Atrial Fibrillation Progression Trial

NCT01570361 | Terminated Phase 4 Results DMC FDA Device

• 1 other identifier: ATTEST
• Study Type: interventional
• Target: 255
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine whether early radiofrequency (RF) ablation treatment, using the CARTO® 3 or CARTO® XP System, and THERMOCOOL® Catheter Family (including THERMOCOOL® SF or THERMOCOOL® SMARTTOUCH™) in subjects with paroxysmal atrial fibrillation (PAF), delays progression of atrial fibrillation (AF) compared with drug therapy (either rate or rhythm control) using current AF management guidelines.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Outcome Measures

Primary Outcomes (1)

• Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Years

  Persistent atrial fibrillation/atrial tachycardia (AF/AT) (excluding isthmus-dependent atrial flutter) was defined as AF/AT lasting longer than 7 consecutive days or requiring termination by cardioversion after 48 hours.

  3 years

Secondary Outcomes (10)

• Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year

  1 year

• Time to Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years

  2 years

• Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 1 Year

  1 year

• Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 2 Years

  2 Years

• Percentage of Participants With Persistent Atrial Fibrillation/Atrial Tachycardia at 3 Year

  3 year

Study Arms (2)

Catheter Ablation

EXPERIMENTAL

Radiofrequency catheter ablation treatment in subjects with Paroxysmal Atrial Fibrillation (PAF)

Device: Catheter Ablation

Drug Treatment

ACTIVE COMPARATOR

Drug therapy (either rate or rhythm control) using current AF management guidelines

Drug: Drug Treatment

Interventions

Catheter Ablation DEVICE

Treat subjects with Paroxysmal Atrial Fibrillation (PAF)

Also known as: CARTO® 3 or CARTO® XP System and THERMOCOOL® Catheter Family

Catheter Ablation

Drug Treatment DRUG

Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.

Also known as: Antiarrhythmic Drugs

Drug Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recurrent paroxysmal atrial fibrillation (AF) for at least 2 years, with ≥ 2 episodes over the last 6 months; (per Amendment v3, 09APR2013, previous "6 episodes" )
• HATCH Score of at least ≥1 and ≤4.
• Eligible for catheter ablation and for anti-arrhythmic or rate control medications, after having failed at least 1 but no more than 2 prescribed drugs (either anti-arrhythmic or rate control drug).
• Age 60 years or older.
• Left atrium (LA) diameter ≤ 55mm by TTE.
• Left ventricle (LV) ejection fraction ≥50% when in sinus rhythm or LV ejection fraction ≥35% when in atrial fibrillation.
• NOTE: For patients entering the study in AF with an ejection fraction ≥35% and \<50%; the ejection fraction should be re-checked when in sinus rhythm. In case the ejection fraction is \>50% the subject can continue in the study.
• Patient signed the Informed Consent Form and is able and willing to comply with protocol requirements, including all baseline and follow-up testing.

You may not qualify if:

• Patients awaiting cardiac transplantation or other cardiac surgery.
• Acute illness (ongoing) or active systemic infection or sepsis which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant of the study.
• Reversible causes of atrial fibrillation, e.g. but not limited to thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma, etc.
• Recent cardiac events including myocardial infarction (MI), percutaneous coronary intervention (PCI), or valve or bypass surgery in the preceding 3 months.
• Heart failure decompensation.
• Previously diagnosed with persistent/permanent atrial fibrillation/ atrial flutter.
• Previously required cardioversion \>48 hours after onset of atrial fibrillation/ atrial flutter.
• Subject having previous transischemic attack (TIA) or stroke (cerebrovascular accident) one year prior to patient enrolment and/or no sufficient recovery.
• Pulmonary embolism or recent atrial embolism/thrombosis.
• Hypertrophic obstructive cardiomyopathy.
• Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation).
• Mandated anti-arrhythmic drug therapy for disease conditions other than atrial fibrillation.
• Heritable arrhythmias or increased risk for torsade de pointes with class I or III Drugs.
• Prior left atrial catheter ablation with the intention of treating atrial fibrillation; prior surgical interventions for AF such as the MAZE procedure.
• Prior AV nodal ablation.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Interventions

Catheter Ablation; Anti-Arrhythmia Agents

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

As the study was terminated early without having met primary effectiveness or futility criteria, the study results should be interpreted with caution.

Results Point of Contact

• Title: Liesbeth Vanderlinden
• Organization: Johnson & Johnson Medical N.V., Biosense Webster

lvanderl@its.jnj.com

+32 (0) 2 746 3446

Study Officials

• Karl-Heinz Kuck, MD

  Asklepios Klinik St. Georg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 4, 2012
• Study Start: February 13, 2012
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: February 4, 2025
• Results First Posted: May 14, 2020

Record last verified: 2025-01