Clinical trial NCT01911897: Controlling and Lowering Blood Pressure With The MOBIUS HD™ (CALM-FIM_EUR)
Official title: CALM-FIM_EUR - Controlling and Lowering Blood Pressure With the MobiusHD - A Prospective Multicenter Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Vascular Dynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: 36 months
Secondary outcomes:
measure: Systolic Office Cuff Blood Pressure (BP)
timeFrame: Baseline, discharge (up to 2 days), 7 days, 1 month, 3 months, 6 months
measure: Mean 24-hour Systolic Ambulatory Blood Pressure (ABPM) at 6 Months
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: AZ
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: The Hague
country: Netherlands
facility: HagaZiekenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Jan Van der Heyden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.