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DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

NCT03643224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2025-10-23

Study results available
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Summary

The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

Conditions

Interventions

DEVICE

Radiofrequency Ablation

A procedure will be performed using a radiofrequency ablation catheter.

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Atul Verma, MD · Medical Director, Heart Rhythm Program, Southlake Regional Health Centre

  • Andrea Natale, MD · Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-19
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643224 on ClinicalTrials.gov