Surgical or Catheter Ablation of Lone Atrial Fibrillation (AF) Patients

NCT00703157 | Terminated Results

• 1 other identifier: BRC-CS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective randomized interventional trial comparing the efficacy of circumferential pulmonary vein ostia ablation using surgical versus catheter techniques in the treatment of paroxysmal atrial fibrillation. Success rate determined by REVEAL-XT (AF implantable monitoring device).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Change in AF Burden After Ablation Therapy Measured With REVEAL-XT Implantable Device.

  AF Burden is defined as the percentage of time during the follow-up period that a subject is in AF, as measured by the REVEAL-XT implantable device.

  Baseline through 3-6 months post-ablation

Secondary Outcomes (10)

• Treatment Failures Requiring Redo or Alternative Therapy

  Time from procedure until 6 months post-ablation

• Number of Subjects With Adverse Events, Associated With the Ablation Procedure

  Time from procedure

• Mortality and Hospitalization

  Time from procedure until 24 months post-ablation

• Duration, Burden and Costs of Treatment Procedures

  Through 24 months post- ablation

• Reduced Number, Duration and Severity of AF Symptoms

  Through 24 months post-ablation

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: Catheter Ablation

Procedure: Catheter Ablation

2

ACTIVE COMPARATOR

Arm 2: Surgical Ablation.

Procedure: Surgical Ablation

Interventions

Catheter Ablation PROCEDURE

Patients undergoing left atrial circumferential pulmonary vein ostia ablation.

1

Surgical Ablation PROCEDURE

patients undergoing left atrial circumferential pulmonary vein ostia ablation via minimal invasive surgery.

2

Eligibility Criteria

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

You may qualify if:

• Patient has documented Paroxysmal AF as defined by the ACC/AHA/ESC guidelines
• Minimal one documented AF episode in the last 6 months
• Refractory to minimal two Class I or III anti-arrhythmic drug
• Age \> 18 years
• Signed and dated the Patient Informed Consent.
• Patient can tolerate anti-coagulation therapy (Warfarin/Coumadin)

You may not qualify if:

• Patient has a structural heart disease
• Ejection fraction \< 40 %
• Echocardiographic evidence for a left atrium \> 45 mm (parasternal axis)
• Patients on amiodarone, or patients known to be intolerant for amiodarone
• Dextrocardia, current endocarditis, systemic infection, renal failure
• Patient has known cerebrovascular disease, including a history of stroke, CVA or TIA
• Pregnancy at enrolment; or planned pregnancy within the follow up period
• Patient has a life expectancy less than 1 year
• The subject is participating in another device or drug study
• The patient is unable and/or unwilling to cooperate with study procedures or required follow up visits
• Echocardiographic (TTE) evidence for presence of left atrial thrombus
• Previous (cardio-) thoracic surgery
• Previous left atrial ablation
• Patients with permanent or persistent AF

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

Related Publications (2)

• Buist TJ, Adiyaman A, Beukema RJ, Smit JJJ, Delnoy PPHM, Hemels MEW, Sie HT, Ramdat Misier AR, Elvan A. Quality of life after catheter and minimally invasive surgical ablation of paroxysmal and early persistent atrial fibrillation: results from the SCALAF trial. Clin Res Cardiol. 2020 Feb;109(2):215-224. doi: 10.1007/s00392-019-01504-z. Epub 2019 Jun 24.

  PMID: 31236689 DERIVED

• Adiyaman A, Buist TJ, Beukema RJ, Smit JJJ, Delnoy PPHM, Hemels MEW, Sie HT, Ramdat Misier AR, Elvan A. Randomized Controlled Trial of Surgical Versus Catheter Ablation for Paroxysmal and Early Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2018 Oct;11(10):e006182. doi: 10.1161/CIRCEP.118.006182.

  PMID: 30354411 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Limitations and Caveats

The study stopped early, prior to meeting the target number of subjects per group. The reported results and conclusions are based on these limited data.

Results Point of Contact

• Title: Ber Kleijnen
• Organization: Medtronic Bakken Research Center, Coronary and Structural Heart Disease Management

ber.kleijnen@medtronic.com

+31 (0) 43 356 6566

Study Officials

• Hauw Sie, MD

  Isala

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 23, 2008
• Study Start: November 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2016
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)