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Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation

Randomized Study Comparing Pulmonary Vein Isolation Alone vs. Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00196183
Enrollment
98
Registered
2005-09-20
Start date
2004-08-31
Completion date
2006-06-30
Last updated
2008-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREtrigger-guided catheter-ablation

trigger-guided ablation of paroxysmal atrial fibrillation

PROCEDUREtrigger+substrate-guided catheter ablation

trigger-+substrate guided ablation of paroxysmal atrial fibrillation

Sponsors

Deutsches Herzzentrum Muenchen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablationSinus rhythm in follow-up in the absence of antiarrhythmic drugs after the first catheter ablation

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026