Comparing Surgical Management Methods of Atrial Fibrillation

Conditions

• Atrial Fibrillation

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Atrial Fibrillation Ablation — PROCEDURE
  Ablation of the heart to reduce Afib Occurrence

Study Details

Compare the efficacy of the left atrial Cox-Maze IV lesion set versus the Tampa 2 lesion set versus the EnCompass ablation alone, in the surgical treatment of atrial fibrillation at one year post-operatively.

Key Dates

Start date

Sep 15, 2025

Status verified

Apr 2026

Primary completion

Sep 15, 2027

Completion

Sep 15, 2032

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Cox-Maze IV
  Lesion created around the pulmonary vein ostia (openings). Lesion to posterior (back) of the mitral annulus (fibrous ring around the mitral valve leaflets). Lesion from the 'box' to the left atrial appendage. There is also one lesion on the outside of the heart at the coronary sinus (main vein draining the heart)- not shown in this picture due to being on the outside of the heart. The Left Atrial Appendage will also be either excluded or removed.
• Active Comparator: Tampa 2
  Lesion created around the pulmonary vein ostia (openings). Lesion from the 'box' to the left atrial appendage Lesion from the left atrial appendage to the anterior (front) of the mitral annulus (fibrous ring around the mitral valve leaflets). This lesion is done through the left atrial appendage. The Left Atrial Appendage will also be either excluded or removed.
• Active Comparator: Encompass Alone
  Lesion created around the pulmonary vein ostia (openings). The Left Atrial Appendage will also be either excluded or removed.

Primary Outcome Measure

Freedom from Atrial Fibrillation [ Time Frame: 30 days and 1 year ]

Locations (1)

Find similar trials in Grand Rapids, MI

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