Pulmonary Vein Isolation (PVI) versus PVI plus Selective Ablation of Low VoltagE Areas for Persistent Atrial Fibrillation (SOLVE-AF) – A Randomized Multi-Center Trial

Pulmonary Vein Isolation (PVI) versus PVI plus Selective Ablation of Low VoltagE Areas for Persistent Atrial Fibrillation (SOLVE-AF) – A Randomized Multi-Center Trial - SOLVE-AF

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010429

Enrollment

450

Registered

2017-08-10

Start date

2017-08-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I48.1

Interventions

Group 1: Patients with atrial low voltage areas (randomized): Pulmonary vein isolation and selective ablation of atrial low voltage areas Group 2: Patients with atrial low voltage areas (randomized):

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age =18 years and 7days and <12 months longest AF duration) 3. Written informed consent obtained according to international guidelines and local laws 4. Ability to understand the nature of the trial and the trial related procedures and to comply with them

Exclusion criteria

Exclusion criteria: 1. Previous ablation for AF 2. Contra-indications for AF catheter ablation therapy (thrombus in left atrium (LA), at TEE high risk for bleeding under anticoagulant therapy, short life expectancy) 3. Patients with paroxysmal AF (12 months) 5. LA diameter >55 mm 6. Hyperthyroidism 7. Heart failure, NYHA 3 and 4 8. Valvular AF (Mitral or aortic valvulopathy >Grade 2/3) 9. Other major disabling disease 10. Current pregnancy

Design outcomes

Primary

Measure	Time frame
Single-procedural freedom of atrial fibrillation (AF) and atrial tachycardia/ flutter (AT) without antiarrhythmic drug treatment within 12 months after the first ablation procedure.	—

Secondary

Measure	Time frame
Efficacy: • Single-procedural freedom of atrial fibrillation (AF) without antiarrhythmic drug treatment after the first ablation procedure (12 months after the ablation procedure) • Multi-procedural freedom of atrial fibrillation (AF) and atrial tachycardia/ flutter (AT) without antiarrhythmic drug treatment 12 months after the last ablation procedure. Note: Re-ablation procedures after the blanking period of 1st ablation procedure are allowed in case of arrhythmia recurrence using the same ablation strategy to which the patient was randomized. • Multi-procedural freedom of atrial fibrillation (AF) without antiarrhythmic drug treatment after the last ablation procedure. • Switch from persistent to paroxysmal type of AF: recurrent AF episodes last <7days • Arrhythmia burden: percentage of Holter recording time with atrial fibrillation (AF) • Arrhythmia burden: percentage of Holter recording time with atrial tachycardia/flutter (AT) Intra-procedural parameters: • Acute per-procedural termination of persistent AF (for patients ablated in persistent AF) and radiofrequency (RF) ablationduration until AF termination • Total RF time o RF time to achieve PVI o RF time for ablation of atrial tachycardia o RF time for ablation of atrial low voltage areas (group 1 only) • Fluoroscopy time and dose Safety: • Procedural complications: bleeding, cardiac tamponade necessitating pericardiocentesis or surgery, procedure-related death • Late complications: PV stenosis, atrio-esophageal fistula, hospitalization for arrhythmia recurrence, pneumonia, heart failure • (Serious) adverse events, procedure-related death • Prognostic value of acute inducibility for atrial arrhythmias by atrial burst stimulation at the procedure end	—

Measure

Time frame

Efficacy: • Single-procedural freedom of atrial fibrillation (AF) without antiarrhythmic drug treatment after the first ablation procedure (12 months after the ablation procedure) • Multi-procedural freedom of atrial fibrillation (AF) and atrial tachycardia/ flutter (AT) without antiarrhythmic drug treatment 12 months after the last ablation procedure. Note: Re-ablation procedures after the blanking period of 1st ablation procedure are allowed in case of arrhythmia recurrence using the same ablation strategy to which the patient was randomized. • Multi-procedural freedom of atrial fibrillation (AF) without antiarrhythmic drug treatment after the last ablation procedure. • Switch from persistent to paroxysmal type of AF: recurrent AF episodes last <7days • Arrhythmia burden: percentage of Holter recording time with atrial fibrillation (AF) • Arrhythmia burden: percentage of Holter recording time with atrial tachycardia/flutter (AT) Intra-procedural parameters: • Acute per-procedural termination of persistent AF (for patients ablated in persistent AF) and radiofrequency (RF) ablationduration until AF termination • Total RF time o RF time to achieve PVI o RF time for ablation of atrial tachycardia o RF time for ablation of atrial low voltage areas (group 1 only) • Fluoroscopy time and dose Safety: • Procedural complications: bleeding, cardiac tamponade necessitating pericardiocentesis or surgery, procedure-related death • Late complications: PV stenosis, atrio-esophageal fistula, hospitalization for arrhythmia recurrence, pneumonia, heart failure • (Serious) adverse events, procedure-related death • Prognostic value of acute inducibility for atrial arrhythmias by atrial burst stimulation at the procedure end

—

Countries

Germany

Contacts

Public ContactAmir S. Jadidi

Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Kardiologie und Angiologie II – Rhythmologie,

amir.jadidi@universitaets-herzzentrum.de07633 402-4300

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026