Trial document




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  DRKS00010429

Trial Description

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Title

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

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Trial Acronym

SOLVE-AF

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

This is an investigator-initiated, interventional, multicentre, open study conduced in 8 centers in Germany. The objective is to investigate if patients eligible for first ablation procedure for symptomatic persistent AF benefit from a combined ablation therapy including pulmonary vein isolation (PVI) and catheter ablation of atrial low voltage areas compared to PVI only. For diagnosis and treatment standard procedures are used.
Initially all patients are treated with PVI and undergo a mapping of the atrium for detection of atrial low voltage areas. Patients with presence of atrial low voltage areas will be randomized during the procedure to either “PVI plus selective ablation of atrial low voltage sites” (Group 1) or to conventional PVI (Group 2: “PVI-only”). Patients without atrial low voltage areas will not be randomized but be assigned to the registry group (Group 3) receiving PVI only.
Due to structural remodelling clinical benefit (freedom of arrhythmia) can be evaluated at the earliest three months after the intervention. If arrhythmia reoccur after the three months blanking period patients will be re-ablated according to the previous allocation to one of the study groups.
The primary endpoint is single-procedural freedom of arrhythmia (atrial fibrillation and atrial tachycardia/ flutter) without antiarrhythmic drug treatment within 12 months following the first ablation procedure. Secondary endpoints include freedom of arrhythmia without antiarrhythmic drug treatment 12 months after the first ablation procedure and multi-procedural freedom of arrhythmia without antiarrhythmic drug treatment 12 months after the last ablation procedure, intra-procedural parameters and safety.
Follow-up is identical for the study groups and will be conducted according to routine standards. At two study specific time points 6 and 12 months after procedure 7-day holter monitoring will be done.
Because of the treatment procedure investigators cannot be blinded; patients too will not be blinded.
Since symptoms often recur in patients with persistent VHF treated with PVI only and require further treatment the study will provide important information on the benefit an risk of an additional ablation of atrial low voltage areas.

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Organizational Data

  •   DRKS00010429
  •   2017/08/10
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  •   yes
  •   Approved
  •   564/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I48.1 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   Patients with atrial low voltage areas (randomized): Pulmonary vein isolation and selective ablation of atrial low voltage areas
  •   Patients with atrial low voltage areas (randomized): Pulmonary vein isolation
  •   Patients without atrial low voltage areas (not randomised), registry group: Pulmonary vein isolation
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/08/08
  •   450
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1. Age ≥18 years and <80 years
2. Eligibility for first ablation procedure for symptomatic persistent AF (>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

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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 (<7 days persisting)
4. Patients with long standing 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

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Addresses

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    • Universitäts-Herzzentrum Freiburg-Bad Krozingen
    • Mr.  Dr.   Amir  Jadidi 
    • 79189  Bad Krozingen
    • Germany
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    • Universitätsklinikum Freiburg - Studienzentrum -
    • Ms.  Dr. rer. nat.  Lydia  Herbstritt 
    • Elsässer Str. 2
    • 79110  Freiburg
    • Germany
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    • Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Kardiologie und Angiologie II – Rhythmologie
    • Mr.  Dr. med.  Amir S.  Jadidi 
    • Südring 15,
    • 79189  Bad Krozingen
    • Germany
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    • Universitäts-Herzzentrum Freiburg-Bad Krozingen, Klinik für Kardiologie und Angiologie II – Rhythmologie,
    • Mr.  Dr. med.  Amir S.  Jadidi 
    • Südring 15,
    • 79189  Bad Krozingen
    • Germany
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Sources of Monetary or Material Support

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    • St. Jude Medical GmbH
    • Helfmann-Park 7
    • 65760  Eschborn
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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