Actively Recruiting

Age: 18Years - 80Years
All Genders
ID05777551

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

Led by Clinica Mediterranea · Updated on 2024-03-05

850

Participants Needed

9

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation (PVI) using high power short duration (HPSD) radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation (AF). This prospective, multi-center study aims to understand the relationship between clinical and procedural factors and the success and safety of this ablation method, with a follow-up period of 12 months to monitor AF recurrence. Patients with paroxysmal or persistent AF will undergo catheter ablation using approved mapping systems and catheters. The procedure involves sedation or anesthesia, vascular access through femoral or subclavian veins, and placement of diagnostic and ablation catheters in the left atrium. Ablation is performed with a QDot Micro catheter delivering radiofrequency energy in specific modes to isolate pulmonary veins. Effectiveness of the isolation is confirmed during the procedure, and any reconnections are addressed. Post-procedure, an ECG and optional echocardiogram are done to check for complications. During the 12-month follow-up, patients will have regular assessments at 3 months including history, physical exams, ECG, and 24-hour Holter monitoring to detect arrhythmia recurrence. Additional follow-ups between 6 and 12 months help confirm freedom from arrhythmia if no symptoms are reported. Researchers will measure outcomes such as arrhythmia recurrence rates, procedural times, vein reconnection, anesthesia impact, pain perception, and fluoroscopy duration to evaluate the procedure's overall safety and efficacy.

CONDITIONS

Brief Title

AF Ablation With High Power Short Duration RF

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with paroxysmal or persistent atrial fibrillation who have signed informed consent
  • Patients on active oral anticoagulation
Not Eligible

You will not qualify if you...

  • Previous ablation for atrial fibrillation
  • Left ventricular ejection fraction less than 35%
  • Women who may be pregnant
  • Contraindications to X-ray exposure
  • Congenital heart disease or cardiac surgery within 1 month

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Atrial Fibrillation Ablation Procedure

Duration - 1 day

Participants undergo atrial fibrillation ablation using a high power short duration radiofrequency catheter with sedation or anesthesia as preferred by the center.

1 procedure visit (in-person)

Post-procedural Assessment

Duration - 1 day

Participants receive a post-procedural ECG and optional echocardiogram to check for acute complications after ablation.

1 visit (in-person) immediately after procedure

Follow-up

Duration - Up to 12 months

Participants attend scheduled follow-up assessments including history, physical exam, ECG, and 24-hour Holter monitoring to check for arrhythmia recurrence.

Visits at 3 months and additional detailed follow-up at 6 to 12 months

Trial Site Locations

Total: 9 locations

1

Centre Cardiologique Du Nord

Paris, France

Actively Recruiting

2

Clinica Montevergine

Mercogliano, AV, Italy

Actively Recruiting

3

Maria cecilia Hospital

Cotignola, RA, Italy

Actively Recruiting

4

Ospedale di Conegliano

Conegliano, TV, Italy

Actively Recruiting

5

Università Politecnica delle Marche

Ancona, Italy

Actively Recruiting

6

Ospedale Civile di Asti

Asti, Italy

Actively Recruiting

7

Clinica Mediterranea

Naples, Italy, 80100

Actively Recruiting

8

Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.

Torino, Italy

Not Yet Recruiting

9

Royal Papworth Hospital

Cambridge, United Kingdom

Not Yet Recruiting

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Research Team

G

Giuseppe Stabile, MD

T

Teresa Strisciuglio, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry.

Giuseppe Stabile, Antoine Lepillier, Ermenegildo De Ruvo...

https://pubmed.ncbi.nlm.nih.gov/32369225

Standardized pulmonary vein isolation workflow to enclose veins with contiguous lesions: the multicentre VISTAX trial.

Mattias Duytschaever, Johan Vijgen, Tom De Potter...

https://pubmed.ncbi.nlm.nih.gov/32879974

Recovered pulmonary vein conduction as a dominant factor for recurrent atrial tachyarrhythmias after complete circular isolation of the pulmonary veins: lessons from double Lasso technique.

Feifan Ouyang, Matthias Antz, Sabine Ernst...

https://pubmed.ncbi.nlm.nih.gov/15623542

Prospective assessment of late conduction recurrence across radiofrequency lesions producing electrical disconnection at the pulmonary vein ostium in patients with atrial fibrillation.

Riccardo Cappato, Silvia Negroni, Domenico Pecora...

https://pubmed.ncbi.nlm.nih.gov/12963643

Early identification and treatment of PV re-connections: role of observation time and impact on clinical results of atrial fibrillation ablation.

Xin-hua Wang, Xu Liu, Yu-min Sun...

https://pubmed.ncbi.nlm.nih.gov/17522081

The role of adenosine following pulmonary vein isolation in patients undergoing catheter ablation for atrial fibrillation: a systematic review.

Alex J A McLellan, Saurabh Kumar, Catherine Smith...

https://pubmed.ncbi.nlm.nih.gov/23489944

High-power and short-duration ablation for pulmonary vein isolation: Safety, efficacy, and long-term durability.

Michael Barkagan, Fernando M Contreras-Valdes, Eran Leshem...

https://pubmed.ncbi.nlm.nih.gov/29846987

Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial.

Vivek Y Reddy, Massimo Grimaldi, Tom De Potter...

https://pubmed.ncbi.nlm.nih.gov/31320006