Cleveland Clinic Among First Hospitals to Perform New Tissue-Sparing Ablation Procedure

Following the U.S. Food and Drug Administration’s approval last month, Cleveland Clinic was one of the first health systems to use pulsed field ablation (PFA) technology to treat several patients successfully.

During a traditional ablation procedure, a catheter is guided to the interior of the heart and extreme temperatures destroy areas associated with abnormal heart rhythms. This can lead to injury of surrounding structures. PFA relies on tissue-selective, non-thermal electric fields to ablate heart tissue avoiding such injury.

The FDA approval follows data from the ADVENT and PULSED AF clinical trials, in which Cleveland Clinic was a participant. Results showed the therapy was as safe and effective as conventional thermal ablation. This new ablation technology is an alternative for patients with symptomatic atrial fibrillation (Afib).

Atrial fibrillation is an irregular heart rhythm that begins in your heart’s upper chambers. Symptoms include fatigue, heart palpitations, trouble breathing and dizziness. Untreated Afib can lead to a stroke. More common in older adults, more than 33 million have been diagnosed globally.

“This is an important step forward in treatment options for patients with Afib,” said Oussama Wazni, M.D., MBA, section head of Cardiac Electrophysiology and Pacing at Cleveland Clinic. “As part of the trial, our physicians were able to learn how the new therapy works and we found in addition to being safer, it saved time in the operating room.”