NCT03907982: ORBITA-AF

Investigation of Therapeutic Ablation Versus Cardioversion for AF

Completed NA Results posted Last updated 26 June 2025

What this trial tests

NA trial testing DC Cardioversion in Persistent Atrial Fibrillation in 20 participants. Completed in 26 April 2023.

Timeline

1 October 2021

Primary endpoint
26 April 2023

26 April 2023

Quick facts

Lead sponsor	Barts & The London NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	1 October 2021
Primary completion	26 April 2023
Estimated completion	26 April 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• DC Cardioversion
• Pulmonary vein isolation
• Implantable loop recorder

Conditions studied

• Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →
• Cardiac Arrhythmia — all drugs for Cardiac Arrhythmia →

Sponsor

Barts & The London NHS Trust — full company profile →

Who can join

Adults 18 to 80, any sex, with Persistent Atrial Fibrillation or Cardiac Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recurrence of Persistent AF (of AF Episode Lasting > 7 Days). Primary · Within 12 months following the procedure

Data on epsiodes of Atrial Fibrillation (rate, duration) will be provided by the loop recorder, and downloaded via a home monitoring system

Group	Value	95% CI
DCCV + PVI	3
DC Cardioversion (DCCV) + Placebo	6

Death Secondary · Within 12 months of study recruitment

Death of the patient

Group	Value	95% CI
DCCV + PVI	0
DC Cardioversion (DCCV) + Placebo	0

Rates of Subject Hospital Re-admission Secondary · Within 12 months following the procedure

Rates of admission of the subject back to hospital following the initial treatment for AF

Group	Value	95% CI
DCCV + PVI	0
DC Cardioversion (DCCV) + Placebo	1

Procedural Complications Secondary · At the time of the procedure

Assessment of rates of events that are considered procedural complications during the DCCV +/- Pulmonary Vein isolation (PVI) procedure

Group	Value	95% CI
DCCV + PVI	1
DC Cardioversion (DCCV) + Placebo	0

Bleeding Events Secondary · Within 7 days of the procedure

Rates of bleeding in subjects following the study DCCV +/- pulmonary vein isolation (PVI) procedures

Group	Value	95% CI
DCCV + PVI	1
DC Cardioversion (DCCV) + Placebo	0

Rates of Repeat Procedures Secondary · within 12 months following the procedure

Requirement for repeat procedures following the initial DCCV +/- pulmonary vein isolation (PVI) procedure for the study

Group	Value	95% CI
DCCV + PVI	4
DC Cardioversion (DCCV) + Placebo	7

Clinical Success of Procedure Secondary · Within 12 months following the procedure

Clinical procedural success as defined by 75% or greater reduction in the number of AF episodes as measured by the insertable cardiac monitoring system (LINQ) device.

Group	Value	95% CI
DCCV + PVI	7
DC Cardioversion (DCCV) + Placebo	6

Change in Quality of Life Measures (Using Short Form-12 Survey) Secondary · Between baseline and 12 months after procedure

Assessment of quality of life measures using Short Form Health Survey (SF12) questionnaire, which is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions are combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Scale range from 0 to 100, with higher scores indicating better quality of life.

Group	Value	95% CI
DCCV + PVI	12.21	± 11.37
DC Cardioversion (DCCV) + Placebo	14.15	± 2.73

Change in Quality of Life Measures (AF-PROMS) Secondary · between baseline and 12 months after procedure

Assessment of Patient Reported Outcome Measures (PROMS) specific for Atrial Fibrillation (AF) in a series of 28 questions to assess the impact of AF on the subject's quality of life. Atrial Fibrillation Severity Scale (AFSS) uses a scale ranging from 0 to 35, where a higher score indicates more severe symptoms.

Group	Value	95% CI
DCCV + PVI	-23	± 22
DC Cardioversion (DCCV) + Placebo	-2	± 10

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DCCV + PVI

Serious: 0/10 (0%)

Deaths: 0/10

DC Cardioversion (DCCV) + Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	DCCV + PVI	DC Cardioversion (DCCV) + …
incisionla site bleeding	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03907982 adverse events section.

Sponsor's own description

The main aim of the research is to investigate whether patients undergoing pulmonary vein isolation with cryoablation for atrial fibrillation (AF) will have lower rates of AF recurrence than those treated by DC cardioversion without an ablation procedure. The objectives of the Pilot Study are to validate the key study logistics with a view to optimising methods to be used in the main study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Year in Review: Atrial Fibrillation 2024.
   Ahmad A, Taranto LM, Karnik AA, Doshi R. · · 2025 · cited 1× · PMID 39897725 · DOI 10.19102/icrm.2025.16016