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Completed

NCT Number: NCT02064764

Renal Nerve Denervation in Patients With Hypertension and Paroxysmal and Persistent Atrial Fibrillation

The purpose of this clinical study is to evaluate the feasibility of performing both renal nerve denervation and pulmonary vein isolation on the same patient with the intent of characterizing both safety and effectiveness in a paroxysmal and persistent atrial fibrillation population with hypertension. To assess safety, the study will measure the occurrence of a composite safety endpoint and, to assess effectiveness, the study will measure freedom of chronic treatment failure through a minimum of six months of follow-up.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum des Saarlandes, Homburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Drug refractory recurrent symptomatic paroxysmal or persistent atrial fibrillation
  • Office-based systolic blood pressure of ≥140 mm Hg based despite treatment with 1 or more antihypertensive medications
  • Age 18 years to 80 years old.

Key Exclusion Criteria:

  • Renal artery anatomy that is ineligible for treatment including: Lacks at least one renal artery for each kidney with ≥3 mm diameter and minimum treatable length per the Spyral Instructions for Use, Renal artery stenosis (>50%) or renal artery aneurysm in either renal artery, A history of prior renal artery intervention including balloon angioplasty or stenting, Renal artery which contain calcification which does not allow at least four radio frequency ablations to be delivered , Diffuse fibromuscular dysplasia (FMD) or FMD which does not allow at least four radio frequency ablations to be delivered; FMD defined as visible beading of the artery on angiography , Unilateral kidney.
  • Estimated Glomerular Filtration Rate of <30 mL/min/1.73m2.
  • Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
  • Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager.

Treatment and study plan

Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter

Device

Arctic Front Advance™ Cardiac Cryoablation System

Device

Primary outcomes

  1. Proportion of Subjects in Each Arm That Experience Safety Composite Events

    Time frame: Up to one or six months post procedure depending on the event

    Characterize the rate of safety composite events, (End stage renal disease, Death, Significant Embolic Event, Renal Artery Perforation or Dissection Requiring Intervention, Vascular Complications, Hospitalization for Hypertensive Crisis, New Renal Artery Stenosis, Cardiac Damage, Pulmonary Vein Stenosis, Atrio-Esophageal Fistula, Arrhythmia, Persistent Phrenic Nerve Palsy), within each of the two study arms and also characterize the difference in the rates between study arms. Each event in the composite has its own time frame, either one month or six months post procedure.

  2. Proportion of Patients With Chronic Treatment Success

    Time frame: Minimum of six months

    Chronic treatment success is freedom from chronic treatment failure. Chronic treatment failure is defined as the occurrence of either a documented episode of AF lasting 2 or more minutes (as measured by an implantable loop recorder) or an intervention for AF.

Secondary outcomes

  1. Change in Office Systolic and Diastolic Blood Pressure at 6 Months From Baseline

    Time frame: 6 months

    Compare the difference of office systolic and diastolic blood pressure at 6 months and baseline between study arms.

  2. Difference in Heart Rate at 6 Months and Baseline

    Time frame: 6 months

    Compare the difference in heart rate using the 6 month follow-up measurement and baseline visit measurement. These values will then be compared between study arms.

  3. Procedural Measures

    Time frame: Procedure

    Elapsed fluoroscopy time and cryocatheter procedure time between study arms. Renal Denervation Procedure Time and Total Procedural Time will be reported only for the Cryoablation and Renal Denervation group.

  4. Proportion of Participants With Symptoms at 6 Months Between Study Arms

    Time frame: 6 months

    The endpoints for this objective are presence of the following arrhythmic symptoms as recorded at the 6-month visit through discussion with the patient at the time of the visit:

    • Dizziness
    • Palpitations
    • Rapid heart beat
    • Dyspnea
    • Fatigue
    • Syncope
    • Other

  5. Rate of Chronic Treatment Success (Primary Effectiveness Endpoint) for Subjects Off of Class I and III Anti-arrhythmic Drugs Following the Blanking Period.

    Time frame: 6 months

    Compare the rate of chronic treatment success (primary effectiveness endpoint) between study arms for subjects off of Class I and III anti-arrhythmic drugs following the blanking period.

  6. Percent of Time in AF Burden Over All Follow-up Occurring After the Blanking Period

    Time frame: 91 days after the cryoablation procedure date until the last Reveal LINQ device data date.

    Compare the Percent of time in AF burden over all follow-up occurring after the blanking period between study arms.

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Acronym: Symplicity AF

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2014
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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