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AF Ablation With High Power Short Duration RF

Sponsor: Clinica Mediterranea

NCT ID: NCT05777551

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 59 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at treating atrial fibrillation (AF), a condition where the heart beats irregularly, using a technique called catheter ablation. The ablation uses high power applied for a short time with radiofrequency (RF) energy to treat the areas of the heart causing the faulty signals. The study is sponsored by Clinica Mediterranea.

Who can take part

  • People with paroxysmal or persistent atrial fibrillation (AF), which means AF that comes and goes or lasts longer
  • People who have signed the informed consent form
  • People taking blood-thinning medicine by mouth (oral anticoagulation)

Who may not be able to

  • People who have had ablation for AF before
  • People whose heart pumping strength is below 35% (LVEF, left ventricular ejection fraction)
  • Women who could be pregnant
  • People who cannot have X-ray exposure for medical reasons
  • People born with a heart condition (congenital heart disease) or who have had heart surgery within the last month

What taking part involves

  • • Catheter ablation for atrial fibrillation (AF)
  • • Radiofrequency (RF) energy delivered at high power for a short duration

Time commitment: Not stated — ask the trial team about study visits, duration, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years to 80 Years
Who
All
Number of participants
850
Started
2023-01-01
Last checked
2024-03

Plain English Summary

What is this study?

  • • Testing a new treatment for atrial fibrillation
  • • Clinical study - 850 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 80 Years
  • • Diagnosed with atrial fibrillation

Where?

  • • Cambridge - Royal Papworth Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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

Atrial FibrillationCatheter Ablation

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 80 Years
  • Who can join: All genders

What the study is looking for

  • ✓Patients with paroxysmal/persistent AF who signed the agreement to take part
  • ✓Patients on active oral anticoagulation

Who cannot take part

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

Where Is This Study? (1 UK site)

Royal Papworth Hospital

Cambridge, United Kingdom

NOT_YET_RECRUITING
Hospital R&D contact (matched)

Vikki Hughes

papworth.randdenquiries@nhs.net01223 638000

How to Get in Touch

Giuseppe Stabile, MD

Sponsor contact

CONTACT

+393488960534 gmrstabile@tin.it

Teresa Strisciuglio, MD

Sponsor contact

CONTACT

+393293238130 teresa.strisciuglio@unina.it
Data sourced from ClinicalTrials.gov · Last verified: 2024-03