Serial Hybrid Atrial Fibrillation Ablation

NCT01582828 | Withdrawn

• 1 other identifier: SHAFT-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of (long-standing) persistent atrial fibrillation (AF) remains cumbersome and the surgical (epicardial) approach seems to be the most effective. Still, however a significant amount of failures exist which is mostly due to incompleteness of the surgical ablation lines. Checking, and if necessary additional ablation, of these lines afterwards endocardially by the cardiologist (the so-called serial hybrid approach) could overcome this problem.

Conditions

Atrial Fibrillation

Keywords

atrial; fibrillation; pvi; vats; ablation; hybrid

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation Freedom

  left sided atrial flutter and left atrial tachycardia

  12 months

Secondary Outcomes (4)

• re-isolation

  8-10 weeks

• Percentage of cross-over

  1 year

• Complications

  1 year

• Atrial fibrillation Burden

  1 year

Study Arms (2)

Epicardial (surgical) ablation

ACTIVE COMPARATOR

Epicardial Pulmonary vein isolation

Procedure: Epicardial (surgical) ablation

Hybrid

EXPERIMENTAL

Epicardial (surgical) ablation \& Endocardial assessment

Procedure: Hybrid

Interventions

Epicardial (surgical) ablation PROCEDURE

* Pulmonary vein isolation with bipolar clamps and bipolar box lesion * Epicardial atrial appendage closure

Epicardial (surgical) ablation

Hybrid PROCEDURE

Epicardial (surgical) ablation * Pulmonary vein isolation with bipolar clamps and bipolar box lesion * Epicardial atrial appendage closure Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation

Hybrid

Eligibility Criteria

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

You may qualify if:

• patients are screened and accepted for pulmonary vein isolation according to the current guidelines
• long standing persistent or persistent AF as defined in the guidelines
• left atrial size needs to be more than \>46 mm on long axis or \>35 cc/m2
• CHADSVASC score should be more than 0 as an indicator of a substantial substrate for atrial fibrillation.

You may not qualify if:

• Significant coronary artery disease has to be excluded as a trigger for AF by means of cardiac CT, if necessary a coronary angiogram will be performed.
• Previous PVI ablation (epicardial or endocardial) or cardiac surgery.
• Significant valvular disease present on echo.
• Concomitant cardiac surgery needed.

Sponsors & Collaborators

• Medisch Spectrum Twente: lead

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7500AB, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Jurren van Opstal, MD PhD

  Medisch Spectrum Twente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow electrophysiology

Study Record Dates

• First Submitted: April 20, 2012
• First Posted: April 23, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

NL (1)