Calcium Handling and Epicardial Ablation

February 12, 2020 updated by: Celestino Sardu, University of Campania "Luigi Vanvitelli"

Calcium Handling and SERCA Protein Activity Modulation in Patients With Persistent Atrial Fibrillation (AF) Treated by Epicardial Thoracoscopic Ablation: the CAMAF Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Atrial fibrillation (AF) is most common arrhythmia in the worldwide population, and it is defined as paroxysmal, persistent and/or permanent. Patients with persistent AF might have higher rate of tromboembolic stroke, heart failure events and worse prognosis. Therefore, for patients with persistent AF the sinus rhythm restoration by catheter ablation might be a valid treatment to ameliorate clinical outcomes. On other hand, in patients with persistent AF the catheter ablation by percutaneous approach has a success rate about the 50% at 5 years of follow-up. Indeed, the endocardial ablation cannot determine deeper and extensive trans mural lesions in pulmonary veins and left atrium structure, and this might favor atrial fibrosis and remodeling with consequent persistence of arrhythmic substrate. In this setting, the epicardial AF ablation has been proposed to reach epicardial gaps of the complex arrhythmic atrial substrate, and this might favor sinus rhythm restoration with consequent reduction of the left atrial diameters and volume in patients with persistent AF. Notably, 40% of patients treated by epicardial ablatiion might show an AF recurrence at follow-up. This might be explained by multiple ionic, molecular and cellular alterations favoring AF persistence. In this setting, recently a great interest has been focused to study the calcium handling as cause of abnormal trigger activity and reentry in AF patients, that are both mechanisms implied in the genesis and perpetuation of persistent AF. Intriguingly, patients with persistent AF have an over activity of the Sarcoplasmic Endoplasmic Reticulum (SR) with increased calcium (Ca2+) release. However, in human atrial myocites the Ca2+ overload causes an increased prevalence of spontaneous events and delayed after depolarizations (DADs), (12). Therefore, the SERCA over activity increases the risk of Ca overload and this might be arrhythmogenic (13). Therefore, abnormal Ca2+ signaling and enhanced diastolic SR Ca2+ leak along with cellular DAD-mediated triggered activity might promote AF persistence, than favoring electrical and anatomical reentry. Conversely, the persistence of abnormal Ca2+ signaling and enhanced diastolic SR Ca2+ leak can activate ion channels and trigger Ca2+-dependent signaling pathways, thereby promoting the evolution of atrial remodeling and the progression of AF to more persistent forms. In this setting, authors might speculate that these AF-related alterations in Ca2+ handling and SERCA over activity might contribute to AF persistence after an epicardial ablation. Intriguingly, no data have been reported about the SERCA activity in patients with persistent AF before and after epicardial ablation. Moreover, authors study hypothesis is that a SERCA over expression might be linked to higher rate of failure to an epicardial ablation for patients with persistent AF. Thereafter, in this study authors will evaluate AF recurrences during 1 year of follow-up after epicardial ablation, correlating this clinical outcomes to SERCA protein modifications in patients with sinus rhythm restoration (responders group), vs. atrial fibrillating patients (non responders group) after an epicardial ablative approach.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
      • Naples, Italy, 80138
        • Raffaele Marfella
      • Naples, Italy, 80138
        • Celestino Sardu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: AF epicardial ablation
Patient with persistent AF will receive an epicardial ablation.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Atrial fibrillation recurrence.
Time Frame: 12 months
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Campania "Luigi Vanvitelli"

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SecondUNI 18.11.2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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