AF Ablation With High Power Short Duration RF (AIR HPSD)

March 2, 2024 updated by: Clinica Mediterranea

Atrial Fibrillation Ablation by Means of Very High Power Short Duration (AIR HPSD Registry)

This is a prospective, multi-center, research study designed to evaluate the safety and efficacy of pulmonary vein (PV) isolation with high power short duration radiofrequency energy in patients with paroxysmal/persistent atrial fibrillation (AF).

Subjects with paroxysmal/persistent AF will undergo catheter ablation using commercially approved devices (mapping system and catheters).

Patients will be followed up for 12 months to measure the recurrence of AF and its predictors. The primary endpoint will be to investigate the association between clinical and procedural characteristics and the efficacy and the safety of PVI performed with HPSD.

At least 850 consecutive will be enrolled to have an adequate statistical power for the analysis of the primary endpoint. We assume that the freedom form AF recurrence at 12 months will be 80%. Expected R^2 (Cox-Snell) 0.1. Candidate variables to be included in the model:10. Shrinkage level: 0.9. Based on these assumption the minimum number of patients is 850 with 170 events and EPP 17.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients will be screened in ambulatory and scheduled for AF ablation according to current guidelines. Ablation will be usually performed under effective oral anticoagulation. Anticoagulation could be withdrawn before admission, so as antiarrhythmic drugs will be removed before scheduled procedure. Patients in AF or with a CHA2DS2-VASc score ≥ 1 will undergo transesophageal echocardiography within 48 hours prior to the ablation. For all other patients transesophageal echocardiography is optional. Cardiac MRI or Cardiac CT scan could be executed as a reference for volume estimations obtained with the mapping system.

Ablation will be carried out under mild or deep sedation, or general anesthesia according to center preference. At least 2 femoral vein access will be obtained and in some patients 1 subclavian vein. One diagnostic catheter will be positioned in the coronary sinus. One or two transseptal accesses to the left atrium will be achieved using a standard approach. Then, the mapping catheter (LASSO, Penta-ray, Octa-ray catheter) and the ablation catheter (QDot Micro catheter) will be placed in the left atrium. Heparin will be administered before the transseptal punctures to maintain an activated clotting time ≥ 300 seconds for the duration of the procedure. Left atrium mapping will be performed in sinus rhythm. Patients with atrial fibrillation at the beginning of the index procedure will undergo electrical cardioversion. After left atrium reconstruction the effective PV-left atrium electrical connection will be checked with the mapping catheter. In all patients a wide antrum circumferential ablation aimed at PV isolation will be performed using the QDot Micro catheter in QMode+ mode (90 w for 4 sec) for the whole ablation or in an hybrid mode (QMode + for posterior wall and QMode guided by AI in the anterior wall), according to the operator preference. The maximum interlesion distance will be <6 mm (16,17). According to operator preference it will be performed an ablation line encircling each PV or two ablation lines encircling the right and the left PVs. At the end of the ablation effective PV isolation (entry and exit block), will be checked with mapping catheter. After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol. If the vein reconnects to the atrium, the ablation will be directed to the gaps identified by the mapping catheter.

All patients will undergo a post-procedural ECG and, optional, an echocardiogram to exclude pericardial effusion or other acute complications.

After ablation, patients will undertake regular follow-up assessments (scheduled at 3 months) including a detailed history, physical examination, 12-lead standard electrocardiography, and 24-h Holter monitoring. Patients who will not report any symptoms related to the previous arrhythmia during a supplementary detailed follow up (6-12 months subsequent to catheter ablation) will be considered free of arrhythmia recurrence

Study Type

Observational

Enrollment (Estimated)

850

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • Centre Cardiologique du Nord
        • Contact:
          • Antoine Lepillier
  • Italy
      • Ancona, Italy
        • Recruiting
        • Università Politecnica delle Marche
        • Contact:
          • Michela Casella
        • Principal Investigator:
          • Antonio Dello Russo
      • Asti, Italy
        • Recruiting
        • Ospedale Civile di Asti
        • Contact:
          • Marco Scaglione
      • Napoli, Italy, 80100
        • Recruiting
        • Clinica Mediterranea
        • Contact:
          • Giuseppe Stabile
      • Torino, Italy
        • Not yet recruiting
        • Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.
        • Contact:
          • Matteo Anselmino
    • AV
      • Mercogliano, AV, Italy
        • Recruiting
        • Clinica Montevergine
        • Contact:
          • Francesco Solimene
    • RA
      • Cotignola, RA, Italy
        • Recruiting
        • Maria Cecilia Hospital
        • Contact:
          • Saverio Iacopino
    • TV
      • Conegliano, TV, Italy
        • Recruiting
        • Ospedale di Conegliano
        • Contact:
          • Roberto Mantovan, MD
  • United Kingdom
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Royal Papworth Hospital
        • Contact:
          • Claire Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with paroxysmal/persistent AF with indication to catheter ablation according to current guidelines

Description

Inclusion Criteria:

  • Patients with paroxysmal/persistent AF who signed the informed consent
  • Patients on active oral anticoagulation

Exclusion Criteria:

  • Previous ablation for AF
  • Patients with LVEF<35%
  • Women potentially pregnant
  • Contraindications to X-ray exposure
  • Congenital heart disease or cardiac surgery within 1 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between clinical and procedural characteristics and the percentage of arrhythmia recurrence rate after PV isolation performed with HPSD.
Time Frame: 12 months after ablation
to assess the efficacy of the procedure in terms of atrial arrhythmia recurrence-free rate (binary outcome), with a number of candidate predictors equal to 10
12 months after ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of acute pulmonary vein reconnection reconnection
Time Frame: 20 minutes after ablation
After PV isolation will be achieved, the reconnection of the same vein will be evaluated after a 20 minute period from the initial isolation or after adenosine infusion or isoproterenol.
20 minutes after ablation
Procedural time
Time Frame: during the procedure
The Investigators will calculate the overall procedural time (min)
during the procedure
Percentage of patients with atrial arrhythmias recurrence during the blanking period
Time Frame: 3 months after ablation
Number of patients with an atrial arrhythmia (atrial fibrillation, atrial tachycardia, atrial flutter) episode lasting at least 30 sec during the 3 month blanking period after the index ablation
3 months after ablation
Impact of anaesthesia type
Time Frame: during the procedure
The Investigators will evaluate the type of anesthesia: (mild sedation, deep sedation, general anesthesia), the anesthetic drugs used and their dose in mg
during the procedure
Evaluation of pain perception during ablation
Time Frame: during the procedure
The Investigators will assess the pain during the ablation with a 0-10 pain scale (0 no pain, 1-3 mild, 4-6 moderate, 7-9 severe, 10 very severe).
during the procedure
Fluoroscopy time
Time Frame: during the procedure
The Investigators will calculate the overall fluoroscopy time (sec)
during the procedure
Radiofrequency time
Time Frame: during the procedure
The Investigators will calculate the overall radiofrequency time (sec)
during the procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 30 days and 12 months after ablation
Number of participants with treatment-related adverse events, acute and at 30-day and 12-month as assessed by CTCAE v4.0
30 days and 12 months after ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Mediterranea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIR HPSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

starting 6 months after publication on primary end point

IPD Sharing Access Criteria

The data will be shared on reasonable request to the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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