Long-term Outcomes in Long Standing Persistent Atrial Fibrillation

NCT04280042 | Completed

• 1 other identifier: 271930
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation (AF) is a condition detected as an irregular heartbeat. It is the most common rhythm disturbance worldwide which can lead to significant symptoms and serious health problems (stroke and heart failure). The longer a person has AF, the more difficult it is to restore a normal heart rhythm. Those with continuous AF for longer than a year are described as having longstanding persistent AF (LSPAF). This is the most challenging type of AF to treat and medications are often not effective. Apart from medications patients with LSPAF may be offered a medical procedure to help improve their symptoms. It involves putting a flexible thin tube (catheter) into a blood vessel in the groin and up into the heart to destroy the tissue causing irregular heart beat. This procedure has modest success in improving symptoms in the long term. Recently, keyhole surgery has been used for these patients and evidence shows that it is better than the catheter procedure. However, we do not know how well people are doing beyond one year. Feedback from a patient focus group suggested that knowing the long-term results of these two procedures is important to help them make an informed choice when it comes to treatment. In this study we propose to continue monitoring patients from a randomised clinical trial (CASA AF RCT) who have already had one of the procedures. They have a small heartbeat monitor implanted under the skin with a battery life of around 3 years. We will be able to look at their heart rhythm data for the duration of this period and detect the return of the fibrillation if it happens.

Conditions

Long Standing Persistent Atrial Fibrillation

Keywords

atrial fibrillation; thoracoscopic surgical AF ablation; catheter ablation; implanted loop recorder

Outcome Measures

Primary Outcomes (1)

• Effectiveness of a single ablative procedure

  Freedom from continuous atrial arrhythmia (≥120 seconds in duration) recorded by implantable loop recorder or other clinically indicated rhythm recording device and absence of anti-arrhythmic drugs on concurrent medications form.

  over the duration of the followup period (24 months)

Secondary Outcomes (4)

• Reduction of burden of atrial fibrillation

  over the duration of the followup period (24 months)

• AF related quality of life

  at 24 and 36 months from the ablative treatment

• Quality of life assessment

  at 24 and 36 months from the ablative treatment

• Changes in concentration of serum biomarkers (pg/ml)

  from baseline to 36 months after the ablative procedure

Study Arms (2)

Thoracoscopic surgical ablation

Participants in CASA AF Trial who underwent thoracoscopic surgical ablation to treat their long standing persistent AF will be asked to continue downloading the data from their implanted loop recorder, attend two hospital appointments (at 24 and 36 months post ablation) to complete questionnaires, have an ECG, a blood test and report current medications they use.

Cather ablation

Participants in CASA AF Trial who underwent conventional catheter ablation to treat their long standing persistent AF will be asked to continue downloading the data from their implanted loop recorder, attend two hospital appointments (at 24 and 36 months post ablation) to complete questionnaires, have an ECG, a blood test and report current medications they use.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with long standing persistent atrial fibrillation who took part in the CASA AF clinical trial and underwent one of the intervetions: catheter ablation or surgical thoracoscopic ablation. These patients have agreed to keep their implanted loop recorders and continued to dowload their data.

You may qualify if:

• CASA-AF RCT participants who have undergone ablative procedure to treat their LSPAF, completed 12 months follow up and consented to keep their implanted loop recorders in situ with weekly data downloads.

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples to assess the values of a range of biomarkers.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom Wong

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: February 1, 2020
• Primary Completion: November 15, 2021
• Study Completion: February 1, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)