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WithdrawnNCT01505296CABALUpdated Dec 16, 2014

Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

A Phase 4 interventional study of Antiarrhythmic drug and Catheter ablation in Atrial Fibrillation, sponsored by Valley Health System. Withdrawn at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2014-12-16.

Sponsored by Valley Health System · Phase 4, Interventional, and Treatment

Why this study was withdrawn
Never initiated
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Sex
All
01

Study summary

The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Read the detailed description

Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Catheter ablation
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

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Lead sponsor

Valley Health System is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with Class IC or class III AAD
  • Previous AF ablation procedure
  • Congestive heart failure (NYHA III-IV functional class)
  • Left Ventricle ejection fraction less than 35%
  • Left atrial diameter > 55mm
  • Unwillingness to participate
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Antiarrhythmic drug

    Class I or III antiarrhythmic drug

    Drug: Antiarrhythmic drug

  • Experimental
    Catheter ablation

    Pulmonary vein isolation

    Procedure: Catheter ablation

Interventions

  • DrugAntiarrhythmic drug

    propafenone, flecainide, sotalol, dofetilide

    Also known as: Rhythmol, Tambocor, Betapace, Tikosyn

  • ProcedureCatheter ablation

    Complete PVI

    Also known as: Thermocool

06

What researchers measure

Primary outcomes

  1. Percentage of AF burden

    The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)

    Time frame: 4 months

Secondary outcomes

  1. All-death death

    All-cause death, thromboembolic events, hospitalizations, procedural complications, drug adverse effects, and number of crossovers

    Time frame: 4 months

07

Study locations

2 sites
  • Valley Health System
    Ridgewood, New Jersey 07450, United States
  • State Research Institute of Circulation Pathology
    Novosibirsk, Russian Federation
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01505296
Lead sponsor
Valley Health System
Collaborators
Biosense Webster, Inc.
Responsible party
Jonathan Steinberg,MD (Director Arrhythmia Services, Valley Health System, Valley Health System) — Principal investigator
First posted
Jan 6, 2012
Start date
Dec 2011
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Dec 16, 2014

Study contacts

Jonathan Steinberg, MD
principal investigator · Valley Health System
Evegny Pokushalou, MD
principal investigator · State Resarch Institute of Circulation Pathology, Novosibirsk, Siberia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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