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Completed

NCT Number: NCT05045131

PeAF-BOX: Feasibility, Safety and Efficacy of PVI + Box Ablation in 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.

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Left atrial combined pulmonary vein isolation and posterior wall isolation

Procedure

Other names: Implantation of a subcutaneous cardiac monitor, Interventional reassessment and ablation (if needed) in the left atrium six months after the index procedure

Primary outcomes

  1. 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 %.

Secondary outcomes

  1. Feasibility of a first-procedure PVI + PWI strategy

    Time frame: The data are available immediately after the end of the index PVI + PWI procedure

    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.

  2. Temperature in the esophagus during radiofrequency ablation

    Time frame: The data are available immediately after the end of the index PVI + PWI procedure

    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.

  3. Durability of the PVI + PWI lesion set

    Time frame: The data are available immediately after the end of the six months reassessment procedure

    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 %.

  4. AF recurrence short term

    Time frame: The data are available 180 days after the index procedure

    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 %.

  5. AF burden short term

    Time frame: The data are available 180 days after the index procedure

    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 %.

  6. AF recurrence long term

    Time frame: The data are available 1080 days after the index procedure

    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 %.

  7. AF burden long term

    Time frame: The data are available 1080 days after the index procedure

    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 %

  8. Long term efficacy PVI + PWI

    Time frame: The data are available 1080 days after the index procedure

    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

  9. Effect on quality of life by PVI + PWI

    Time frame: Data are available from recruitment to end of follow-up at 3 years

    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]

Other outcomes

  1. Time to PVI

    Time frame: Data available immediately after index procedure

    Time from index procedure start until all (or all isolatable) pulmonary veins are electrically isolated at index procedure. Metric: Min.

  2. Time to PVI + PWI

    Time frame: Data available immediately after index procedure

    Time from index procedure start until all (or all isolatable) pulmonary veins and posterior walls are electrically isolated at index procedure. Metric: Min.

  3. Total procedure time

    Time frame: Data available immediately after index procedure

    Time from index procedure start until all catheters are removed from the veins. Metric: Min.

  4. Ablation time PVI

    Time frame: Data available immediately after index procedure

    Cumulated time of radiofrequency (RF) energy delivery required to achieve PVI during index procedure. Metric: min.

  5. Ablation time PVI + PWI

    Time frame: Data available immediately after index procedure

    Cumulated time of RF delivery required to achieve PVI + PWI during index procedure. Metric: min.

  6. Fluoroscopy time PVI

    Time frame: Data available immediately after index procedure

    Cumulated X-ray delivery time from start procedure until PVI achieved during index procedure. Metric: min.

  7. Fluoroscopy time PVI + PWI

    Time frame: Data available immediately after index procedure

    Cumulated X-ray delivery time from start procedure until all catheters removed from the veins in index procedure. Metric: min.

  8. Fluoroscopy dose PVI

    Time frame: Data available immediately after index procedure

    Cumulated X-ray dose to the participant from start procedure until PVI achieved during index procedure. Metric: Gy x cm^2

  9. Fluoroscopy dose PVI + PWI

    Time frame: Data available immediately after index procedure

    Cumulated X-ray dose to the participant from start procedure until all catheters removed from the veins in index procedure. Metric: Gy x cm^2

  10. Index procedure vascular access complications

    Time frame: Data available one month after completion of the index procedure

    The number of participants developing a complication related to vascular access in the right groin. Metric: n/N in %

  11. Index procedure tamponade/ effusions

    Time frame: Data available one day after completion of the index procedure

    The number of participants developing symptoms and signs of pericardial effusion during or after the procedure. Metric: n/N in %

  12. Left atrial volume

    Time frame: Data available after completion of the reassessment procedure

    The left atrial volume before the index procedure and before the reassessment procedure after 6 months. Estimated with 1) Contrast-CT scan of left atrium, 2) Echo - measured left atrial volume and 3) Left atrial volume estimated by electroanatomical mapping (Carto ®, Biosense Webster.Inc). Metric: ml.

  13. Left Ventricular Ejection Fraction (LVEF)

    Time frame: Data available 1 year after the index procedure

    The left ventricular systolic function estimated by LVEF before the index procedure, before the reassessment procedure after 6 months and at 1 year follow-up. Metric: %

Sponsors and collaborators

Lead sponsor

René Husted Worck

Other

Collaborators

  • Biosense Webster, Inc.

Registry information

Official study 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

Acronym: PeAF-BOX

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Sep 16, 2021
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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