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NCT04037397CompletedPhase 3

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment (RAAFT-3)

First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Persistent Atrial Fibrillation Treatment

Source: ClinicalTrials.gov · Last updated 12 Nov 2024

Brief summary (registry, in English)

The purpose of this study is to determine if catheter-based atrial fibrillation (AF) ablation is superior to treatment with antiarrhythmic drugs as a first-line therapy for symptomatic persistent AF.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
25 (actual)
First submitted
25 Jul 2019
Start date
24 Sept 2019
Primary completion date
1 Oct 2024
Lead sponsor
University of Pennsylvania
NCT number
NCT04037397

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 25
  • From 24 Sept 2019 to the primary completion date, 1 Oct 2024
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
  • Previous left heart ablation procedure, either by surgery or by percutaneous catheter, for atrial fibrillation.
  • Current enrollment in another investigational drug or device study.
  • Previous use of an antiarrhythmic drug, including amiodarone, propafenone, flecainide, sotalol, quinidine, dofetilide, dronedarone (see below for specifications: Antiarrhythmic Drug Group).

Other illness

  • Documented severe valvular disease (aortic stenosis, mitral regurgitation, tricuspid regurgitation or presence of mechanical cardiac valves), active coronary artery disease (defined as the presence of \>70% stenosis of coronary arteries or documentation of active myocardial ischemia), recent (within 6 months) CABG.
  • Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the Patient for the entire study period.
  • Increase risk of bleeding, current peptic ulceration, proliferative diabetic retinopathy, history of severe systemic bleeding, or other history of bleeding diathesis or coagulopathy.
  • Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD).
  • Evidence of active cardiac or systemic infection.
  • Medical condition limiting expected survival to less than one year.

Lab values

  • Documented LVEF \<40%.
  • Contraindication for the use of all antiarrhythmic drugs including sotalol, dofetilide, amiodarone and 1C antiarrhythmic drugs (liver enzymes and serum creatinine that are outside the upper normal lab values, e.g. \> 3 times ULN with 2 abnormal lab values). \[Note: Participants will not be excluded if they are able to take any single or combination of drugs without contraindications\]

Other

  • Documented left atrial diameter \>/=6cm.
  • Moderate to severe LVH (LV wall thickness \>1.5cm).
  • Absolute contra-indication to the use of heparin and or oral anticoagulation.
  • Documented intra-atrial thrombus, tumor, or another abnormality, which precludes left atrial catheter ablation.
  • Women with a positive pregnancy test.

Who the study is looking for

  • Eligible patients have a history of persistent AF with at least 2 episodes in the 9 months prior to enrollment. Persistent AF is defined according to 2014 AHA/ACC/HRS guidelines as continuous AF that is sustained for more than 7 days.Patients are enrolled if they are:
  • Older than 18.
  • Symptomatic with persistent AF.
  • Experienced at least one AF episode that was documented by surface ECG, 6 months before randomization.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MetroHealth
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Penn Presbyterian Medical Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pennsylvania
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
University of Arizona
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.