Catheter Ablation in Symptomatic Atrial Fibrillation

• Sponsor: East Sussex Hospitals NHS Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04272762
• Collaborator: Eastbourne Cardiology Research Charity Fund (Other), Medtronic (Industry)
• Enrollment: 140
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 34.3
• Patients Per Site: 46.7
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Cryoablation; Procedure: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Catheter Ablation in Symptomatic Atrial Fibrillation: a Double Blind Randomised Controlled Trial
• Actual Study Start Date: Jan 23, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ablation pulmonary vein isolation	Procedure: Cryoablation; Pulmonary vein isolation with cryoablation
Placebo Comparator: Placebo placebo procedure	Procedure: Placebo; Placebo procedure

Outcome Measures

Primary Outcome Measures

1. Atrial fibrillation burden using continuous monitoring [6 months]

Secondary Outcome Measures

1. Time to symptomatic atrial tachyarrhythmia stratified by length of episode [6 months]

2. Time to asymptomatic atrial tachyarrhythmia stratified by length of episode [6 months]

3. Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode [6 months]

4. Change in AF specific quality of life score between each group (AF-PROMS) [Baseline and 6 months]

5. Change in health related quality of life in each group (36-Item Short Form Survey Instrument ) [Baseline and 6 months]

6. Comparison of medical treatment ( Antiarrhythmic drug use) [6 months]

7. Comparison of unscheduled use of health care services [6 months]

8. Number of procedure related complications / adverse events [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age greater than or equal to 18 years

• Symptomatic paroxysmal or persistent atrial fibrillation despite at least one antiarrhythmic drug (AAD Type I or III, β-blocker or AAD intolerance).

• Referred for catheter ablation

Exclusion Criteria:

• Long term persistent AF (continuous episode lasting more than 1)

• Prior left atrium catheter or surgical atrial fibrillation ablation

• Patients with other arrhythmias requiring ablative therapy

• Left atrium (LA) ≥5.5 cm

• Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrolment.

• Awaiting cardiac surgery or PCI

• Myocardial infarction within three months prior to enrolment.

• Stroke or transient ischemic attack (TIA) within three months prior to enrolment

• Unstable angina

• Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.

• Any condition contraindicating chronic anticoagulation

• Any untreated or uncontrolled hyperthyroidism or hypothyroidism

• Severe chronic kidney disease (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min)

• Patients with metallic prosthetic valves

• Pregnant or breastfeeding women

• Medical conditions limiting expected survival to <1 year

• History of claustrophobia or panic attacks

• Left ventricular ejection fraction (LVEF) less than 35%

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Essex Cardiothoracic Centre	Basildon		United Kingdom
2	Eastbourne District General Hospital	Eastbourne		United Kingdom
3	Conquest Hospital	St Leonards-on-Sea		United Kingdom

Sponsors and Collaborators

• East Sussex Hospitals NHS Trust
• Eastbourne Cardiology Research Charity Fund
• Medtronic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rick Veasey, Principal Investigator, East Sussex Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT04272762
• Other Study ID Numbers: 274347
• First Posted: Feb 17, 2020
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rick Veasey, Principal Investigator, East Sussex Hospitals NHS Trust: Atrial Fibrillation; Ablation; Cryoablation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Nov 9, 2021