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A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach

A New Approach to Target the Substrates of Persistent Atrial Fibrillation: The Sequential Substrate Ablation Approach

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02654353
Enrollment
100
Registered
2016-01-13
Start date
2012-02-29
Completion date
2015-12-31
Last updated
2016-01-13

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

Conditions

Persistent Atrial Fibrillation

Keywords

Persistent atrial fibrillation, catheter ablation, outcome

Brief summary

This is a prospective randomized controlled trial that compares the conventional stepwise approach with a new sequential substrate ablation approach for persistent atrial fibrillation.

Detailed description

A total number of 100 patients with persistent AF were randomized to receive either conventional stepwise ablation (conventional group) or a sequential substrate ablation (substrate group), both with the endpoint of AF termination. All patients were in AF before the procedure. The sequential substrate ablation consisted of pulmonary vein isolation (PVI) followed by cardioversion and linear ablation at the mitral isthmus, left atrial roof and cavotricuspid isthmus in order to modify the AF substrate. After achievement of bidirectional block, AF was re-induced and electrogram-based ablation was performed to achieve AF termination to sinus rhythm (SR). Endpoints are single-procedure outcome and total amount of RF ablation time required to terminate AF by electrogram-guided ablation.

Interventions

PROCEDUREAblation

In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms.

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* persistent atrial fibrillation lasting longer than 3 months * no previous ablations * at least 1 electrical cardioversion

Exclusion criteria

* non-persistent atrial fibrillation * previous ablation procedures

Design outcomes

Primary

MeasureTime frame
Number of patients without any arrhythmias during follow-up of 12 months12 months

Countries

Germany

Outcome results

None listed

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