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Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

G

German Heart Center Munich

Status and phase

Completed
Phase 4

Conditions

Atrial Fibrillation

Treatments

Procedure: trigger+substrate-guided catheter ablation
Procedure: trigger-guided catheter-ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT00196183
GE IDE No. C00504

Details and patient eligibility

About

The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation.

Full description

Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation (AF). However, discussion about the best ablation strategy is still ongoing.

In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV) eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation approach targeting in both atria fractionated, complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described. The first describer of this technique reports curing rates of 92%. We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment.

Enrollment

98 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 and <80 years
  • Symptomatic paroxysmal atrial fibrillation
  • Drug-refractory
  • Anticoagulation

Exclusion criteria

  • Hyperthyreosis
  • Moderate-to-severe mitral valve valvulopathy
  • LV-ejection fraction <35%
  • Prior ablation, PCI or heart surgery <3 months
  • Left atrial thrombus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

98 participants in 2 patient groups

1
Experimental group
Description:
trigger-guided ablation of paroxysmal atrial fibrillation
Treatment:
Procedure: trigger-guided catheter-ablation
2
Experimental group
Description:
trigger-+substrate guided ablation of paroxysmal atrial fibrillation
Treatment:
Procedure: trigger+substrate-guided catheter ablation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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