Calcium Handling and Epicardial Ablation

NCT04174885 | Completed

• 1 other identifier: SecondUNI 18.11.2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation recurrence.

  Authors will evaluate the atrial fibrillation recurrence at 12 months of follow-up after epicardial ablation. Atrial fibrillation recurrence will be measured during clinical visits, and by the registration of 12 derivations electrogram (ECG), and ECG Holter.

  12 months

Study Arms (1)

AF epicardial ablation

OTHER

Patient with persistent AF will receive an epicardial ablation.

Procedure: epicardial ablation

Interventions

epicardial ablation PROCEDURE

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.

AF epicardial ablation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persistent AF, both genders, aged \>18 years, aged \< 75 years.

You may not qualify if:

• neoplastic diseases, inflammatory chronic diseases, acute and chronic heart failure.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (2)

Celestino Sardu

Naples, 80138, Italy

Location

Raffaele Marfella

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

IT (2)