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Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)

NCT ID: NCT01911897

Last Updated: 2023-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2020-02-28

Brief Summary

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To evaluate the safety and performance of the MobiusHD system in subjects with resistant hypertension.

Detailed Description

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This is an open-label, multicenter, first-in-man clinical trial to be conducted in Europe. Eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the MobiusHD system.

Potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to MobiusHD placement. Qualified patients will undergo placement of the MobiusHD under angiographic visualization, and will then be followed for 36 months.

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MobiusHD

MobiusHD

Group Type EXPERIMENTAL

MobiusHD

Intervention Type DEVICE

Implant that is placed in the carotid sinus to control hypertension.

Interventions

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MobiusHD

Implant that is placed in the carotid sinus to control hypertension.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Office cuff SBP ≥ 160 mmHg measured per protocol instructions following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications.

Exclusion Criteria

* Known or clinically suspected baroreflex failure or autonomic neuropathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vascular Dynamics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Van der Heyden, MD

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

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University of Cologne

Cologne, , Germany

Site Status

Maastricht University Medical Center

Maastricht, AZ, Netherlands

Site Status

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

HagaZiekenhuis

The Hague, , Netherlands

Site Status

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Germany Netherlands

References

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van Kleef MEAM, Devireddy CM, van der Heyden J, Bates MC, Bakris GL, Stone GW, Williams B, Spiering W; CALM-FIM Investigators. Treatment of Resistant Hypertension With Endovascular Baroreflex Amplification: 3-Year Results From the CALM-FIM Study. JACC Cardiovasc Interv. 2022 Feb 14;15(3):321-332. doi: 10.1016/j.jcin.2021.12.015.

Reference Type RESULT
PMID: 35144789 (View on PubMed)

Spiering W, Williams B, Van der Heyden J, van Kleef M, Lo R, Versmissen J, Moelker A, Kroon A, Reuter H, Ansel G, Stone GW, Bates M; CALM-FIM_EUR investigators. Endovascular baroreflex amplification for resistant hypertension: a safety and proof-of-principle clinical study. Lancet. 2017 Dec 16;390(10113):2655-2661. doi: 10.1016/S0140-6736(17)32337-1. Epub 2017 Sep 1.

Reference Type DERIVED
PMID: 28870716 (View on PubMed)

Habib N, Mahmoodi BK, Bos WJ, Tromp SC, Suttorp MJ, Bates MC, Van der Heyden J. Initial experience with therapeutic geometric modification of the carotid bulb for true resistant hypertension. EuroIntervention. 2015 May;11(1):117-20. doi: 10.4244/EIJV11I1A20.

Reference Type DERIVED
PMID: 25982654 (View on PubMed)

Other Identifiers

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CRD0120, CRD0233

Identifier Type: -

Identifier Source: org_study_id