pulmonary vein isolation (PVI) is smaller than in patients with paroxysmal atrial fibrillation (PAF), where PVI alone is effective in reducing symptoms and increasing quality of life. Adding PWI to PVI is increasingly used despite concerns about safety and efficacy.
Objectives: (1) To use PVI + PWI as first-line ablation-strategy in participants with PeAF and to assess the feasibility of obtaining that goal. (2) To assess the safety of applying this lesion set - in terms of heat-induced injury to the esophagus - using esophagoscopy. 3) To asses arrhythmia burden using continuous monitoring for 3 years after ablation. (4) To assess the durability of the PVI + PWI lesion set by a relook/ reablation procedure after 6 months. (5) To follow the effect of PVI + PWI on participants' quality of life over three years.
Study site: Dept of Cardiology - Electrophysiology Laboratory, Gentofte Hospital, University of Copenhagen.
Study population: 24 patients referred for ablation of PeAF are asked for informed consent for these elements that surpass standard treatment in PeAF: (1) Taking amiodarone for 3 weeks prior to the index procedure to 3 weeks after the procedure, (2) Additional ablation with PWI compared to standard first-line therapy with PVI only. (3) Implantation of an implantable cardiac monitor (ICM), (4) Post-procedure esophagoscopy, (5) Regular clinic visits for 3 years post procedure, (6) Undergoing an interventional relook/ reablation procedure 6 months after the index procedure.
Anticoagulation drugs during the procedure and follow up: To prevent thromboses participants are prescribed periprocedural oral anticoagulant treatment to be continued for shorter or longer/lifelong periods according to the participants' risk of thrombosis (the CHA2DS2-VASC score).
Anti-arrhythmic drugs (AADs): Except from periprocedural amiodarone treatment, no AADs are allowed during the follow-up apart from occurrence of otherwise untreatable arrhythmias.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The PeAF - Box study is observational and investigates single procedure PVI+PWI. Adding PWI to PVI substantially increases the amount of ablation close to the esophagus raising concerns of the risk of esophageal thermal injury. Accordingly, the study includes a formal analysis of the safety of PVI+PWI in terms of risk of esophageal thermal injury. The study includes 24 participants based on power calculations showing that at least 23 participants were required to illustrate a non-inferior risk of inducing esophageal thermal injury by PVI+PWI compared to relevant recently published data.
| Arm | Type | Receives |
|---|---|---|
| PVI+PWI, 6 months reassessment procedure, 3 year continued rhythm monitoring | Experimental | Procedure: Left atrial combined pulmonary vein isolation and posterior wall isolationSingle arm experimental, observational study: All participants receive a single-procedure combined PVI + posterior wall isolation (PVI+PWI), loop recorder implantation, esophagoscopy, a mandated interventional reassessment /reablation procedure at six months and continuous rhythm monitoring for three years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with symptomatic persistent atrial fibrillation (EHRA symptom class II or above)
- Prior failed treatment with at last one antiarrhythmic drug (Class I-IV)
- Clinical indication for ablation
- Persistent atrial fibrillation meeting both the following requirements:
Key exclusion criteria (22 listed)
- Contraindication for ablation
- Predominantly PAF phenotype
- Valvular Heart disease
- Previous ablation in heart
- Previous heart surgery (including valve surgery and coronary artery bypass grafting - CABG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left atrial combined pulmonary vein isolation and posterior wall isolationAlso: Implantation of a subcutaneous cardiac monitor, Interventional reassessment and ablation (if needed) in the left atrium six months after the index procedure | Procedure or surgery | PVI+PWI, 6 months reassessment procedure, 3 year continued rhythm monitoring |
Primary outcome
The safety of single procedure PVI + PWI
Time frame: Esophagoscopy is carried out at least 20 hours and less than 48 hours after the index ablation procedure
Defined as the incidence of inflammation or other injury to the esophagus detected under mandated esophagoscopy on the day after PVI + PWI with radiofrequency ablation. The endoscopy is carried out, assessed and electronically stored by a board-certified gastroenterologist. Metric: n/N in %.
9 secondary outcomes
Feasibility of a first-procedure PVI + PWI strategy
Time frame: The data are available immediately after the end of the index PVI + PWI procedure
Temperature in the esophagus during radiofrequency ablation
Time frame: The data are available immediately after the end of the index PVI + PWI procedure
Durability of the PVI + PWI lesion set
Time frame: The data are available immediately after the end of the six months reassessment procedure
AF recurrence short term
Time frame: The data are available 180 days after the index procedure
AF burden short term
Time frame: The data are available 180 days after the index procedure
AF recurrence long term
Time frame: The data are available 1080 days after the index procedure
AF burden long term
Time frame: The data are available 1080 days after the index procedure
Long term efficacy PVI + PWI
Time frame: The data are available 1080 days after the index procedure
Effect on quality of life by PVI + PWI
Time frame: Data are available from recruitment to end of follow-up at 3 years
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 16 Sep 2021.
- Derived from this study: PubMed 36327059Worck R, Sorensen SK, Johannessen A, Ruwald MH, Hansen ML, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation. Long-term outcomes of a repeat procedure strategy. J Interv Card Electrophysiol. 2023 Jun;66(4):971-979. doi: 10.1007/s10840-022-01402-x. Epub 2022 Nov 3.
- Derived from this study: PubMed 35598313Worck R, Sorensen SK, Johannessen A, Ruwald M, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy. J Cardiovasc Electrophysiol. 2022 Aug;33(8):1667-1674. doi: 10.1111/jce.15556. Epub 2022 May 31.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
René H Worck, MD principal investigator
Herlev-Gentofte Hospital, UCPH
Questions about this trial
What is this clinical trial studying?
A study testing Left atrial combined pulmonary vein isolation and posterior wall isolation in people with Atrial Fibrillation, run by René Husted Worck.
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 6 inclusion and 22 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The safety of single procedure PVI + PWI (time frame: Esophagoscopy is carried out at least 20 hours and less than 48 hours after the index ablation procedure). 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 NCT05045131, which also lists 2 linked publications.
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 16 Sep 2021.