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Calcium Handling and Epicardial Ablation

NCT04174885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-17

No results posted yet for this study

Summary

In this multi centre prospective study authors will evaluate atrial fibrillation (AF) recurrence at 360 days follow-up and calcium handling in patients treated by epicardial thoracoscopic ablation for persistent AF. Indeed, responders patients to epicardial ablation will experience sinus rhythm restoration after the treatment, and will be in sinus rhythm until follow-up end.

However, from October 2014 to June 2016, 27 consecutive patients with persistent AF will be identified and screened for participation in this prospective, multicenter trial at Catholic University of Sacred Heart, Campobasso, at University Study of Molise, Campobasso, at Vecchio Pellegrini Hospital, Naples and at University of Campania "Luigi Vanvitelli", Naples, Italy. All patients will receive an epicardial thoracoscopic pulmonary vein isolation. Before interventions, baseline laboratory studies, B type Natriuretic Peptide (BNP) and serum Sarcoplasmic Endoplasmic Reticulum Calcium ATPase (SERCA) will be evaluated. These markers will be re-evaluated at 12th month of follow-up.

Therefore, study hypothesis will be that successful epicardial ablation might reduce, in responders patients, the SERCA expression. Parallely, a lower serum expression of SERCA in patients with persistent AF might potentially identify a response to an epicardial ablative approach, and an innovative target to improve the response to an epicardial ablative treatment.

Conditions

  • Persistent Atrial Fibrillation

Interventions

PROCEDURE

epicardial ablation

In general anesthesia and left lung ventilation, authors will access the right thorax by three working ports. However, a rigid video thoracoscopic camera with a direct optics will be used. Pericardium will be widely opened anterior to a phrenic nerve and transverse and oblique sinuses were dissected. An insertion of the ablation catheter will be a tricky part of the surgery with the first MW catheter, while no special introducer will be provided. Later RF devices will be equipped with a special flexible introducers, lately also with a magnetic tip and the positioning of the catheter around PVs became much safer and easier. The correct position of catheter will be visualized by trans esophageal echocardiography before the ablation.

Sponsors & Collaborators

  • University of Campania Luigi Vanvitelli

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2018-01-01
Completion
2019-01-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04174885 on ClinicalTrials.gov