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NCT03334630 · ClinicalTrials.gov registry record · NA
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
A NA study, sponsored by Medtronic Cardiac Ablation Solutions.
- Completed
- Registry status
- NA
- Development phase
- 482
- Enrollment target
NCT03334630: Completed NA study, sponsored by Medtronic Cardiac Ablation Solutions.
NCT03334630 is a NA study that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 482 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03334630, a NA study, has completed, sponsored by Medtronic Cardiac Ablation Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 482 participants
- Enrollment target
Study 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.
Primary Outcome
The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * C
Interventions
- DEVICE DiamondTemp Ablation catheter
- DEVICE TactiCath Quartz Ablation catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2019-12-03 |
| Phase | NA |
What the finished NCT03334630 record still lists
NCT03334630 is an interventional study that assigns participants to a tested intervention. The registered 482 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which DiamondTemp Ablation catheter is the first listed.
NCT03334630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03334630 about?
NCT03334630 is a clinical study titled "DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation". 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.
What is the current status of trial NCT03334630?
This trial is currently completed. It is a NA study. The enrollment target is 482 participants. The study started on 2017-11-06. Estimated completion is 2019-12-03.
What interventions are being tested in trial NCT03334630?
The interventions under investigation include: DiamondTemp Ablation catheter (DEVICE), TactiCath Quartz Ablation catheter (DEVICE).
Who is sponsoring clinical trial NCT03334630?
This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03334630's enrollment target sits among peer trials
482 216th of 2000 higher than 1,785 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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