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DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

NCT03334630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 482

Last updated 2025-02-13

Study results available
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Summary

The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

Conditions

Interventions

DEVICE

DiamondTemp Ablation catheter

a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

DEVICE

TactiCath Quartz Ablation catheter

a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Josef Kautzner, MD, PhD · Institut klinické a experimentální medicíny (IKEM)

  • William Maddox, MD · University of Alabama at Birmingham

  • Tom McElderry, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2019-11-18
Completion
2019-12-03
FDA Device
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • 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 NCT03334630 on ClinicalTrials.gov